271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146

  
534 trials found
No.TrialIDDate_
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1NCT05666115
(ClinicalTrials.gov)
January 2, 202322/11/2022Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot StudyEfficacy of Modification of Lifestyle in the Treatment of Ankylosing SpondylitisArthritis;Rheumatic Diseases;Autoimmune DiseasesDietary Supplement: Probiotic group;Other: Exercise groupCamilo Jose Cela UniversityNULLActive, not recruiting18 Years60 YearsAll12N/ASpain
2ITMCTR2200006601
2022-09-152022-09-15Observation of curative effect of Du-moxibustion on patients with active ankylosing spondylitisClinical evaluation and mechanism study of moxibustion on Du meridian in the treatment of active ankylosing spondylitis ankylosing spondylitishealthy group:Oral celecoxib;therapy group:Du-Moxibustion (Moxibustion of Governor Vessel);Affiliated Hospital of Shandong University of Traditional Chinese MedicineNULLRecruiting1860Bothhealthy group:30;therapy group:30;China
3NCT05407246
(ClinicalTrials.gov)
June 24, 202230/5/2022Phase II Study of Hemay005 in Patients With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study on the Efficacy and Safety of hemay005 Tablets in the Treatment of Active Ankylosing SpondylitisActive Ankylosing SpondylitisDrug: Hemay005Tianjin Hemay Pharmaceutical Co., LtdNULLNot yet recruiting18 Years65 YearsAll90Phase 2China
4NCT05427942
(ClinicalTrials.gov)
June 3, 202217/6/2022Yuflyma® (Adalimumab), Patient Experience After SwitchingYUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU-MATTER StudyRheumatoid Arthritis;Ankylosing Spondylarthritis;Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis;Psoriatic Arthritis;Crohn Disease;Ulcerative ColitisDrug: AdalimumabCelltrion HealthCare FranceNULLRecruiting18 YearsN/AAll300France
5NCT05527444
(ClinicalTrials.gov)
March 15, 20226/5/2022The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis PatientsThe Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis PatientsAnkylosing SpondylitisDrug: Secukinumab 150 mg/ml;Drug: Adalimumab Ab;Drug: NSAID;Drug: Thalidomide PillQilu Hospital of Shandong UniversityNULLRecruiting18 Years65 YearsAll100Phase 4China
6NCT05379049
(ClinicalTrials.gov)
March 1, 20227/5/2022Therapeutic Response to Tumor Necrosis Factor-alpha (TNF-alpha) Antagonists in Rheumatoid Arthritis.Evaluation of the Therapeutic Response to TNF-alpha Antagonist (Etanercept, Infliximab, Adalimumab) in Patients With Rheumatoid Arthritis; Using Plasma TNF-alpha as a Competent Biomarker. Single Center Study in Sulaymaniyah/ IraqRheumatoid Arthritis;Inflammatory Arthritis;Ankylosing SpondylitisBiological: Infliximab: Adalimumab; EtanerceptUniversity of SulaimaniNULLRecruiting18 YearsN/AAll80Iraq
7NCT05164198
(ClinicalTrials.gov)
January 15, 20228/11/2021Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease ActivityMulticenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease ActivityAnkylosing Spondylitis;Axial SpondyloarthritisBiological: Adalimumab and its biosimilars;Biological: Biological: Etanercept and its biosimilars;Biological: Golimumab;Biological: Infliximab biosimilarHanyang University Seoul HospitalLinical KoreaNot yet recruiting18 Years65 YearsAll448Phase 4NULL
8NCT04876781
(ClinicalTrials.gov)
January 12, 202220/4/2021Korean Post-marketing Surveillance for Xeljanz XRKorean Post-marketing Surveillance for Xeljanz XR (Registered)Active Moderate to Severe Rheumatoid Arthritis;Active Ankylosing SpondylitisDrug: Tofacitinib XRPfizerNULLRecruiting18 YearsN/AAll200Korea, Republic of
9ChiCTR2100054201
2022-01-012021-12-11Effectiveness and Economic Evaluation of Intervention in Chinese Patients with Active Ankylosing Spondylitis under the Ankylosing Spondylitis Healthy Village Project: A Real-World Prospective Observational StudyEffectiveness and Economic Evaluation of Intervention in Chinese Patients with Active Ankylosing Spondylitis under the Ankylosing Spondylitis Healthy Village Project: A Real-World Prospective Observational Study Ankylosing SpondylitisIntervention group:Etanercept 25mg each time, twice a week, with an interval of 3-4 days;Control group:Traditional treatment;West China Hospital of Sichuan UniversityNULLRecruitingBothIntervention group:3000;Control group:1000;N/AChina
10NCT04924270
(ClinicalTrials.gov)
January 20227/6/2021Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory DiseasesSafety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory TrialRheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative ColitisBiological: Faecal microbiota transplantation;Other: PlaceboTorkell EllingsenRegion of Southern Denmark;University of Southern DenmarkNot yet recruiting18 Years70 YearsAll200Phase 2NULL
11ChiCTR2100051907
2021-12-072021-10-09Governor Vessel Moxibustion Therapy Improves Microbiota Structure in Ankylosing Spondylitis PatientsGovernor Vessel Moxibustion Therapy Improves Microbiota Structure in Ankylosing Spondylitis Patients Ankylosing spondylitisExperimental group:Governor vessel moxibustion therapy treatment;Control group:Medical treatement;The Affiliated Hospital of Shandong Academy of Medical SciencesNULLPendingMaleExperimental group:15;Control group:15;N/AChina
12NCT05094128
(ClinicalTrials.gov)
November 22, 202120/10/2021A Study to Assess Disease Activity in Adult Participants With Ankylosing Spondylitis Who Receive Upadacitinib in a Real-world SettingEffectiveness of Upadacitinib in Patients With Ankylosing Spondylitis Suffering From Typical Disease Activity and Pain in a Real-World SettingRadiographic Axial Spondylarthritis (r-axSpA)Drug: UpadacitinibAbbVieNULLRecruiting18 YearsN/AAll352Germany
13ChiCTR2100052323
2021-10-282021-10-24The treatment of Ankylosin Spondylitis by Bushenqiangduqinghuatang: A randomized controlled clinical trialThe treatment of Ankylosin Spondylitis by Bushenqiangduqinghuatang: A randomized controlled clinical trial ankylosing spondylitistreatment group:Bushenqiangduqinghuatang and celecoxib;Control group :celecoxib;China-Japan Friendship HospitalNULLRecruiting16?Bothtreatment group:41;Control group :41;China
14EUCTR2019-004108-37-CZ
(EUCTR)
14/10/202109/03/2021A study to determine how effective and safe the drug CC-99677 is for patients with active Ankylosing SpondylitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CC-99677 60mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Product Code: CC-99677 30mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 2United States;Czechia;Czech Republic;Canada;Spain;Poland;Turkey;Romania;Russian Federation;Germany
15EUCTR2019-004108-37-PL
(EUCTR)
13/09/202101/04/2021A study to determine how effective and safe the drug CC-99677 is for patients with active Ankylosing SpondylitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CC-99677 60mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Product Code: CC-99677 30mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 2United States;Czechia;Czech Republic;Canada;Spain;Poland;Turkey;Romania;Russian Federation;Germany
16NCT04947579
(ClinicalTrials.gov)
August 25, 202123/6/2021A Study of CC-99677 in Participants With Active Ankylosing SpondylitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: CC-99677;Other: PlaceboCelgeneNULLTerminated18 Years65 YearsAll167Phase 2United States;China;Czechia;Germany;Poland;Romania;Spain;Turkey;Canada;Russian Federation
17ITMCTR2100005056
2021-07-192021-07-16Yunpi Yishen Tongdu for active ankylosing spondylitis: a prospective cohort studyYunpi Yishen Tongdu for active ankylosing spondylitis: a prospective cohort study ankylosing spondylitisNon-exposed group: Meloxicam tablets, once a day, one tablet at a time. According to the patient's condition, sulfasalazine tablets and other recommended anti-rheumatic drugs for the treatment of AS/SpA can be added.;Exposed group:On the basis of the non-exposure group, Yunpi Yishen Jiedu Tongdu granules were added. ;Zhejiang University of Traditional Chinese MedicineNULLPending1865BothNon-exposed group:125;Exposed group:125;N/AChina
18ChiCTR2100048756
2021-07-192021-07-16Yunpi Yishen Tongdu for active ankylosing spondylitis: a prospective cohort studyYunpi Yishen Tongdu for active ankylosing spondylitis: a prospective cohort study ankylosing spondylitisNon-exposed group: Meloxicam tablets, once a day, one tablet at a time. According to the patient's condition, sulfasalazine tablets and other recommended anti-rheumatic drugs for the treatment of AS/SpA can be added.;Exposed group:On the basis of the non-exposure group, Yunpi Yishen Jiedu Tongdu granules were added. ;Zhejiang University of Traditional Chinese MedicineNULLPending1865BothNon-exposed group:125;Exposed group:125;N/AChina
19EUCTR2020-004284-98-GR
(EUCTR)
15/07/202105/04/2021Secukinumab open label roll-over extension protocolAn open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
628Phase 4United States;Czechia;Greece;Spain;Guatemala;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Poland;Brazil;Malaysia;Belgium;Bulgaria;South Africa;Korea, Republic of
20EUCTR2019-004108-37-DE
(EUCTR)
09/07/202118/02/2021A study to determine how effective and safe the drug CC-99677 is for patients with active Ankylosing SpondylitisA Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: CC-99677 60mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Product Code: CC-99677 30mg Capsule
INN or Proposed INN: 146368
Other descriptive name: CC-99677
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
256Phase 2United States;Czechia;Czech Republic;Canada;Spain;Poland;Turkey;Romania;Russian Federation;Germany
21NCT04934059
(ClinicalTrials.gov)
July 1, 20218/6/2021Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis.Ankylosing SpondylitisDrug: Yuxuebi tablet;Drug: Placebo tabletChina Resources Sanjiu Medical & Pharmaceutical Co., Ltd.NULLNot yet recruiting18 Years65 YearsAll60Phase 4China
22NCT04840485
(ClinicalTrials.gov)
June 9, 20217/4/2021Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: SHR-1314;Drug: PlaceboSuzhou Suncadia Biopharmaceuticals Co., Ltd.NULLRecruiting18 YearsN/AAll529Phase 2/Phase 3China
23NCT04885751
(ClinicalTrials.gov)
June 1, 202126/4/2021Compare the Effect of Eupatilin and Rebamipide on the Prevention of GastroenteropathyCompare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot StudyRheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis;Other Musculoskeletal Disorder;Gastric Ulcer;Enteritis;NSAID-Associated Gastropathy;NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced EnteropathyDrug: Eupatilin;Drug: RebamipideSeoul National University Boramae HospitalDong-A ST Co., Ltd.Not yet recruiting19 Years70 YearsAll50Phase 4NULL
24NCT04527380
(ClinicalTrials.gov)
April 13, 202124/8/2020A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic ArthritisJuvenile Psoriatic Arthritis;Enthesitis Related ArthritisDrug: Ixekizumab;Drug: AdalimumabEli Lilly and CompanyNULLRecruiting2 Years17 YearsAll100Phase 3Argentina;Belgium;Czechia;Denmark;France;Germany;Italy;Mexico;Netherlands;Spain;Switzerland;United Kingdom
25ChiCTR2100044377
2021-04-012021-03-17Study on the curative effect of spectrum therapy instrument in ankylosing spondylitisStudy on the curative effect of spectrum therapy instrument in ankylosing spondylitis Ankylosing spondylitisAS Spectrum Treatment Group:None;The First Affiliated Hospital of Suzhou UniversityNULLRecruiting1974BothAS Spectrum Treatment Group:40;China
26ChiCTR2100044284
2021-03-092021-03-14Study on the effect of ginger with different thickness on the treatment of ankylosing spondylitisEffect of Fuyang and Dumoxibustion on Ankylosing Spondylitis of Kidney-Yang Deficiency and on TNF-a and IL-6 Ankylosing spondylitisThe control group:Celecoxib 20mg once daily;Ginger tube moxibustion group:Oral celecoxib 20mg once a day, combined with Du moxibustion (ginger thickness 3cm);Thick ginger du moxibustion group:Oral celecoxib 20mg once a day, combined with Du moxibustion (ginger 5cm thickness);Affiliated Hospital of Nanjing University of Chinese MedicineNULLRecruiting1860MaleThe control group:20;Ginger tube moxibustion group:20;Thick ginger du moxibustion group:20;China
27ITMCTR2100004572
2021-03-092021-03-14Study on the effect of ginger with different thickness on the treatment of ankylosing spondylitisEffect of Fuyang and Dumoxibustion on Ankylosing Spondylitis of Kidney-Yang Deficiency and on TNF-a and IL-6 Ankylosing spondylitisThick ginger du moxibustion group:Oral celecoxib 20mg once a day, combined with Du moxibustion (ginger 5cm thickness);The control group:Celecoxib 20mg once daily;Ginger tube moxibustion group:Oral celecoxib 20mg once a day, combined with Du moxibustion (ginger thickness 3cm);Affiliated Hospital of Nanjing University of Chinese MedicineNULLRecruiting1860MaleThick ginger du moxibustion group:20;The control group:20;Ginger tube moxibustion group:20;China
28ChiCTR2100044045
2021-03-082021-03-09Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases including rheumatoid arthritis, ankylosing spondylitis and psoriasisReal-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases including rheumatoid arthritis, ankylosing spondylitis and psoriasis Immune-Mediated Inflammatory DiseasesCase series:Adalimumab;Mianyang Hospital of Traditional Chinese MedicineNULLRecruitingBothCase series:50;Phase 4China
29EUCTR2018-000681-10-CZ
(EUCTR)
25/02/202122/12/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Belgium;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Switzerland
30NCT04839315
(ClinicalTrials.gov)
February 15, 20215/4/2021COVID-19 Vaccination in Rheumatic Disease PatientsImmunological Consequences of COVID-19 Vaccination in Patients With Rheumatic DiseasesSystemic Lupus Erythematosus;Sjogren's Syndrome;Inflammatory Myositis;Psoriatic Arthritis;Gout;Ankylosing Spondylitis;Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis);OsteoarthritisBiological: mRNA COVD19 vaccineMayo ClinicNULLTerminated18 YearsN/AAll58Early Phase 1United States
31ChiCTR2100043171
2021-02-082021-02-07Efficacy and safety of iguratimod combined with NSAIDs in the treatment of AXSPA /AS in the real worldEfficacy and safety of iguratimod combined with NSAIDs in the treatment of AXSPA /AS in the real world Axial spinal arthritis/ankylosing spondylitistest group:Iguratimod;Qilu Hospital of Shandong UniversityNULLRecruitingMaletest group:278;Phase 4China
32EUCTR2020-004284-98-BG
(EUCTR)
05/02/202129/01/2021Secukinumab open label roll-over extension protocolAn open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
628Phase 4United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Poland;Belgium;Brazil;Malaysia;Bulgaria;South Africa;Germany;Sweden;Korea, Republic of
33ChiCTR2100042477
2021-02-012021-01-22High-flow nasal cannula oxygen during endotracheal intubation in patients with ankylosing spondylitis: a prospective, single-arm studyHigh-flow nasal cannula oxygen during endotracheal intubation in patients with ankylosing spondylitis : a prospective, single-arm study ankylosing spondylitisGroup HFNC:Nasal high-flow oxygen inhalation before tracheal intubation;Shenzhen Second People's HospitalNULLPending1850BothGroup HFNC:30;China
34ChiCTR2100042789
2021-02-012021-01-28Clinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western MedicineClinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western Medicine Ankylosing Spondylitisintegrated traditional Chinese and western medicine:Bushen-Qiangdu-Zhilv decoction and Celecoxib Capsules;Guangdong Provincial Hospital of Chinese MedicineNULLRecruiting1870Bothintegrated traditional Chinese and western medicine:27;China
35ITMCTR2100004334
2021-02-012021-01-28Clinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western MedicineClinical Study on the Treatment of Ankylosing Spondylitis with Integrated Traditional Chinese and Western Medicine Ankylosing Spondylitisintegrated traditional Chinese and western medicine:Bushen-Qiangdu-Zhilv decoction and Celecoxib Capsules;Guangdong Provincial Hospital of Chinese MedicineNULLRecruiting1870Bothintegrated traditional Chinese and western medicine:27;China
36EUCTR2018-000681-10-IT
(EUCTR)
23/12/202024/05/2021An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis - TALZ Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
Product Name: Ixekizumab
Product Code: [TALTZ]
INN or Proposed INN: ixekizumab
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: Adalimumab
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
37EUCTR2018-000681-10-DK
(EUCTR)
14/12/202031/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
38JPRN-JapicCTI-205414
12/12/202018/08/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Nonradiographic axial spondyloarthritis / Ankylosing spondylitisIntervention name : UCB4940
INN of the intervention : bimekizumab
Dosage And administration of the intervention : 160mg administered by sc injection
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., Ltd.NULLrecruiting18BOTH30Phase 3Japan, Asia except Japan, North America, Europe
39EUCTR2019-001684-77-HU
(EUCTR)
07/12/202008/12/2020A trial to test whether BI 730357 is effective in patients with active ankylosing spondylitisA 12-weeks Phase II, randomized, double-blind, placebocontrolled, parallel-group, proof-of-concept trial of BI 730357 in patients with active ankylosing spondylitis axial spondyloarthritis
MedDRA version: 21.1;Level: LLT;Classification code 10041672;Term: Spondylitis ankylosing;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Physical Phenomena [G01]
Product Code: BI 730357
INN or Proposed INN: BI 730357
Other descriptive name: BI 730357
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Czechia;Hungary;Spain;Belgium;Ukraine;Romania;Georgia;Germany;Moldova, Republic of;Korea, Republic of
40NCT04507659
(ClinicalTrials.gov)
December 1, 20204/8/2020Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing SpondylitisA Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase ? Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Jaktinib Hydrochloride Tablets;Drug: PlaceboSuzhou Zelgen Biopharmaceuticals Co.,LtdNULLRecruiting18 Years65 YearsAll105Phase 2China
41NCT04483687
(ClinicalTrials.gov)
December 202020/7/2020Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug TherapyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug TherapyAnkylosing SpondylitisDrug: Filgotinib;Drug: Placebo to Match FilgotinibGilead SciencesGalapagos NVWithdrawn18 YearsN/AAll0Phase 3NULL
42NCT04483700
(ClinicalTrials.gov)
December 202020/7/2020Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug TherapyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug TherapyAnkylosing SpondylitisDrug: Filgotinib;Drug: Placebo to Match FilgotinibGilead SciencesGalapagos NVWithdrawn18 YearsN/AAll0Phase 3NULL
43EUCTR2018-000681-10-GB
(EUCTR)
24/11/202011/09/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;Switzerland;Italy;United Kingdom
44EUCTR2018-000681-10-DE
(EUCTR)
23/11/202007/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
45NCT04481139
(ClinicalTrials.gov)
October 14, 202015/7/2020A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis SubjectsAnkylosing SpondylitisDrug: SHR0302;Drug: SHR0302 placeboJiangsu HengRui Medicine Co., Ltd.NULLActive, not recruiting18 Years75 YearsAll504Phase 2/Phase 3China
46EUCTR2019-004163-47-GB
(EUCTR)
08/10/202005/08/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
47ChiCTR2000038277
2020-10-012020-09-15The factor analysis of curative effect of AS and the indications analysis of Long-snake moxibustion based on content analysis methodThe factor analysis of curative effect of AS and the indications analysis of Long-snake moxibustion based on content analysis method Ankylosing spondylitisTrial Group:Long-snake moxibustion;Control Group:Sulfasalazine Enteric-coated Tablets;Nanchang Hongdu Hospital of TCMNULLRecruiting1850BothTrial Group:20;Control Group:20;N/AChina
48ITMCTR2000004152
2020-10-012020-09-15The factor analysis of curative effect of AS and the indications analysis of Long-snake moxibustion based on content analysis methodThe factor analysis of curative effect of AS and the indications analysis of Long-snake moxibustion based on content analysis method Ankylosing spondylitisTrial Group:Long-snake moxibustion;Control Group:Sulfasalazine Enteric-coated Tablets;Nanchang Hongdu Hospital of TCMNULLRecruiting1850BothTrial Group:20;Control Group:20;N/AChina
49NCT04507763
(ClinicalTrials.gov)
August 1, 202027/7/2020Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing SpondylitisClinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Ankylosing Spondylitis (AS) With EtanerceptAnkylosing SpondylitisDrug: EtanerceptPfizerNULLCompleted18 YearsN/AAll1Iraq
50EUCTR2019-004163-47-DE
(EUCTR)
23/07/202027/04/2020A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
51EUCTR2019-003229-12-DE
(EUCTR)
30/06/202005/12/2019Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
52EUCTR2019-001177-90-SE
(EUCTR)
30/06/202017/12/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of
53EUCTR2019-004163-47-HU
(EUCTR)
16/06/202001/04/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Spain;Turkey;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
54NCT04436640
(ClinicalTrials.gov)
June 16, 202015/6/2020A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial SpondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial SpondyloarthritisAxial Spondyloarthritis;Ankylosing Spondylitis;r-axSpa;Nr-axSpaDrug: BimekizumabUCB Biopharma SRLNULLActive, not recruiting18 YearsN/AAll485Phase 3United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom
55EUCTR2019-003229-12-IT
(EUCTR)
09/06/202024/05/2021Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis - na Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: [ABT-494]
INN or Proposed INN: UPADACITINIB
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLNot RecruitingFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
56EUCTR2019-004163-47-BG
(EUCTR)
04/06/202014/05/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
57EUCTR2019-004163-47-CZ
(EUCTR)
26/05/202007/04/2020A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritisA Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
485Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
58EUCTR2019-001177-90-IT
(EUCTR)
06/05/202019/05/2021Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of
59EUCTR2019-001177-90-BG
(EUCTR)
07/04/202012/02/2020Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Philippines;Czechia;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Malaysia;Belgium;Brazil;Bulgaria;Sweden;Korea, Republic of
60EUCTR2019-003229-12-ES
(EUCTR)
10/03/202006/03/2020Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;China;Japan;New Zealand;Korea, Republic of
61EUCTR2019-003229-12-GB
(EUCTR)
02/03/202016/12/2019Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
62EUCTR2019-001177-90-CZ
(EUCTR)
20/02/202019/12/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Belgium;Brazil;Malaysia;Poland;Bulgaria;Korea, Republic of;Sweden
63EUCTR2019-003229-12-HU
(EUCTR)
27/01/202002/12/2019Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
64EUCTR2019-001177-90-GR
(EUCTR)
23/01/202013/11/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United States;Czechia;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of
65EUCTR2019-001177-90-BE
(EUCTR)
21/01/202022/10/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of;United States;Czechia;Philippines;Greece
66EUCTR2019-003229-12-SK
(EUCTR)
14/01/202015/11/2019Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1;Level: PT;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Rinvoq
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
67NCT04156620
(ClinicalTrials.gov)
December 11, 20198/10/2019Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpAA Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritisAnkylosing SpondylitisDrug: Secukinumab;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll527Phase 3United States;Belgium;Brazil;Bulgaria;Colombia;Czechia;Greece;Guatemala;India;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Russian Federation;Sweden;Thailand;Turkey
68NCT04205851
(ClinicalTrials.gov)
November 12, 20194/12/2019Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing SpondylitisAn Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Gimsilumab in Healthy Subjects and Subjects With Ankylosing SpondylitisInflammation;Rheumatic DiseasesDrug: KIN-1901;Drug: PlaceboKinevant Sciences GmbHNULLCompleted18 Years75 YearsAll36Phase 1Canada
69NCT04077957
(ClinicalTrials.gov)
October 7, 20191/9/2019Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDsTreat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled StudyAnkylosing Spondylitis;SpondyloarthritisDrug: Methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine;Drug: Etanercept (50mg per week, for 4 weeks);Drug: Etanercept (50mg per week, for 2 weeks);Drug: Etanercept (50mg per week)Nanfang Hospital of Southern Medical UniversityNULLNot yet recruiting18 Years50 YearsAll100Phase 4China
70JPRN-JapicCTI-194860
30/9/201916/07/2019A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : UCB4940
INN of the intervention : bimekizumab
Dosage And administration of the intervention : 160mg administered by sc injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., LtdNULLcomplete18BOTH15Phase 3Japan, Asia except Japan, North America
71ChiCTR1900025749
2019-09-202019-09-07Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled StudyTreat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs, a Prospective Randomized Controlled Study Ankylosing SpondylitisExperimental:conventional synthetic Disease modifying anti-rheumatic drugs(csDMARDs);Experimental:Etanercept (Anbainuo 50mg per week, for 4 weeks);Experimental:Etanercept (Anbainuo 50mg per week, for 2 weeks);Positive Control:Etanercept (Anbainuo 50mg per week, for 12 weeks);Positive Control:Etanercept (Anbainuo 50mg per 10 days, for 12 weeks);Positive Control:Etanercept (Anbainuo 25mg per week, for 12 weeks);Positive Control:Etanercept (Anbainuo 25mg per 2 weeks, for 12 weeks);Nanfang Hospital of Southern Medical UniversityNULLPending1850BothExperimental:50;Experimental:50;Experimental:50;Positive Control:50;Positive Control:50;Positive Control:50;Positive Control:50;N/AChina
72ChiCTR1900025635
2019-09-022019-09-03Three-dimensional kinematics and hip biomechanical study of hip joint replacement in ankylosing spondylitisThree-dimensional kinematics and hip biomechanical study of hip joint replacement in ankylosing spondylitis ankylosing spondylitisCase series:unilateral THA was implanted on the same side with the same design and type of uncemented prosthesis, ankylosing spondylitis;99 Huaihai Road West, Xuzhou, Jiangsu, ChinaNULLPending1875BothCase series:20;N/AChina
73EUCTR2018-003933-14-BE
(EUCTR)
19/07/201924/04/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: no
Male: yes
250Phase 2Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
74EUCTR2017-003065-95-NL
(EUCTR)
03/07/201925/07/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Netherlands;Germany;China;Japan
75EUCTR2017-003065-95-GB
(EUCTR)
01/07/201929/03/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis.A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
76NCT04943237
(ClinicalTrials.gov)
July 1, 201919/6/2021Anti-TNF Therapy and Nerve Conduction Studies in Ankylosing SpondylitisAnti-TNF Therapy and Nerve Conduction Studies in Patients With Ankylosing SpondylitisAnti - TNF Therapy;Ankylosing Spondylitis;NeuropathyDrug: Anti-TNF agents;Drug: Conventional therapy users for the last 5 yearsIstanbul Physical Medicine Rehabilitation Training and Research HospitalNULLCompleted20 Years65 YearsAll60Turkey
77EUCTR2018-003933-14-BG
(EUCTR)
21/06/201927/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Czechia;Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
78EUCTR2017-003065-95-BG
(EUCTR)
19/06/201910/05/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
79EUCTR2017-003065-95-CZ
(EUCTR)
17/06/201904/06/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
80EUCTR2017-003065-95-FR
(EUCTR)
11/06/201921/05/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan
81EUCTR2017-003065-95-DE
(EUCTR)
11/06/201904/02/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
82EUCTR2018-003933-14-CZ
(EUCTR)
28/05/201929/04/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of
83EUCTR2018-003933-14-LV
(EUCTR)
27/05/201907/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of
84EUCTR2018-003933-14-ES
(EUCTR)
30/04/201921/05/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
85EUCTR2017-003065-95-ES
(EUCTR)
29/04/201921/05/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
86NCT03928743
(ClinicalTrials.gov)
April 25, 201923/4/2019A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bimekizumab;Other: PlaceboUCB Biopharma SRLNULLCompleted18 YearsN/AAll332Phase 3United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom
87EUCTR2017-003065-95-BE
(EUCTR)
19/04/201926/02/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
88EUCTR2017-003065-95-HU
(EUCTR)
16/04/201925/03/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
89EUCTR2018-003933-14-EE
(EUCTR)
09/04/201914/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia
90ChiCTR2000034142
2019-04-012020-06-26Study on TCM Syndrome Classification and Diagnosis and Treatment of Ankylosing Spondylitis by MetabolomicsStudy on TCM Syndrome Classification and Diagnosis and Treatment of Ankylosing Spondylitis by Metabolomics Ankylosing spondylitisExperimental group:Take Chinese medicine preparation Wen-Shen Juan-Bi-Tang orally;Experimental group 2:Take Chinese medicine preparation modified Wen-Shen Juan-Bi-Tang orally;NSAID:Take celecoxib orally;Jiangsu Province Hospital of TCMNULLPending2570BothExperimental group:40;Experimental group 2:40;NSAID:40;N/AChina
91ITMCTR2000003433
2019-04-012020-06-26Study on TCM Syndrome Classification and Diagnosis and Treatment of Ankylosing Spondylitis by MetabolomicsStudy on TCM Syndrome Classification and Diagnosis and Treatment of Ankylosing Spondylitis by Metabolomics Ankylosing spondylitisExperimental group:Take Chinese medicine preparation Wen-Shen Juan-Bi-Tang orally;Experimental group 2:Take Chinese medicine preparation modified Wen-Shen Juan-Bi-Tang orally;NSAID:Take celecoxib orally;Jiangsu Province Hospital of TCMNULLPending2570BothExperimental group:40;Experimental group 2:40;NSAID:40;N/AChina
92EUCTR2017-000679-10-GR
(EUCTR)
05/03/201919/12/2018A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
93NCT03733925
(ClinicalTrials.gov)
January 7, 20195/11/2018A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic ArthritisA Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of Golimumab (a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously) in the Treatment of Indian Patients With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic ArthritisSpondylitis, Ankylosing;Arthritis, PsoriaticDrug: GolimumabJohnson & Johnson Private LimitedNULLCompleted18 YearsN/AAll100Phase 4India
94NCT03839862
(ClinicalTrials.gov)
January 1, 201911/2/2019Faecal Analyses in Spondyloarthritis TherapyFaecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.Spondyloarthropathies;Ankylosing SpondylitisDrug: TNF-inhibitionRegion SkaneNULLRecruiting18 YearsN/AAll50Sweden
95ChiCTR1800019227
2018-11-262018-10-31A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Iguratimod in Chinese patients with active spondyloarthritis(SpA)/ankylosing spondylitis(AS)A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Iguratimod in Chinese patients with active spondyloarthritis(SpA)/ankylosing spondylitis spondyloarthritis(SpA)/ankylosing spondylitis(AS)spondyloarthritis(SpA)/ankylosing spondylitis(AS):Iguratimod;Control group:Placebo;PLA General HospitalNULLPending1665Bothspondyloarthritis(SpA)/ankylosing spondylitis(AS):72;Control group:36;China
96JPRN-JapicCTI-184106
07/11/201811/09/2018Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (SURPASS)A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : Secukinumab
INN of the intervention : Secukinumab
Dosage And administration of the intervention : Secukinumab 150mg or 300mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Control intervention name : GP2017 (adalimumab biosimilar)
INN of the control intervention : Adalimumab
Dosage And administration of the control intervention : GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102
Novartis Pharma K.K.NULLcomplete18BOTH15Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
97EUCTR2017-004226-15-DK
(EUCTR)
26/10/201805/01/2018 Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Cannabidiol tablet 10 mg
Other descriptive name: CANNABIDIOL
Product Name: Dronabinol capsule 2.5. mg
INN or Proposed INN: DRONABINOL
King Christian 10th Hospital for RheumatologyNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark
98EUCTR2017-000679-10-SK
(EUCTR)
24/10/201802/10/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
99EUCTR2018-000226-58-DE
(EUCTR)
18/10/201816/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
100EUCTR2018-001060-35-ES
(EUCTR)
19/09/201817/07/2018A long-term extension study to investigate the safety and effectiveness of Tildrakizumab in patients with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed other studies with TildrakizumabA Multiple-Dose, Long-Term Extension Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis who have previously completed studies with Tildrakizumab Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
MedDRA version: 20.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tildrakizumab 100 mg/ml
Product Code: MK-3222
INN or Proposed INN: Tildrakizumab
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
Sun Pharma Global FZENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
540Phase 3United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation
101EUCTR2018-001060-35-HU
(EUCTR)
29/08/201821/06/2018A long-term extension study to investigate the safety of Tildrakizumab in patients with Psoricatic Arthritis who have previously completed other studies with TildrakizumabA Long-Term Extension Study to Demonstrate Safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab Psoriatic Arthritis (PsA)
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Ilumetri
Product Name: Tildrakizumab 100 mg/ml
Product Code: MK-3222
INN or Proposed INN: Tildrakizumab
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
Sun Pharma Global FZENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
286Phase 3United States;Hungary;Mexico;Argentina;Poland;Spain;Ukraine;Russian Federation
102NCT03636984
(ClinicalTrials.gov)
August 24, 201813/8/2018Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real WorldEfficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational StudyRheumatoid Arthritis;Ankylosing SpondylitisDrug: recombinant TNF-a receptor: IgG Fc fusion proteinZhejiang Hisun Pharmaceutical Co. Ltd.NULLNot yet recruiting18 YearsN/AAll1000NULL
103EUCTR2018-000226-58-GB
(EUCTR)
13/08/201815/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
104EUCTR2018-000226-58-BG
(EUCTR)
07/08/201831/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
105EUCTR2017-000957-37-NL
(EUCTR)
18/07/201831/10/2017Study to test the efficacy and safety of bimekizumab and certolizumab pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Netherlands;Moldova, Republic of
106EUCTR2017-000679-10-PT
(EUCTR)
16/07/201815/01/2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
107EUCTR2018-000226-58-FR
(EUCTR)
12/07/201823/04/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
108EUCTR2018-000226-58-CZ
(EUCTR)
09/07/201804/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
109EUCTR2018-000226-58-AT
(EUCTR)
06/07/201814/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
110EUCTR2018-000226-58-ES
(EUCTR)
04/07/201809/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
111EUCTR2018-000226-58-HU
(EUCTR)
26/06/201826/04/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
112EUCTR2017-000679-10-PL
(EUCTR)
19/06/201828/03/2018Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
113EUCTR2017-000679-10-NL
(EUCTR)
07/06/201818/12/2017A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
114NCT03502616
(ClinicalTrials.gov)
June 7, 201811/4/2018Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)Ankylosing SpondylitisDrug: TofacitinibPfizerNULLCompleted18 YearsN/AAll270Phase 3United States;Australia;Bulgaria;Canada;China;Czechia;France;Hungary;Israel;Korea, Republic of;Poland;Russian Federation;Turkey;Ukraine;Slovakia;Spain;Taiwan
115ChiCTR-INR-17013574
2018-06-012017-11-28Clinical Study on Treating Ankylosing Spondylitis with Chinese Herbal Decoction Zhitongzhu DecoctionClinical Study on Treating Ankylosing Spondylitis with Chinese Herbal Decoction Zhitongzhu Decoction Ankylosing spondylitiscontrol group :Leflunomide;Intervention group :Chinese herbalshentongzhuyudecoction;The First Affiliated Hospital of Heilongjiang Chinese Medicine ColledgeNULLPending1625Malecontrol group :40;Intervention group :40;China
116EUCTR2017-004850-40-NL
(EUCTR)
25/04/201828/02/2018Detection and monitoring of effects of biological therapy on bone formation in patients with Bechterew's disease or psoriatic arthritis with the use of a Positron Emission Tomography (PET) scan.[18F]Fluoride PET-CT imaging for detection and monitoring of bone formation in spondyloarthritis - [18F]Fluoride PET in SpA Spondyloarthritis (ankylosing spondylitis and psoriatic arthritis);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: [18F]FluorideVU Medical Center, department of RheumatologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 4Netherlands
117EUCTR2017-000431-14-HR
(EUCTR)
06/04/201819/04/2018A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
118NCT03350815
(ClinicalTrials.gov)
March 13, 201831/10/2017Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Parallel-group, Multicenter Study of Secukinumab to Compare 300 mg and 150 mg at Week 52 in Patients With Ankylosing Spondylitis Who Are Randomized to Dose Escalation After Not Achieving Inactive Disease During an Initial 16 Weeks of Open-label Treatment With Secukinumab 150 mg (ASLeap)Ankylosing SpondylitisDrug: 150 mg open-label secukinumab;Drug: 150 mg double-blinded secukinumab;Drug: 300 mg double-blinded secukinumabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll322Phase 4United States
119NCT03473665
(ClinicalTrials.gov)
March 1, 201813/3/2018Non-Steroidal Anti-inflammatory Drugs in Axial SpondyloarthritisNon-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis: a Pilot StudyAnkylosing Spondylitis;Axial SpondyloarthritisDrug: Indomethacin;Drug: Diclofenac;Drug: Meloxicam;Drug: CelecoxibColumbia UniversityNULLTerminated18 YearsN/AAll9Phase 4United States
120EUCTR2017-000431-14-DE
(EUCTR)
21/02/201831/07/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
121NCT03447704
(ClinicalTrials.gov)
February 9, 201821/2/2018International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing SpondylitisAn International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: BCD-085;Other: placeboBiocadNULLActive, not recruiting18 Years65 YearsAll228Phase 3Russian Federation
122EUCTR2017-000431-14-SE
(EUCTR)
24/01/201820/12/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
123EUCTR2017-001002-15-DE
(EUCTR)
22/01/201820/09/2017A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - BE AGILE 2 Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB BIOPHARMA SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany
124EUCTR2017-000679-10-FR
(EUCTR)
22/01/201822/09/2017A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
125EUCTR2017-004037-93-DK
(EUCTR)
17/01/201807/11/2017TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study)TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study) Axial spondyloarthritis and ankylosing spondylitis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Cosentyx
Product Name: Cosentyx
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Afdeling for Rygkirurgi, Led- og Bindevævssygdomme ; Rigshospitalet - GlostrupNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88Phase 4Denmark
126EUCTR2017-000679-10-CZ
(EUCTR)
10/01/201825/09/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Israel;Chile;Russian Federation;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
127EUCTR2017-000431-14-NL
(EUCTR)
05/01/201822/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
128ChiCTR-DDD-17014196
2018-01-012017-12-28HLA-B27 tested by different methods and comparisonHLA-B27 tested by different methods and comparison Ankylosing spondylitisGold Standard:Detect HLA-B27 by cytometry;Index test:SSP and SSO;Dalian Blood CenterNULLRecruiting590BothTarget condition:200;Difficult condition:0China
129EUCTR2017-000431-14-GB
(EUCTR)
28/12/201708/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
130EUCTR2017-001970-41-DK
(EUCTR)
21/12/201715/09/2017 Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation) Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis
MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
INN or Proposed INN: ABATACEPT
Trade Name: Orencia
Product Name: Abatacept
Product Code: L04AA24
INN or Proposed INN: ABATACEPT
Trade Name: Humira
Product Name: Adalimumab
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: L04AB05
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Enbrel
Product Name: Etanercept
Product Code: L04AB01
INN or Proposed INN: ETANERCEPT
MD, PhD Salome KristensenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesDenmark
131EUCTR2017-000679-10-DE
(EUCTR)
18/12/201724/08/2017A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
132EUCTR2017-001002-15-BG
(EUCTR)
18/12/201726/09/2017A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - BE AGILE 2 Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Russian Federation;Bulgaria;Germany
133EUCTR2017-000679-10-FI
(EUCTR)
18/12/201705/10/2017A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
134NCT03322618
(ClinicalTrials.gov)
December 18, 201717/10/2017Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood SamplesEvaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 (Monoclonal Antibody IPH4102 Targeting KIR3DL2) in Blood Samples Taken From Patients With Axial Spondyloarthritis and Healthy VolunteersAxial Spondyloarthritis (axSpA);Ankylosing Spondylitis (AS)Biological: blood samplesAssistance Publique Hopitaux De MarseilleNULLCompleted18 YearsN/AAll24N/AFrance
135NCT03411798
(ClinicalTrials.gov)
December 15, 201714/12/2017Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate ASSequential Application of Yisaipu® and Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Treating Mild-to-Moderate Ankylosing Spondylitis: the Mid-term Follow-up ResultAnkylosing SpondylitisDrug: Yisaipu®Nanfang Hospital of Southern Medical UniversityNULLCompletedN/AN/AAll76Phase 4China
136EUCTR2017-000431-14-CZ
(EUCTR)
13/12/201708/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Portugal;United States;Finland;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
137NCT03259074
(ClinicalTrials.gov)
November 30, 201721/8/2017Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: Secukinumab;Biological: GP2017 (adalimumab biosimilar)Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll861Phase 3United States;Argentina;Australia;Belgium;Canada;Chile;Colombia;Czechia;Denmark;Finland;France;Germany;Greece;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;United Kingdom;Monaco
138NCT03355573
(ClinicalTrials.gov)
November 28, 201722/11/2017A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: BimekizumabUCB Biopharma SRLNULLCompleted18 YearsN/AAll256Phase 2United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine
139EUCTR2017-000679-10-DK
(EUCTR)
23/11/201725/10/2017A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Hyrimoz
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
837Phase 3United States;Portugal;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;Japan
140EUCTR2017-000679-10-ES
(EUCTR)
23/11/201718/09/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
837Phase 3Portugal;United States;Philippines;Taiwan;Slovakia;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany
141EUCTR2017-000679-10-GB
(EUCTR)
16/11/201708/08/2017Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis - SURPASS Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Product Name: adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
837 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Philippines;Taiwan;Slovakia;Greece;Spain;Russian Federation;Chile;Israel;Colombia;France;Australia;Denmark;Peru;Netherlands;Korea, Republic of;Finland;Turkey;Monaco;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan
142EUCTR2017-000431-14-BE
(EUCTR)
15/11/201730/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
143EUCTR2017-000957-37-DE
(EUCTR)
15/11/201714/07/2017Study to test the efficacy and safety of bimekizumab andcertolizumab pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Netherlands;United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Moldova, Republic of
144EUCTR2017-000431-14-PL
(EUCTR)
15/11/201720/10/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3New Zealand;Portugal;United States;Finland;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Japan;Sweden;Korea, Republic of
145EUCTR2017-001002-15-ES
(EUCTR)
13/11/201702/10/2017A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2Hungary;Spain;Germany
146EUCTR2017-000431-14-FR
(EUCTR)
13/11/201719/07/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
228Phase 2;Phase 3Portugal;United States;Finland;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
147NCT02980705
(ClinicalTrials.gov)
November 6, 201730/11/2016Efficacy and Safety Study of SUNPG1622A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloarthritisActive Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisDrug: SUNPG1622 I dose;Drug: Placebo doseSun Pharmaceutical Industries LimitedNULLTerminated18 YearsN/AAll180Phase 2United States;Hungary;Poland;Spain
148NCT03357471
(ClinicalTrials.gov)
November 3, 201723/11/2017Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseModerate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's DiseaseDrug: e-DeviceUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll70Phase 3United States
149NCT03329885
(ClinicalTrials.gov)
November 2, 201731/10/2017A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious PsoriasisA Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe PsoriasisRheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic SteatohepatitisDrug: BMS-986251;Other: PlaceboBristol-Myers SquibbNULLTerminated18 Years70 YearsAll38Phase 1/Phase 2Netherlands
150EUCTR2017-001002-15-CZ
(EUCTR)
01/11/201729/08/2017A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2Hungary;Czech Republic;Spain;Bulgaria;Germany
151EUCTR2017-001002-15-HU
(EUCTR)
25/10/201729/08/2017A Study to Evaluate the Long Term Safety and Efficacy ofBimekizumab in Subjects with Ankylosing SpondylitisA Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects with Ankylosing Spondylitis - To assess the long term safety & tolerability of bimekizumab in subjects with ankylosing spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: BIMEKIZUMAB
UCB BIOSCIENCES GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
285Phase 2Hungary
152NCT03178487
(ClinicalTrials.gov)
October 24, 20175/6/2017A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing SpondylitisAnkylosing Spondylitis (AS)Drug: Upadacitinib;Drug: PlaceboAbbVieNULLCompleted18 YearsN/AAll187Phase 2United States;Australia;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Spain;Sweden;United Kingdom
153EUCTR2017-000431-14-PT
(EUCTR)
09/10/201709/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
154EUCTR2017-000957-37-GR
(EUCTR)
05/10/201713/09/2017Study to test the efficacy and safety of Bimekizumab andCertolizumab Pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of
155NCT03215277
(ClinicalTrials.gov)
October 4, 20175/7/2017A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing SpondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bimekizumab;Drug: Certolizumab pegol;Other: PlaceboUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll76Phase 2United States;Czechia;Germany;Greece;Moldova, Republic of;Netherlands;Poland;Russian Federation;Australia
156EUCTR2017-000431-14-ES
(EUCTR)
02/10/201708/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
228Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
157NCT04480359
(ClinicalTrials.gov)
October 1, 201716/7/2020Bawei Shenqi Pill in the Treatment of Ankylosing SpondylitisThe Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bawei Shenqi Pill;Drug: Bawei Shenqi Pill placebo;Drug: MeloxicamShanghai University of Traditional Chinese MedicineNULLRecruiting18 Years70 YearsAll80Phase 2/Phase 3China
158EUCTR2017-000431-14-HU
(EUCTR)
26/09/201704/09/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
228Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
159EUCTR2017-000431-14-DK
(EUCTR)
25/09/201725/07/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
228Phase 2;Phase 3Portugal;United States;Finland;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
160EUCTR2017-000957-37-CZ
(EUCTR)
25/09/201712/07/2017Study to test the efficacy and safety of bimekizumab and certolizumab pegol in patients with active ankylosing spondylitis A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of
161EUCTR2017-000431-14-FI
(EUCTR)
06/09/201701/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
162EUCTR2016-001102-42-GB
(EUCTR)
24/05/201722/03/2017 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
285 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
163NCT03140657
(ClinicalTrials.gov)
April 29, 201728/4/2017The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis PatientsThe Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Ankylosing Spondylitis PatientsAnkylosing SpondylitisDrug: Nanocurcumin;Drug: PlaceboTabriz University of Medical SciencesNULLCompleted23 Years46 YearsAll24Phase 2Iran, Islamic Republic of
164EUCTR2016-003636-21-BE
(EUCTR)
12/04/201713/02/2017A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Estonia;Czech Republic;Poland;Spain;Belgium;Ukraine;Bulgaria;Germany
165EUCTR2016-003636-21-BG
(EUCTR)
11/04/201703/02/2017A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
166EUCTR2016-003936-19-ES
(EUCTR)
04/04/201710/02/2017A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisA Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Ankylosing spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tildrakizumab
Product Code: MK-3222
INN or Proposed INN: Tildrakizumab
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
SUN Pharmaceuticals Global FZENULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom
167EUCTR2016-003936-19-HU
(EUCTR)
20/03/201706/01/2017A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisA Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Ankylosing spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Tildrakizumab
Product Code: MK-3222
INN or Proposed INN: Tildrakizumab
Other descriptive name: Anti-Human Interleukin-23 Monoclonal Antibody
SUN Pharmaceuticals Global FZENULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom
168NCT03117270
(ClinicalTrials.gov)
March 7, 201730/3/2017A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: filgotinib;Drug: Placebo Oral TabletGalapagos NVNULLCompleted18 YearsN/AAll116Phase 2Belgium;Bulgaria;Czechia;Estonia;Poland;Spain;Ukraine
169EUCTR2016-003636-21-CZ
(EUCTR)
14/02/201719/12/2016A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noEstonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
170EUCTR2016-001102-42-BG
(EUCTR)
10/02/201705/01/2017 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
285 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
171EUCTR2016-001102-42-DE
(EUCTR)
09/02/201716/11/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
172EUCTR2016-003636-21-ES
(EUCTR)
01/02/201722/12/2016A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis ankylosing spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
173EUCTR2016-003636-21-EE
(EUCTR)
26/01/201708/12/2016A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis ankylosing spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Czech Republic;Estonia;Spain;Poland;Belgium;Ukraine;Bulgaria;Germany
174EUCTR2016-001102-42-ES
(EUCTR)
28/12/201627/10/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
175EUCTR2016-001102-42-CZ
(EUCTR)
16/12/201603/11/2016 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
285 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
176NCT04135508
(ClinicalTrials.gov)
December 13, 201617/10/2019A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and HumiraA Multicenter, Randomized, Double-Blind, Phase III Clinical Trial Parallel Controlled With Humira to Evaluate the Efficacy and Safety of BAT1406 Injection in the Treatment of Ankylosing SpondylitisAnkylosing SpondylitisDrug: BAT1406;Drug: HumiraBio-Thera SolutionsNULLCompleted16 Years65 YearsAll554Phase 3NULL
177EUCTR2016-001102-42-HU
(EUCTR)
21/11/201628/09/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: bimekizumab
Product Code: UCB4940
INN or Proposed INN: bimekizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Czech Republic;Hungary;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
178NCT02896127
(ClinicalTrials.gov)
October 18, 20164/5/2016Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes, to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing SpondylitisAnkylosing SpondyloarthritisDrug: Secukinumab;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll458Phase 3China;Czechia;Korea, Republic of;United Kingdom;Czech Republic
179EUCTR2016-002061-54-IT
(EUCTR)
13/10/201615/11/2018Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINULLNot RecruitingFemale: yes
Male: yes
250Phase 4Italy
180NCT02963506
(ClinicalTrials.gov)
October 201610/11/2016A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisOther: Placebo;Drug: BimekizumabUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll303Phase 2United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic
181NCT02893254
(ClinicalTrials.gov)
September 22, 201629/8/2016Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Parallel-controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Monoclonal Antibody Against Human Tumor Necrosis Factor-a (IBI303) Compared to Adalimumab in Patients With Active Ankylosing SpondylitisASDrug: IBI303;Drug: AdalimumabInnovent Biologics (Suzhou) Co. Ltd.NULLCompleted18 Years65 YearsAll438Phase 3NULL
182EUCTR2015-005021-39-CZ
(EUCTR)
15/09/201614/07/2016Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5 Ankylosing Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
454 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Korea, Democratic People's Republic of;China;United Kingdom
183NCT02763111
(ClinicalTrials.gov)
September 20163/4/2016Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing SpondylitisInternational Multi-center Comparative Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: BCD-085;Other: PlaceboBiocadNULLCompleted18 Years65 YearsAll88Phase 2NULL
184NCT02758782
(ClinicalTrials.gov)
September 201620/4/2016NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing SpondylitisCOmparison of the Effect of Treatment With NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine Over Two Years in Patients With ankyLosing Spondylitis: a Randomized Controlled Multicentre TrialAnkylosing SpondylitisBiological: Golimumab;Drug: CelecoxibCharite University, Berlin, GermanyNULLCompleted18 YearsN/AAll156Phase 4Germany
185EUCTR2015-005021-39-GB
(EUCTR)
04/08/201612/07/2016Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5 Ankylosing Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
454 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Korea, Democratic People's Republic of;China;United Kingdom
186EUCTR2016-000615-33-DE
(EUCTR)
29/07/201606/07/2016Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis: a randomized controlled multicentre trial (CONSUL)Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis: a randomized controlled multicentre trial (CONSUL) - CONSUL ankylosing spondylitis (AS)
MedDRA version: 21.1;Level: LLT;Classification code 10041672;Term: Spondylitis ankylosing;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10048398;Term: Spondylitis ankylosing aggravated;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Simponi
Trade Name: Celebrex
Charite UniversitaetsmedizinNULLNot RecruitingFemale: yes
Male: yes
170Phase 4Germany
187NCT03932006
(ClinicalTrials.gov)
June 30, 201626/4/2019A Multicenter,Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing SpondylitisA Multicenter,Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing SpondylitisAnkylosing SpondylitisDrug: Fengshigutong Capsule plus Imrecoxib;Drug: Fengshigutong Capsule;Drug: ImrecoxibSun Yat-sen UniversityNULLRecruiting18 Years65 YearsAll180Phase 4China
188NCT03557853
(ClinicalTrials.gov)
June 20165/6/2018Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With GolimumabA Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab)Ankylosing Spondylitis;CoxitisDrug: Golimumab InjectionMSD Pharmaceuticals LLCNULLUnknown status18 YearsN/AAll39Russian Federation
189NCT02763046
(ClinicalTrials.gov)
May 31, 20163/5/2016Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the NSAID-sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM)Ankylosing SpondylitisDrug: Secukinumab (AIN457) 150 mg s.c.;Drug: Placebo - Secukinumab (AIN457) 150 mg s.c.Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll211Phase 4Germany
190NCT02750800
(ClinicalTrials.gov)
April 7, 201613/4/2016Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUERheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative ColitisBiological: Adalimumab;Behavioral: AbbVie Care 2.0AbbVieNULLCompleted18 Years99 YearsAll427Hungary
191NCT02750592
(ClinicalTrials.gov)
March 22, 20164/4/2016Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing SpondylitisAn Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll30Phase 3Japan
192EUCTR2015-004575-74-DE
(EUCTR)
16/03/201618/02/2016Clinical study to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab in patients with ankylosing spondylitisA randomized, double-blind, placebo-controlled multicenter study of Secukinumab (AIN457) to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab over 16 weeks in patients with ankylosing spondylitis (ASTRUM) - ASTRUM Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGermany
193JPRN-JapicCTI-163241
01/3/2016An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing SpondylitisAn Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : AIN457
Dosage And administration of the intervention : secukinumab 150mg : Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.
Control intervention name : null
Novartis Pharma K.K.NULL18BOTH30Phase 3NULL
194EUCTR2015-001894-41-BG
(EUCTR)
12/02/201628/10/2015Multicenter study evaluating certolizumab pegol compared to placebo insubjects with axSpA without x-ray evidence of ASPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION. ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: CIMZIA certolizumab pegol 200 mg/ml solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Hungary;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria
195NCT02638896
(ClinicalTrials.gov)
January 201620/12/2015Dose Reduction of Etanercept in Patients With Ankylosing SpondylitisEfficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept (Half-Dose);Drug: etanercept (Full-Dose);Drug: Sulfasalazine;Drug: CelecoxibZhixiang HuangNULLNot yet recruiting18 Years45 YearsBoth100Phase 4NULL
196NCT02762812
(ClinicalTrials.gov)
January 20164/4/2016Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing SpondylitisInternational Multi-center Comparative Double-blind Randomized Clinical Trial to Evaluate Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Patients With Ankylosing SpondylitisAnkylosing SpondylitisBiological: BCD-055;Biological: Remicade®BiocadNULLCompleted18 Years65 YearsAll199Phase 3Russian Federation
197EUCTR2015-001894-41-CZ
(EUCTR)
20/11/201521/08/2015Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without x-ray evidence of ASPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION. ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: CIMZIA certolizumab pegol 200 mg/ml solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Hungary;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria
198NCT02809300
(ClinicalTrials.gov)
November 201520/6/2016Ankylosing Spondylitis and Antiphospholipid AntibodiesPrevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 PatientsAnkylosing SpondylarthritisBiological: blood collectionCHU de ReimsNULLRecruiting18 YearsN/ABoth80N/AFrance
199NCT02469753
(ClinicalTrials.gov)
October 23, 20159/6/2015Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic OutcomesInterest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic OutcomesAnkylosing SpondylitisDrug: NSAIDs;Drug: anti-TNFUniversity Hospital, BordeauxNULLActive, not recruiting18 YearsN/AAll188Phase 3France;Monaco
200EUCTR2015-001894-41-HU
(EUCTR)
16/10/201519/08/2015Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without X-ray evidence of ASPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION. ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
MedDRA version: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: CIMZIA certolizumab pegol 200 mg/ml solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Czech Republic;Hungary;Canada;Poland;Australia;Russian Federation;Bulgaria
201EUCTR2015-002284-42-FI
(EUCTR)
18/09/201528/08/2015The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activitINTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specifyTrade Name: Enbrel
Product Name: etanercept
Trade Name: Humira
Product Name: adalimumab
Trade Name: Cimzia
Product Name: certolizumab pegol
Trade Name: Simponi
Product Name: golimumab
Trade Name: Remicade
Product Name: infliximab
READENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1650Phase 1Finland
202EUCTR2014-004887-39-PL
(EUCTR)
08/08/201507/07/2015A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid ArthritisAn Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., LtdNULLNot RecruitingFemale: yes
Male: yes
Poland
203ChiCTR-IPR-15006753
2015-08-012015-07-15A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of methotrexate in Chinese patients with active non-radiographic axial spondyloarthritis(SpA)/ankylosing spondylitis.A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of methotrexate in Chinese patients with active non-radiographic axial spondyloarthritis(SpA)/ankylosing spondylitis. spondyloarthritis(SpA)/ankylosing spondylitis(AS)AS+peripheral arthritis:MTX;AS+peripheral arthritis:placebo;AS:MTX;AS:placebo;nr-axial SpA+peripheral arthritis:MTX;nr-axial SpA+peripheral arthritis:placebo;nr-xial SpA:MTX;nr-xial SpA:placebo;Department of rheumatology of the Chinese PLA General HospitalNULLPendingBothAS+peripheral arthritis:77;AS+peripheral arthritis:77;AS:77;AS:77;nr-axial SpA+peripheral arthritis:77;nr-axial SpA+peripheral arthritis:77;nr-xial SpA:77;nr-xial SpA:77;China
204EUCTR2013-005575-41-GB
(EUCTR)
28/07/201527/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
324 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;United Kingdom;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
205EUCTR2013-005575-41-BG
(EUCTR)
28/05/201518/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
206NCT03800797
(ClinicalTrials.gov)
May 25, 20157/1/2019Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing SpondylitisEfficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label StudyAnkylosing SpondylitisDrug: Loxoprofen sodium hydrogel patch;Drug: Loxoprofen sodium tabletSun Yat-sen UniversityNULLCompleted18 Years65 YearsAll70Phase 4China
207NCT02159053
(ClinicalTrials.gov)
May 18, 201528/2/201416-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: Secukinumab;Biological: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll350Phase 3United States;Australia;Austria;Bulgaria;Canada;Czechia;Denmark;Finland;Germany;Greece;Italy;Netherlands;Norway;Poland;Russian Federation;Slovakia;Spain;Switzerland;United Kingdom;Czech Republic;Mexico
208EUCTR2013-005575-41-ES
(EUCTR)
11/05/201503/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
324Phase 3Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;United States;Slovakia;Greece;Finland
209EUCTR2013-005575-41-PL
(EUCTR)
04/05/201519/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
210NCT02492217
(ClinicalTrials.gov)
May 20153/7/2015Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) a Agent's Efficacy in Ankylosing Spondylitis PatientsBiomarkers Identification of Anti-TNF a Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass SpectrometryAnkylosing SpondylitisDrug: AdalimumabUniversidade Nova de LisboaNULLCompleted18 Years75 YearsAll69Phase 4Portugal
211EUCTR2013-005575-41-NO
(EUCTR)
29/04/201523/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Netherlands;Germany;Norway
212EUCTR2013-005575-41-DE
(EUCTR)
27/04/201503/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
213EUCTR2013-005575-41-SK
(EUCTR)
16/04/201513/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
214EUCTR2013-005575-41-NL
(EUCTR)
13/04/201510/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands
215EUCTR2013-005575-41-DK
(EUCTR)
13/04/201525/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany
216NCT02293681
(ClinicalTrials.gov)
April 10, 201514/11/2014An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip InvolvementA Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip InvolvementSpondylitis, AnkylosingDrug: Infliximab;Drug: NSAIDs;Drug: DMARDsJanssen Research & Development, LLCNULLTerminated16 Years40 YearsAll76N/AChina
217EUCTR2013-005575-41-FI
(EUCTR)
08/04/201520/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
218EUCTR2013-005575-41-GR
(EUCTR)
02/04/201529/04/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
219EUCTR2013-005575-41-CZ
(EUCTR)
31/03/201530/01/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
220EUCTR2013-005575-41-AT
(EUCTR)
23/03/201505/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
221EUCTR2013-005575-41-IT
(EUCTR)
05/03/201511/03/201616-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.1;Level: LLT;Classification code 10002555;Term: Ankles swollen;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
NOVARTIS FARMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
324Phase 3Slovakia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway
222NCT02359903
(ClinicalTrials.gov)
February 201530/1/2015Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing SpondylitisInternational Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Infliximab (BCD-055);Drug: Infliximab (Remicade)BiocadNULLCompleted18 Years65 YearsAll90Phase 1Belarus;Russian Federation
223NCT02333383
(ClinicalTrials.gov)
December 31, 20146/1/2015Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) PatientsA Prospective, Mono-Country, Multi-Center Study to Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis Patients on Adalimumab TherapyAnkylosing SpondylitisDrug: AdalimumabAbbVieNULLCompleted19 Years100 YearsAll201Korea, Republic of
224EUCTR2014-000241-74-DE
(EUCTR)
30/12/201401/10/2014A Study of Golimumab in Participants with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Ankylosing Spondylitis - GO - ALIVE Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: golimumab
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Human anti-TNFa monoclonal antibody
Janssen Biologics, BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Poland;Brazil;Ukraine;Romania;Australia;Russian Federation;Germany;Korea, Republic of
225NCT02328027
(ClinicalTrials.gov)
December 11, 201418/12/201499mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)A Phase I-IIa Study of Safety, Tolerance, Pharmacokinetics, Dosimetry and Benefice of Early Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 in Patients With Rheumatoid Arthritis or Ankylosing SpondylitisRheumatoid Arthritis;Ankylosing SpondylitisDrug: 99mTc-rhAnnexin V-128Advanced Accelerator ApplicationsNULLTerminated18 YearsN/AAll16Phase 1/Phase 2Switzerland
226ChiCTR1800014846
2014-12-012018-02-09Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplastyEffect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty: A prospective randomized double-blind controlled trial osteonecrosis of the femoral head, femoral neck fracture, developmental dysplasia of hip, osteoarthritis, rheumatoid arthritis or ankylosing spondylitisExperiment group:preoperative intravenous parecoxib sodium and postoperative intravenous parecoxib sodium and patient-controlled analgesia;Control Group:preoperative intravenous pure 0.9% saline and postoperative intravenous parecoxib sodium and patient-controlled analgesia;Peking Union Medical College HospitalNULLCompletedBothExperiment group:50;Control Group:50;China
227EUCTR2011-005689-39-SK
(EUCTR)
24/09/201407/07/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
228NCT01934933
(ClinicalTrials.gov)
September 24, 201417/8/2013Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing SpondylitisA Multi-center, Open Label, Random Clinical Trial of Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: celebrex;Drug: Enbrel;Drug: Enbrel plus CelebrexSun Yat-sen UniversityNULLCompleted18 Years65 YearsAll150Phase 4China
229EUCTR2013-004406-25-PT
(EUCTR)
19/09/201421/02/2014Biomarkers identification of efficacy in Ankylosing SpondylitisBiomarkers identification of anti-TNF a agent’s efficacy in Ankylosing Spondylitis patients using a transcriptome analysis and mass spectrometry Ankylosing Spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Faculdade de Ciências Médicas da Universidade Nova de LisboaNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal
230NCT02186873
(ClinicalTrials.gov)
September 3, 20148/7/2014A Study of Golimumab in Participants With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Placebo;Drug: GolimumabJanssen Research & Development, LLCNULLCompleted18 YearsN/AAll208Phase 3United States;Australia;Canada;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Ukraine;Brazil;Romania
231EUCTR2011-005689-39-NL
(EUCTR)
01/09/201423/06/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Spain;Poland;Russian Federation;Germany;Netherlands;Korea, Republic of
232EUCTR2014-002056-40-NO
(EUCTR)
12/08/201413/06/2014A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasisA RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Diakonhjemmet Hospital ASNULLNot RecruitingFemale: yes
Male: yes
500Phase 4Norway
233NCT02202850
(ClinicalTrials.gov)
August 12, 201423/7/2014Defining Remission With Etanercept in AS in Real Life Clinical PracticeDefining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Ankylosing Spondylitis Patients Treated With Etanercept (Enbrel (Registered))Ankylosing SpondylitisDrug: etanerceptPfizerNULLCompleted18 YearsN/AAll84Belgium
234EUCTR2013-003812-30-NL
(EUCTR)
21/07/201426/05/2014A multicentre study to measure the transfer of Cimzia from women to infants via the placentaA MULTICENTER POSTMARKETING STUDY TO EVALUATETHE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL INPREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA®(CERTOLIZUMAB PEGOL) Rheumatoid ArthritisAxial spondyloarthritisPsoriatic arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 17.0;Classification code 10037160;Term: Psoriatic arthritis;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cimzia
Product Name: Certolizumab pegol / CIMZIA
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biosciences Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 1France;United States;Germany;Netherlands;Switzerland
235NCT01870284
(ClinicalTrials.gov)
July 20143/6/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Ixekizumab;Drug: Placebo;Drug: AdalimumabEli Lilly and CompanyNULLWithdrawn18 YearsN/ABoth0Phase 3United States;Argentina;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
236EUCTR2013-005013-13-PL
(EUCTR)
25/06/201431/03/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of
237EUCTR2013-001090-24-NO
(EUCTR)
29/04/201407/03/201416-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Germany;Norway;United Kingdom;Sweden
238EUCTR2013-005013-13-BG
(EUCTR)
28/04/201423/04/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Phase 3Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
239EUCTR2013-005013-13-LT
(EUCTR)
08/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
240NCT04582084
(ClinicalTrials.gov)
April 4, 20143/10/2020Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune ArthritisAssessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance StudyRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: EtanerceptAryoGen Pharmed Co.NULLCompleted18 YearsN/AAll583Iran, Islamic Republic of
241EUCTR2013-005013-13-CZ
(EUCTR)
03/04/201413/02/2014A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira®
Product Name: Humira®
INN or Proposed INN: ADALIMUMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
490Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina
242EUCTR2013-001090-24-GB
(EUCTR)
26/03/201431/12/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
243EUCTR2013-003666-13-DE
(EUCTR)
25/03/201401/11/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 18.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
212Phase 2France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of
244EUCTR2013-003666-13-NL
(EUCTR)
07/03/201403/01/2014BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 17.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer-Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
255Phase 2France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Germany;Netherlands;Italy;Korea, Republic of
245NCT04345458
(ClinicalTrials.gov)
March 6, 20143/4/2020Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing SpondylitisSafety and Efficacy of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis on the Basis of NSAID Therapy: A Multicenter Randomized, Double-blind, Parallel Group Phase III TrialAnkylosing SpondylitisDrug: prefilled liquid etanercept(Yisaipu);Drug: lyophilized etanercept powder(Yisaipu)Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.NULLCompleted18 Years65 YearsAll640Phase 3China
246EUCTR2013-003666-13-BE
(EUCTR)
28/02/201413/12/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 18.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Other descriptive name: BI 655066
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
212Phase 2France;United States;Hong Kong;Taiwan;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of
247EUCTR2013-001090-24-GR
(EUCTR)
25/02/201409/12/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
248EUCTR2013-001090-24-BE
(EUCTR)
13/02/201414/01/201416-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3United Kingdom;Sweden;United States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Norway;Germany
249EUCTR2013-001090-24-PT
(EUCTR)
23/01/201414/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
250EUCTR2013-001089-40-BE
(EUCTR)
23/01/201402/12/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 18.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab 150 mg/1 ml Solution for injection
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab 75 mg/0.5 ml Solution for injection
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
251EUCTR2011-005689-39-DE
(EUCTR)
20/01/201424/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
252NCT02008916
(ClinicalTrials.gov)
January 14, 20148/12/201316-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis PatientsA Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Secukinumab;Drug: Placebo secukinumabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll226Phase 3United States;Belgium;Czechia;Germany;Greece;Mexico;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;Norway;Sweden
253EUCTR2013-003666-13-IT
(EUCTR)
09/01/201411/11/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. Ankylosing Spondylitis
MedDRA version: 16.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
INN or Proposed INN: N.A.
Other descriptive name: BI 655066
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Taiwan;Hong Kong;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of
254EUCTR2013-001090-24-DE
(EUCTR)
08/01/201424/10/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 18.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
255EUCTR2013-002860-19-NL
(EUCTR)
07/01/201415/08/2013Cardiovascular risk in patients with Ankylosing SpondylitisThe risk of cardiovascular disease in Ankylosing Spondylitis; A Single Center Cross-Sectional Study Evaluating The Association Between Inflammation In Ankylosing Spondylitis And Vascular Inflammation - AS risk Ankylosing SpondylitisAtherosclerotic cardiovascular disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Atorvastatin
Product Name: Atorvastatin
Product Code: 5057732
INN or Proposed INN: ATORVASTATIN
Other descriptive name: atorvastatin
AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
256EUCTR2013-001089-40-BG
(EUCTR)
07/01/201421/11/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
274Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
257EUCTR2013-001090-24-CZ
(EUCTR)
30/12/201308/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
258EUCTR2013-001090-24-ES
(EUCTR)
26/12/201312/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
259EUCTR2013-003666-13-ES
(EUCTR)
26/12/201324/10/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 16.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Taiwan;Hong Kong;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of
260EUCTR2013-003666-13-FI
(EUCTR)
13/12/201331/10/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 16.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Hong Kong;Taiwan;Finland;Spain;Belgium;Germany;Netherlands;Italy;Korea, Republic of
261EUCTR2013-001089-40-DE
(EUCTR)
20/11/201307/08/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457, 150 mg
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457, 75 mg
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
274Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
262NCT01863732
(ClinicalTrials.gov)
November 6, 201323/5/2013Extension in AS: Sustainability of Benefits, Safety and TolerabilityAn Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: Secukinumab;Other: Placebo (Pbo)Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll274Phase 3United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom
263EUCTR2011-002325-22-BE
(EUCTR)
28/10/201309/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;South Africa;Netherlands;Germany
264EUCTR2011-002325-22-ES
(EUCTR)
28/10/201308/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
265EUCTR2011-002325-22-DE
(EUCTR)
25/10/201309/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
266EUCTR2013-001089-40-NL
(EUCTR)
24/10/201326/09/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
267EUCTR2013-001089-40-GB
(EUCTR)
03/10/201316/07/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
268EUCTR2011-002325-22-HU
(EUCTR)
26/09/201317/07/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
269EUCTR2011-002325-22-GB
(EUCTR)
26/09/201318/06/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot Recruiting Female: yes
Male: yes
408 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
270EUCTR2013-001089-40-IT
(EUCTR)
27/08/201302/07/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Farma SpANULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
271EUCTR2012-005026-30-HU
(EUCTR)
15/08/201320/02/2013A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel®
Product Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
498Phase 3Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
272EUCTR2011-005689-39-CZ
(EUCTR)
07/08/201323/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
273EUCTR2012-004939-23-FR
(EUCTR)
16/07/201328/10/2021Effet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosanteEffet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosante Cette étude portera sur une population avec une spondylarthrite ankylosante (SA) active nécessitant un traitement par adalimumab
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: METOJECT
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
CHRU de TOURSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 4France
274EUCTR2011-005689-39-HU
(EUCTR)
27/06/201322/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
275EUCTR2011-005689-39-ES
(EUCTR)
26/06/201324/06/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Taiwan;Hungary;Czech Republic;Slovakia;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
276EUCTR2012-005026-30-PL
(EUCTR)
17/05/201308/03/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel®
Product Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
277EUCTR2012-005026-30-CZ
(EUCTR)
15/05/201322/02/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel®
Product Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
278ChiCTR-TRC-13003449
2013-04-252013-06-07A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing SpondylitisA multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis Ankylosing SpondylitisThalidomide 150mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd, po., to the end;Thalidomide 100mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end;Control group:Placebo po.;The General Hospital of People's Liberation ArmyNULLCompleted1865BothThalidomide 150mg:80;Thalidomide 100mg:80;Control group:40;2 (Phase 2 study)China
279EUCTR2011-001555-37-EE
(EUCTR)
19/04/201319/03/2013Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 18.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
280EUCTR2010-019872-65-LT
(EUCTR)
11/04/201317/01/2013Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosyn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
281EUCTR2012-005026-30-BG
(EUCTR)
10/04/201305/03/2013A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate TherapyA Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel®
Product Name: Enbrel®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
596Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India
282NCT01786668
(ClinicalTrials.gov)
April 20136/2/2013Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing SpondylitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)Ankylosing SpondylitisDrug: Tofacitinib 2 mg;Drug: Tofacitinib 5 mg;Drug: Tofacitinib 10 mg;Drug: PlaceboPfizerNULLCompleted18 YearsN/AAll208Phase 2United States;Canada;Czech Republic;Germany;Hungary;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan
283NCT01895764
(ClinicalTrials.gov)
March 201324/4/2013Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)Ankylosing SpondylitisDrug: Adalimumab;Drug: MethotrexateUniversity Hospital, ToursNULLCompleted18 YearsN/ABoth110Phase 4France
284NCT02201043
(ClinicalTrials.gov)
February 201323/7/2014Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing SpondylitisAnkylosing SpondylitisDrug: Thalidomide 150mg;Drug: Thalidomide 100mg;Drug: PlaceboShanghai Pharmaceuticals Holding Co., LtdNULLCompleted18 Years65 YearsBoth197Phase 2China
285NCT01965132
(ClinicalTrials.gov)
January 1, 201311/10/2013Korean College of Rheumatology Biologics RegistryKorean College of Rheumatology Biologics RegistryRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: Biologic DMARDSeoul National University HospitalNULLRecruiting18 YearsN/AAll7000Korea, Republic of
286NCT01389388
(ClinicalTrials.gov)
January 201316/4/2010Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint DiseaseCholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint DiseasesCarotid Artery Plaque;Ankylosing Spondylitis;Rheumatoid ArthritisDrug: RosuvastatinDiakonhjemmet HospitalNULLCompleted35 Years80 YearsBoth114N/ANorway
287EUCTR2012-000046-35-DE
(EUCTR)
20/12/201219/09/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
288EUCTR2011-001555-37-NL
(EUCTR)
05/12/201215/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Germany;Netherlands;Sweden
289EUCTR2011-001555-37-BG
(EUCTR)
14/11/201214/08/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;South Africa;Netherlands;Germany;Sweden
290EUCTR2012-000046-35-ES
(EUCTR)
13/11/201226/09/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 15.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
291EUCTR2012-000046-35-NL
(EUCTR)
30/10/201216/08/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3Italy;Czech Republic;Canada;Singapore;Netherlands;Germany;United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom
292NCT01649375
(ClinicalTrials.gov)
October 18, 201220/7/201216 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing SpondylitisAnklyosing SpondylitisDrug: Secukinumab (75 mg);Drug: Placebo;Drug: Secukinumab (150 mg)Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll219Phase 3United States;Austria;Canada;Czechia;Finland;Germany;Italy;Netherlands;Russian Federation;Singapore;Spain;Switzerland;United Kingdom;Czech Republic
293EUCTR2012-000046-35-FI
(EUCTR)
10/10/201228/08/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
294EUCTR2011-001555-37-DE
(EUCTR)
20/09/201208/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 18.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
295JPRN-UMIN000015297
2012/09/1901/10/2014The feasibility study of accelated infliximab infusion from initial administrationThe feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalNULLRecruiting20years-old70years-oldMale and Female54Phase 2Japan
296EUCTR2012-000046-35-GB
(EUCTR)
17/09/201220/07/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3Spain;United States;Finland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Singapore;Germany;Netherlands
297EUCTR2011-001555-37-GB
(EUCTR)
04/09/201216/04/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
298NCT01668004
(ClinicalTrials.gov)
September 3, 20121/8/2012The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)Open-Label, Phase 4 Study, Investigating the Incidence of Extra-Articular Manifestations in Subjects With Ankylosing Spondylitis Treated With Golimumab; Protocol No. MK-8259-012Ankylosing SpondylitisBiological: GolimumabMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll101Phase 4Netherlands
299EUCTR2011-001555-37-CZ
(EUCTR)
14/08/201230/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
300EUCTR2011-001555-37-SE
(EUCTR)
09/08/201229/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
301EUCTR2011-001555-37-SK
(EUCTR)
31/07/201215/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
302EUCTR2012-000046-35-IT
(EUCTR)
31/07/201202/08/2012A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Singapore;Netherlands;Germany
303EUCTR2012-002458-21-NL
(EUCTR)
23/07/201203/07/2012Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with GolimumabOpen-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab - GO-EASY Ankylosing Spondylitis(Bechterew disease)
MedDRA version: 14.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
MERCK SHARP & DOHME B.V.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4Netherlands
304EUCTR2011-001555-37-ES
(EUCTR)
23/07/201228/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
305EUCTR2011-001555-37-AT
(EUCTR)
03/07/201230/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
306EUCTR2011-001555-37-PL
(EUCTR)
30/06/201229/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
307EUCTR2011-001555-37-HU
(EUCTR)
13/06/201202/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
308EUCTR2011-001555-37-FR
(EUCTR)
06/06/201223/08/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
309JPRN-UMIN000007806
2012/06/0101/05/2012The feasibility study of accelated infliximab infusion during maintenance phaseThe feasibility study of accelated infliximab infusion during maintenance phase - The feasibility study of accelated infliximab infusion during maintenance phase patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.Chiba University HospitalNULLComplete: follow-up completeNot applicableNot applicableMale and Female54Phase 2Japan
310NCT01610947
(ClinicalTrials.gov)
May 14, 201224/5/2012Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease ActivityEffect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled TrialSpondyloarthritisDrug: Adalimumab, Etanercept, Golimumab or infliximabUniversity Hospital, MontpellierNULLCompleted18 YearsN/AAll398N/AFrance
311NCT01583374
(ClinicalTrials.gov)
May 2, 201220/4/2012Study of Apremilast to Treat Subjects With Active Ankylosing SpondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITISAnkylosing SpondyloarthritisDrug: Apremilast tablet 20 mg;Drug: Apremilast tablet 30 mg BID;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll490Phase 3United States;Australia;Austria;Bulgaria;Canada;Czechia;Estonia;France;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Slovakia;Spain;Sweden;United Kingdom;Czech Republic
312NCT03880968
(ClinicalTrials.gov)
March 1, 201212/3/2019Treat-to-Target Strategy With Etanercept for Ankylosing SpondylitisTreat-to-Target Strategy With Etanercept for Ankylosing Spondylitis: a Prospective, Randomized Multicentric Study on Disease Activity Guided Etanercept Tapering or DiscontinuationSpondylitis, AnkylosingDrug: tapering or discontinuation of etanerceptSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityShanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine;First Affiliated Hospital of Wenzhou Medical University;The First Hospital of Jiaxing;Shaoxing Second Hospital;Shanghai Jiao Tong University Affiliated Sixth People's Hospital;Ningbo Medical Center Lihuili Hospital;Wenzhou Central Hospital;Zhejiang Provincial People's Hospital;Shaoxing People's HospitalCompleted18 Years65 YearsAll311NULL
313NCT01709656
(ClinicalTrials.gov)
March 201210/10/2012A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing SpondylitisA Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing SpondylitisAnkylosing SpondylitisBiological: MSC;Drug: celecoxib, Celebrex®Sun Yat-sen UniversityNULLCompleted16 Years65 YearsBoth120N/AChina
314NCT01571206
(ClinicalTrials.gov)
March 201223/3/2012An Extension Study to Demonstrate the Equivalence of Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1Ankylosing SpondylitisBiological: InfliximabCelltrionNULLCompleted18 Years75 YearsBoth174Phase 1Korea, Republic of
315NCT02922192
(ClinicalTrials.gov)
January 1, 201228/9/2016Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive AnalysisIncidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive AnalysisRheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing SpondylitisDrug: TNF-a antagonists, non-TNFs, DMARD non-biologicsBiologics & Biosimilars Collective Intelligence ConsortiumHealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Kaiser Permanente;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta Pharmaceuticals, Inc.;Pfizer;University of PittsburghCompleted18 YearsN/AAll90360NULL
316EUCTR2010-024529-18-BE
(EUCTR)
16/12/201120/10/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
317EUCTR2010-024529-18-DE
(EUCTR)
28/11/201101/08/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
318EUCTR2010-024529-18-BG
(EUCTR)
14/11/201109/11/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
319NCT01517620
(ClinicalTrials.gov)
November 201115/1/2012Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF TherapyAnkylosing SpondylitisDrug: Total Glucosides Paeony CapsulesSun Yat-sen UniversityNULLCompleted16 Years65 YearsBoth38Phase 4China
320NCT01358175
(ClinicalTrials.gov)
October 201119/5/201116 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Secukinumab (75 mg);Drug: Secukinumab (150 mg);Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll371Phase 3United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom
321NCT01330901
(ClinicalTrials.gov)
October 20115/4/2011Ustekinumab for the Treatment of Patients With Active Ankylosing SpondylitisUsTekinumab for the Treatment Of Patients With Active Ankylosing Spondylitis (TOPAS) - a 28-week, Prospective, Open-label, Proof-of-concept StudyAnkylosing SpondylitisDrug: UstekinumabCharite University, Berlin, GermanyNULLCompleted18 YearsN/ABoth22Phase 2Germany
322EUCTR2010-024529-18-GB
(EUCTR)
02/08/201118/07/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE 1 Ankylosing spondylitis
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
323EUCTR2010-024529-18-IT
(EUCTR)
25/07/201129/12/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
350Taiwan;Mexico;Canada;Belgium;Turkey;Peru;Bulgaria;Russian Federation;Germany;United Kingdom;Italy
324EUCTR2011-000844-56-DE
(EUCTR)
12/07/201109/06/2011UsTekinumab for the treatment Of Patients with active Ankylosing SpondylitisUsTekinumab for the treatment Of Patients with active Ankylosing Spondylitis (TOPAS) – a 28-week, prospective, open-label, proof-of-concept study - TOPAS Ankylosing spondylitis
MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Stelara
Product Name: Ustekinumab
Charité Universitätsmedizin BerlinNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Germany
325ChiCTR-TRC-11001417
2011-06-012011-07-10clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitisclinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitis Ankylosing Spondylitis (AS)1:oral salicylazosulfapyridine and indomethacin;2:Mecenchymal Stem Cells(MSC) transplantation ;Sun Yat-sen Memorial Hospital of Sun Yat-sen UniversityNULLRecruitingBoth1:80;2:80;I+2 (Phase 1+Phase 2)China
326EUCTR2009-017443-34-BE
(EUCTR)
16/05/201108/10/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Phase 2;Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Bulgaria;Germany;Italy;United Kingdom
327EUCTR2010-019872-65-CZ
(EUCTR)
10/05/201103/03/2011Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
328EUCTR2010-019872-65-SK
(EUCTR)
02/05/201128/02/2011A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing SpondylitisA Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: ARCOXIA
Product Name: etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: naproxen
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom
329EUCTR2009-017488-40-BE
(EUCTR)
22/03/201101/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
330NCT01327638
(ClinicalTrials.gov)
February 15, 201111/3/2011Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis PatientsSpondylarthropathies; Spondylitis, AnkylosingDrug: etoricoxib;Drug: Other COX-2 inhibitor;Drug: nsNSAIDsOrganon and CoNULLCompleted16 YearsN/AAll21108NULL
331NCT01361542
(ClinicalTrials.gov)
February 201124/5/2011Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian PopulationEffect Of Anti TNF Alpha Therapy On Disease Activity And Bone Health, And Their Adverse Effects In Ankylosing Spondylitis In A North Indian PopulationAnkylosing SpondylitisDrug: anti TNF alpha agent;Drug: Anti TNF alpha therapyAll India Institute of Medical Sciences, New DelhiNULLCompleted18 Years55 YearsBoth24N/AIndia
332EUCTR2009-017443-34-DE
(EUCTR)
17/01/201102/09/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;United Kingdom;Germany;Belgium;Bulgaria;Spain;Italy;Lithuania
333EUCTR2010-019872-65-AT
(EUCTR)
14/01/201103/09/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
334EUCTR2010-019872-65-BE
(EUCTR)
11/01/201131/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 16.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany
335EUCTR2009-017443-34-BG
(EUCTR)
07/01/201124/11/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
336ChiCTR-TRC-11001193
2011-01-012011-02-22Tripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trialTripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trial ankylosing spondylitisTreatment group: tripterygium wilfordii tablets ;Control group:Placebo;Jiangsu Provincial Hospital of Traditional Chinese MedicineNULLCompleted1860BothTreatment group:66;Control group:22;China
337NCT01411215
(ClinicalTrials.gov)
January 201113/5/2011A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient DepartmentA Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology DepartmentRheumatoid Arthritis;Ankylosing SpondylitisDrug: EnbrelPfizerNULLTerminated18 YearsN/AAll160N/AChina
338NCT01420432
(ClinicalTrials.gov)
January 201111/8/2011Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Ankylosing Spondylitis (AS)Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat ASAnkylosing SpondylitisBiological: Human umbilical cord-derived MSCsShandong UniversityNULLRecruiting18 Years60 YearsBoth10Phase 1China
339EUCTR2009-016068-35-NL
(EUCTR)
15/12/201024/06/2010A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNA randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
340EUCTR2009-017488-40-ES
(EUCTR)
14/12/201006/10/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy. Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la seguridad y la reducción de los signos ysíntomas durante el tratamiento con tocilizumab (TCZ) en comparación con placebo en pacientes con espondilitis anquilosante que han tenido una respuesta insuficiente al tratamiento previo con un antagonista del TNF.A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy. Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la seguridad y la reducción de los signos ysíntomas durante el tratamiento con tocilizumab (TCZ) en comparación con placebo en pacientes con espondilitis anquilosante que han tenido una respuesta insuficiente al tratamiento previo con un antagonista del TNF. Ankylosing SpondylitisEspondilitis Anquilosante
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Czech Republic;Slovakia;Belgium;Spain;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
341EUCTR2009-017443-34-ES
(EUCTR)
14/12/201006/10/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy.Estudio en fase II/III ininterrumpido, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la reducción de los signos y síntomas y la inhibición de los daños estructurales durante el tratamiento con tocilizumab en comparación con placebo en pacientes con espondilitis anquilosante que no han respondido a los antiinflamatorios no esteroideos y no han recibido tratamiento previo con antagonistas del TNF.A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy.Estudio en fase II/III ininterrumpido, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la reducción de los signos y síntomas y la inhibición de los daños estructurales durante el tratamiento con tocilizumab en comparación con placebo en pacientes con espondilitis anquilosante que no han respondido a los antiinflamatorios no esteroideos y no han recibido tratamiento previo con antagonistas del TNF. Ankylosing Spondylitis (AS)Espondilitis anquilosante (EA)
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania
342EUCTR2009-017488-40-BG
(EUCTR)
08/12/201022/11/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
343NCT01793285
(ClinicalTrials.gov)
December 201030/1/2013An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical TrialRetrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study)Ankylosing SpondylitisDrug: ETANERCEPTPfizerNULLCompleted18 YearsN/AAll85N/ASpain
344EUCTR2010-019872-65-EE
(EUCTR)
29/11/201003/11/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;South Africa;Germany
345EUCTR2009-017488-40-DK
(EUCTR)
16/11/201016/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
346EUCTR2010-019872-65-HU
(EUCTR)
09/11/201010/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
347EUCTR2009-017488-40-LT
(EUCTR)
02/11/201019/08/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
348EUCTR2009-017443-34-LT
(EUCTR)
02/11/201018/08/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania
349EUCTR2009-017488-40-GB
(EUCTR)
01/11/201009/08/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
350EUCTR2009-017443-34-GB
(EUCTR)
01/11/201009/08/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
502 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
351EUCTR2009-017443-34-CZ
(EUCTR)
27/10/201029/09/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
352EUCTR2010-019872-65-FI
(EUCTR)
18/10/201030/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1300Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
353EUCTR2009-017488-40-DE
(EUCTR)
18/10/201002/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
354EUCTR2009-017488-40-CZ
(EUCTR)
12/10/201020/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
355NCT01220518
(ClinicalTrials.gov)
October 20104/10/2010Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)Randomized, Double-blind, Parallel-group, Phase 1 StudyAnkylosing SpondylitisDrug: InfliximabCelltrionNULLCompleted18 Years75 YearsBoth257Phase 1Korea, Republic of
356NCT01248793
(ClinicalTrials.gov)
October 201024/11/2010Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Placebo;Drug: Golimumab;Drug: Golimumab (placebo group)Centocor, Inc.NULLCompleted18 YearsN/AAll213Phase 3China
357NCT01212653
(ClinicalTrials.gov)
October 201030/9/2010Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS)Effect of Anti-TNF(Alpha)Treatment on Circulating Endothelial Progenitor Cells (EPCs) and Vascular Stiffness in ASAnkylosing Spondylitis(AS)Drug: Simponi;Other: 0.9ml sodium chlorideChinese University of Hong KongNULLCompleted18 Years75 YearsBoth50Phase 4China
358NCT01209689
(ClinicalTrials.gov)
October 201024/9/2010A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist TherapyA Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist TherapySpondylitis, AnkylosingDrug: Tocilizumab;Drug: PlaceboHoffmann-La RocheNULLTerminated18 YearsN/AAll113Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Lithuania;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom
359NCT01208207
(ClinicalTrials.gov)
September 27, 201022/9/2010A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Part I - etoricoxib 60 mg;Drug: Part I - etoricoxib 90 mg;Drug: Part I- naproxen 1000 mg;Drug: Part I - Placebo to naproxen 500 mg;Drug: Part II- etoricoxib 60 mg;Drug: Part II- etoricoxib 90 mg;Drug: Part II- naproxen 1000 mg;Drug: Part I - Placebo to etoricoxib 60 mg;Drug: Part I - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to etoricoxib 60 mg;Drug: Part II - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to naproxen 500 mgOrganon and CoNULLCompleted18 YearsN/AAll1015Phase 3Argentina;Austria;Belgium;Canada;Colombia;Czech Republic;Estonia;Finland;France;Germany;Hungary;India;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States
360EUCTR2009-017488-40-IT
(EUCTR)
22/09/201028/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy - NDA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy - ND Ankylosing Spondylitis
MedDRA version: 9.1;Level: LLT;Classification code 10002556
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;United Kingdom;Italy
361EUCTR2009-017443-34-IT
(EUCTR)
22/09/201028/09/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naìve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naìve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
362EUCTR2009-011591-30-GB
(EUCTR)
21/09/201020/10/2009An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 Ankylosing spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;Netherlands;United Kingdom
363EUCTR2009-017443-34-SK
(EUCTR)
13/09/201017/08/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
364EUCTR2009-017488-40-SK
(EUCTR)
13/09/201016/08/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
365EUCTR2010-019263-11-LT
(EUCTR)
06/09/201003/06/2010A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAINA multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: not applicable
Product Code: SAR153191
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
270Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
366NCT01091675
(ClinicalTrials.gov)
September 201022/3/2010Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to =2 NSAIDsAssessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis (AS) and Inadequate Response to =2 Nonsteroidal Antiinflammatory Drug (NSAID)Ankylosing SpondylitisDrug: EtoricoxibSpanish Foundation of RheumatologyNULLCompleted18 YearsN/AAll58Phase 3Spain
367NCT01209702
(ClinicalTrials.gov)
September 201024/9/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDsA Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDsSpondylitis, AnkylosingBiological: tocilizumab;Drug: PlaceboHoffmann-La RocheNULLTerminated18 YearsN/AAll306Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;France;Germany;India;Italy;Lithuania;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom;Mexico;Netherlands
368EUCTR2010-020913-10-GB
(EUCTR)
11/08/201023/07/2010An open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERSAn open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERS Ankylosing spondylitisTrade Name: Enbrel®
Product Name: Enbrel
INN or Proposed INN: Etanercept
Trade Name: Enbrel
Product Name: Enbrel
Norfolk & Norwich University Hospitals NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
369EUCTR2010-019263-11-FR
(EUCTR)
02/08/201014/06/2010A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
270Phase 3France;Hungary;Czech Republic;Spain;Belgium;Lithuania;Austria
370EUCTR2009-011719-19-CZ
(EUCTR)
20/07/201020/07/2010PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 14.1;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Italy;United Kingdom
371EUCTR2009-011719-19-DE
(EUCTR)
19/07/201017/02/2010N/APHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 18.1;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Netherlands;United States;United Kingdom
372EUCTR2010-019263-11-HU
(EUCTR)
14/07/201020/05/2010A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: SAR153191
Product Code: SAR153191
sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
270Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
373EUCTR2010-019263-11-BE
(EUCTR)
08/07/201013/04/2010A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAINA multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
270Phase 3France;Hungary;Czech Republic;Spain;Belgium;Lithuania;Austria
374EUCTR2009-011719-19-BE
(EUCTR)
02/07/201023/04/2010NAPHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 16.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 16.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;United Kingdom;Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Germany;Netherlands
375EUCTR2009-011719-19-NL
(EUCTR)
29/06/201006/05/2010PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 14.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Italy;United Kingdom
376EUCTR2010-019263-11-ES
(EUCTR)
28/06/201021/04/2010Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) Espondilitis Anquilosante__________________________Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
270Phase 3France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria
377EUCTR2010-019263-11-CZ
(EUCTR)
03/06/201019/04/2010A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAINA multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
270Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
378EUCTR2009-018085-35-DK
(EUCTR)
21/05/201005/05/2010Intestinal inflammation in ankylosing spondylitis assessed by stoll samples and endoscopy and the effects of adalimumab on inflammationIntestinal Inflammation in Ankylosing Spondylitis assessed by Fecal Calprotectin, Capsular Endoscopy and Colonoscopy and the effects of Adalimumab on mucosal healing - INTASAH Ankylosing spondylitis Inflammatory bowel disease
MedDRA version: 14.0;Level: PT;Classification code 10061371;Term: Spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Level: LLT;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10048398;Term: Spondylitis ankylosing aggravated;Classification code 10041671;Term: Spondylitis ankylopoietica;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10041673;Term: Spondylitis NOS;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Regionalhospital SilkeborgNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
379EUCTR2010-019263-11-AT
(EUCTR)
19/05/201013/04/2010A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAINA multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN Ankylosing Spondylitis
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
270Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania
380EUCTR2009-011591-30-NL
(EUCTR)
17/05/201018/11/2009Safety and tolerability of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitisAn open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 Ankylosing spondylitis
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United States;Germany;Netherlands;United Kingdom
381EUCTR2009-011719-19-HU
(EUCTR)
13/05/201012/04/2010N/APHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 16.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 16.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany;Netherlands
382EUCTR2009-011719-19-GB
(EUCTR)
13/05/201015/03/2010PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 14.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of CompaniesNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom
383ChiCTR-ONRC-10000858
2010-05-102010-04-28Research on safety tolerance and pharmacokinetics of oral muti-dose ThalidomideResearch on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide Ankylosing SpondylitisGroup A:Muti-dose Thalidomide;GroupB:Muti-dose Thalidomide and Diclofenac sodium enteric-coated tablets ;Chinese PLA General HospitalNULLCompleted1845BothGroup A:15;GroupB:12;I (Phase 1 study)China
384EUCTR2009-016068-35-DE
(EUCTR)
03/05/201011/12/2009A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNA randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Ankylosing Spondylitis
MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
385EUCTR2009-016068-35-FR
(EUCTR)
26/04/201014/12/2009A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNA randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany
386ChiCTR-TRC-11001274
2010-04-012011-01-28Integrated Traditional Chinese and Western medicine for ankylosing spondylitisintegrated Traditional Chinese and Western medicine for ankylosing spondylitis with Gan-shen deficiency and Moist Heat Arthralgia Spasm Syndrome type ankylosing spondylitis;M45.911B group:Qiangji Granule placebo, Sulfasalazine, Ibuprofen;C group:Qiangji Granule placebo, Sulfasalazine, Ibuprofen;School of Chinese Medicine Southern Medical UniversityNULLCompleted1860BothB group:120;C group:180;China
387NCT01313858
(ClinicalTrials.gov)
April 201010/3/2011A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing SpondylitisArthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, AnkylosingDrug: Simponi®;Drug: MethotrexateMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll1613N/AGermany
388NCT01060098
(ClinicalTrials.gov)
April 201029/1/2010T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF BlockadeT Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha AgentsRheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic ArthritisDrug: anti-TNF therapy (etanercept or adalimumab)Imperial College LondonNULLCompleted18 Years80 YearsAll48United Kingdom
389NCT01109940
(ClinicalTrials.gov)
April 201022/4/2010Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing SpondylitisAn Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Moderate to Severe Ankylosing SpondylitisAnkylosing SpondylitisBiological: AIN457ANovartis PharmaceuticalsNULLCompleted18 Years65 YearsBoth39Phase 2United States;Germany;Netherlands;United Kingdom
390EUCTR2009-011719-19-FR
(EUCTR)
29/03/201004/02/2010PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 12.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies
MedDRA version: 12.1;Classification code 10051265;Term: Spondyloarthropathy
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of CompaniesNULLNot RecruitingFemale: yes
Male: yes
500Phase 3France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom
391EUCTR2009-016068-35-CZ
(EUCTR)
25/03/201001/04/2010A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNA randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Austria;Lithuania
392EUCTR2009-016068-35-LT
(EUCTR)
23/03/201030/12/2009A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNA randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: not applicable
Product Code: SAR153191
Product Name: not applicable
Product Code: SAR153191
Product Name: not applicable
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
393EUCTR2009-016587-36-ES
(EUCTR)
15/03/201027/01/2010Artritis de cadera asociada a la EA. Eficacia y Seguridad del tratamiento precoz con Infliximab (Remicade®)Artritis de cadera asociada a la EA. Eficacia y Seguridad del tratamiento precoz con Infliximab (Remicade®) Espondilitis anquilosante
MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB
Schering Plough, S.ANULLNot RecruitingFemale: yes
Male: yes
70Spain
394EUCTR2009-011591-30-DE
(EUCTR)
03/03/201008/12/2009An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 Ankylosing spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Netherlands;Germany;United Kingdom
395EUCTR2009-016068-35-ES
(EUCTR)
22/02/201016/12/2009Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNEstudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Espondilitis anquilosante___________________________Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
396EUCTR2009-016068-35-BE
(EUCTR)
19/02/201030/11/2009A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNA randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany
397EUCTR2009-017309-12-ES
(EUCTR)
18/02/201018/12/2009Evaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINESEvaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINES Espondilitis Anquilosante
MedDRA version: 9;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: ARCOXIA 90 mg comprimidos recubiertos con película
INN or Proposed INN: ETORICOXIB
Other descriptive name: ETORICOXIB
FUNDACIÓN ESPAÑOLA DE REUMATOLOGÍA (FER)NULLNot RecruitingFemale: yes
Male: yes
Spain
398EUCTR2009-016068-35-AT
(EUCTR)
28/01/201011/01/2010A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNA randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
399EUCTR2009-016068-35-HU
(EUCTR)
25/01/201014/12/2009A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Ankylosing Spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany
400NCT01114880
(ClinicalTrials.gov)
January 20105/2/2010Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing SpondylitisA Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab;Other: placeboAbbottNULLCompleted18 Years65 YearsAll344Phase 3China
401ChiCTR-ONRC-11001846
2009-12-032011-12-28The research of immue state and current treatment in Ankylosing spondylitisThe research of immue state and current treatment in Ankylosing spondylitis Ankylosing spondylitisTraditional therapy group:DMARDs;biological agent group:biological agent;thalidomide group:thalidomide;Department of Clinical Immunology, Xijing Hospital, Fourth Military Medical UniversityNULLCompleted1865BothTraditional therapy group:500;biological agent group:500;thalidomide group:500;NULL
402EUCTR2009-012424-87-GB
(EUCTR)
26/11/200914/10/2009T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNFT cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.0;Classification code 10037160;Term: Psoriatic arthritis
MedDRA version: 12.0;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Enbrel
INN or Proposed INN: etanercept
Trade Name: Humira
INN or Proposed INN: adalimumab
Trade Name: Enbrel
INN or Proposed INN: etanercept
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Imperial College London South Kensington LondonNULLNot Recruiting Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
403EUCTR2009-015515-40-NL
(EUCTR)
20/11/200928/09/2009PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVASPREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVAS The diagnosis of Ankylosing Spondylitis (AS) requires radiographically proven sacroiliitis.Inflammation on MRI is a prognostic factor for the development of AS. The aim is the decrease of inflammation on MRI of the SI joint and/or spine by giving them, a short period, anti-TNF therapy. The study is designed as a randomized, double-blind, placebo-controlled trial. After inclusion patients are randomly assigned to the etanercept- or placebo-arm of the study in a 1:1 ratio during 16 weeks.Trade Name: EnbrelWyeth Pharmaceuticals B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Netherlands
404NCT01006681
(ClinicalTrials.gov)
November 200931/10/2009Vaccination Against Influenza H1N1 in Rheumatic DiseasesEfficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory DrugsInfluenza;Rheumatic DiseasesBiological: Focetria (Monovalent MF59-Adjuvanted vaccine)Tel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 Years65 YearsBoth400Phase 2NULL
405NCT02456363
(ClinicalTrials.gov)
November 200914/12/2014Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing SpondylitisAnti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis—A Registry ProjectAnkylosing SpondylitisBiological: TNF alpha;Drug: NSAIDs and sulfasalazineChung Shan Medical UniversityNULLRecruiting18 YearsN/ABoth300Phase 2Taiwan
406NCT01421303
(ClinicalTrials.gov)
October 200919/8/2011Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.Work Productivity In A Cohort Of Employed Ankylosing Spondylitis Patients Treated With EtanerceptAnkylosing SpondylitisDrug: EnbrelPfizerNULLCompleted18 YearsN/AAll80Belgium
407NCT01104987
(ClinicalTrials.gov)
October 200913/4/2010Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS), an Open Label Prospective TrialAnkylosing Spondylitis;OsteoporosisDrug: alendronateGöteborg UniversityNULLCompleted18 Years80 YearsBoth16Sweden
408NCT00844805
(ClinicalTrials.gov)
September 200913/2/2009Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis TrialAnkylosing Spondylitis;Axial SpondyloarthritisDrug: Infliximab;Drug: Placebo;Drug: NaproxenMerck Sharp & Dohme Corp.NULLCompleted18 Years48 YearsAll158Phase 3Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;United States
409NCT01077843
(ClinicalTrials.gov)
August 17, 200926/2/2010Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)A Nested Case-control Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in a Cohort of Patients With Ankylosing Spondylitis (AS) in the UK, France and GermanyAnkylosing SpondylitisDrug: Etoricoxib;Drug: Other Cox-2 inhibitors;Drug: Other Non-selective NSAIDs;Other: No anti-inflammatory treatmentOrganon and CoNULLCompletedN/AN/AAll27381NULL
410EUCTR2007-003096-39-IT
(EUCTR)
29/07/200927/03/2009Effects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CRESTEffects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CREST Ankylosing Spondylitis
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
WYETH LEDERLENULLNot RecruitingFemale: yes
Male: yes
Italy
411NCT00762463
(ClinicalTrials.gov)
July 200929/9/2008Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing SpondylitisA 6-Week, Randomized, Double-Blind, Parallel-Group Study To Evaluate The Symptomatic Effects And Safety Of Celecoxib 200mg QD Compared To Diclofenac 75mg SR QD In Chinese Patients With Ankylosing Spondylitis, With 6-Week Extension Phase Treatment On Celecoxib 400 Mg QD Or Maintaining Double-Blind Phase TherapyAnkylosing SpondylitisDrug: Celecoxib;Drug: Diclofenac SRPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 Years65 YearsAll240Phase 3China
412ChiCTR-ONRC-11001565
2009-06-012011-09-16research of genetic gene and immune state in Ankylosing Spondylitisresearch of genetic gene and immune state in ankylosing spondylitis Ankylosing SpondylitisAS patients:None;Healthy control:None;Department of Clinical Immunology, Xijing Hospital, Fourth Military Medical UniversityNULLCompleted1865BothAS patients:500;Healthy control:500;NULL
413EUCTR2008-006885-27-NL
(EUCTR)
21/04/200905/11/2008EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITISEFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10051265;Term: Spondyloarthropathy
Trade Name: Humira
Product Name: adalimumab
INN or Proposed INN: adalimumab
Other descriptive name: ADALIMUMAB
Clinical Immunology and RheumatologyNULLNot RecruitingFemale: yes
Male: yes
Netherlands
414NCT01081717
(ClinicalTrials.gov)
April 14, 20094/3/2010Golimumab Safety and Surveillance Program Using the Ingenix NHI DatabaseA Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological TreatmentsRheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing SpondylitisDrug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general populationJanssen Biotech, Inc.NULLCompletedN/A99 YearsAll1064United States
415EUCTR2008-004229-40-GB
(EUCTR)
09/03/200922/11/2010Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Ankylosing Spondylitis (AS) - START - Spondylitis Trial of Apremilast for better Rheumatic TherapyRandomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Ankylosing Spondylitis (AS) - START - Spondylitis Trial of Apremilast for better Rheumatic Therapy Ankylosing Spondylitis
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Imperial College LondonNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
416EUCTR2008-007510-30-PL
(EUCTR)
06/03/200903/02/2009A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPYA PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPY ANKYLOSING SPONDYLITIS
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: ARRY-371797Array BioPharma Inc.NULLNot RecruitingFemale: yes
Male: yes
168Phase 2Hungary;Poland
417NCT00809159
(ClinicalTrials.gov)
March 200916/12/2008Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing SpondylitisRandomized, Placebo Controlled Double Blind, Multi-center Phase II Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Moderate to Severe Ankylosing SpondylitisAnkylosing SpondylitisBiological: AIN457;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll60Phase 2United States;Germany;Netherlands;United Kingdom
418EUCTR2008-002631-33-NL
(EUCTR)
23/02/200917/09/2008Efficacy of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitisRandomized, double-blind, placebo-controlled, multi-center, phase II, proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 ankylosing spondylitis
MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;United Kingdom;Netherlands
419EUCTR2008-007510-30-HU
(EUCTR)
09/02/200929/12/2008A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPYA PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPY ANKYLOSING SPONDYLITIS
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: ARRY-371797Array BioPharma Inc.NULLNot RecruitingFemale: yes
Male: yes
126Phase 2Hungary;Poland
420EUCTR2008-002631-33-GB
(EUCTR)
14/01/200925/07/2008Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209 Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Germany;United Kingdom;Netherlands
421EUCTR2007-007637-39-DE
(EUCTR)
17/12/200815/04/2008Effects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2 - ENRADASEffects of NSAIDs on RAdiographic Damage in AS (ENRADAS) – a prospective randomised controlled trial - Amendment 2 - ENRADAS Ankylosing spondylitis patients (according to mod. New York criteria) who have have active disease at inclusion defined as BASDAI question 2 (related to back pain) >= 4 (VAS, range 0-10) without NSAID treatment and with a clinical indication for NSAID therapy based on signs and symptoms.
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Voltaren resinat
Product Name: Voltaren resinat
Product Code: not applicable
Charité - Campus MitteNULLNot RecruitingFemale: yes
Male: yes
174Phase 4Germany
422NCT00811499
(ClinicalTrials.gov)
December 16, 200817/12/2008A Study of ARRY-371797 in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: ARRY-371797, p38 inhibitor; oral;Drug: PlaceboPfizerNULLTerminated18 YearsN/AAll25Phase 2United States;Canada
423EUCTR2008-002631-33-DE
(EUCTR)
15/12/200820/08/2008Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United Kingdom;Germany;Netherlands
424NCT00889694
(ClinicalTrials.gov)
October 200827/4/2009Clinical Study of Tripterygium Capsule to Treat Early Ankylosing SpondylitisClinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical TrialEarly Ankylosing SpondylitisDrug: Tripterygium;Drug: Sulfasalazine;Drug: placeboSun Yat-sen UniversityNULLEnrolling by invitation18 Years65 YearsBoth80Phase 2/Phase 3NULL
425NCT00766402
(ClinicalTrials.gov)
October 20083/10/2008An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet®) vs. Diclofenac (Voltaren®) in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)Spondylitis, Ankylosing;PainDrug: Tramadol /acetaminophen;Drug: DiclofenacJohnson & Johnson Taiwan LtdNULLTerminated18 Years70 YearsBoth8Phase 4NULL
426NCT00715091
(ClinicalTrials.gov)
September 200814/7/2008Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing SpondylitisEffects of NSAIDs on RAdiographic Damage in Ankylosing Spondylitis (ENRADAS) - a Prospective Randomised Controlled TrialAnkylosing SpondylitisDrug: diclophenacCharite University, Berlin, GermanyNULLCompleted18 Years65 YearsBoth180Phase 4Germany
427NCT02489760
(ClinicalTrials.gov)
July 200827/6/2015Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch StudyEtanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch StudyAnkylosing SpondylitisBiological: Adalimumab;Biological: EtanerceptChung Shan Medical UniversityNULLActive, not recruiting18 Years70 YearsBoth30Phase 4Taiwan
428EUCTR2007-003358-27-DE
(EUCTR)
02/05/200821/11/2007Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira StudyPhase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study Juvenile ankylosing spondylitis
MedDRA version: 10;Level: LLT;Classification code 10002556;Term:
Trade Name: Humira®
INN or Proposed INN: adalimumab
Center of Pediatrics and Neonatology, Asklepios Clinic Sankt AugustinNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
429NCT01188655
(ClinicalTrials.gov)
May 200824/8/2010Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing SpondylitisObservational Non-Interventional Study With Enbrel in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: EnbrelPfizerNULLCompleted18 YearsN/AAll89N/ANULL
430EUCTR2006-001579-40-DK
(EUCTR)
16/04/200804/09/2007Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpAStudy of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA Spondyloarthropathies
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Remicade
INN or Proposed INN: infliximab
Schering-Plough FranceNULLNot RecruitingFemale: yes
Male: yes
120France;Hungary;Spain;Denmark
431JPRN-JapicCTI-080580
01/4/2008A Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing SpondylitisA Multi-Center, Open-Labeled Study of Adalimumab in Japanese Subjects with Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : Every other week,Subcutaneous, 40mg
Control intervention name : null
Abbott Japan Co., Ltd.Eisai Co., Ltd.15BOTH30Phase 3NULL
432EUCTR2006-002748-27-HU
(EUCTR)
01/04/200830/01/2008A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis Active, severe and advanced axial ankylosing spondylitis
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
433NCT00647517
(ClinicalTrials.gov)
March 200826/3/2008Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing SpondylitisChung Shan Medical University Hospital, TaiwanAnkylosing SpondylitisDrug: UltracetChung Shan Medical UniversityNULLCompleted18 Years65 YearsBoth60Phase 4Taiwan
434NCT01072058
(ClinicalTrials.gov)
February 200818/2/2010Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerProspective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF BlockerArthritis, Rheumatoid;Spondylitis, AnkylosingDrug: TNF blockers (infliximab, adalimumab, etanercept)University of Sao PauloNULLActive, not recruiting18 Years70 YearsBoth100Phase 4Brazil
435NCT00936143
(ClinicalTrials.gov)
January 20087/7/2009Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing SpondylitisAn Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing SpondylitisSpondylitisDrug: infliximabGu JieruoNULLCompleted16 Years65 YearsBoth70Phase 4China
436EUCTR2006-001579-40-HU
(EUCTR)
18/12/200719/10/2007Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpAStudy of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA Spondyloarthropathies
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Remicade
INN or Proposed INN: infliximab
Schering-Plough FranceNULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;Hungary;Spain;Denmark
437NCT00576706
(ClinicalTrials.gov)
December 200717/12/2007PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal ToxicityA Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal ComplicationsRheumatoid Arthritis;Osteoarthritis;Ankylosing SpondylitisDrug: Rebamipide;Drug: MisoprostolKorea Otsuka Pharmaceutical Co.,Ltd.NULLCompleted19 YearsN/ABoth396Phase 3Korea, Republic of
438EUCTR2007-000087-25-GB
(EUCTR)
22/10/200727/07/2007An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07 Ankylosing Spondylitis
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: AclastaCambridge University Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
439EUCTR2007-002967-28-DE
(EUCTR)
19/10/200724/08/2007Pilot open label clinical trial with Abatacept in Ankylosing Spondylitis - ABATACEPT-AS-01Pilot open label clinical trial with Abatacept in Ankylosing Spondylitis - ABATACEPT-AS-01 T cell responses have been demonstrated against proteoglycan (an important cartilage protein) in human arthritides including ankylosing spondylitis. We suggest that a chronic, probably T cell mediated, immune response against cartilage is relevant in the pathogenesis of AS.Based on the above described findings about the role of T-cells in ankylosing spondylitis we assume that Abatacept has the potential to be an effective drug for treating ankylosing spondylitis. Trade Name: not applicable
Product Name: Orencia
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Charité University MedicineNULLNot RecruitingFemale: yes
Male: yes
30Germany
440NCT00544557
(ClinicalTrials.gov)
October 200715/10/2007Study Evaluating The Use Of Etanercept In Patients With Ankylosing SpondylitisObservational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic EvaluationAnkylosing SpondylitisDrug: EtanerceptPfizerNULLCompleted18 YearsN/AAll1715Germany
441EUCTR2006-001579-40-ES
(EUCTR)
31/07/200704/05/2007Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximabESTUDIO DE LA ENTESITIS PERIFÉRICA CON ECOGRAFÍA DOPPLER EN LAS ESPONDILOARTROPATÍAS TRATADAS CON INFLIXIMAB - EUSpAStudy of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximabESTUDIO DE LA ENTESITIS PERIFÉRICA CON ECOGRAFÍA DOPPLER EN LAS ESPONDILOARTROPATÍAS TRATADAS CON INFLIXIMAB - EUSpA SpondyloarthropathiesEspondiloartropatias
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Remicade
INN or Proposed INN: infliximab
Schering-Plough FranceNULLNot RecruitingFemale: yes
Male: yes
100Hungary;Denmark;France;Spain
442ChiCTR-TRC-13004564
2007-07-012013-07-05A 48 Week Randomized Controlled Trial to Evaluate the Clinical Outcomes of Ankylosing Spondylitis Managed by Chinese Medicine Compared with Western Medicine, a pilot study.A 48 Week Randomized Controlled Trial to Evaluate the Clinical Outcomes of Ankylosing Spondylitis Managed by Chinese Medicine Compared with Western Medicine, a pilot study. Ankylosing SpondylitisCM:Decoction of Chinese herbs + Moxibustion on 'Governor Vessel (GV)' + standard AS exercise regimen;WM treatment group:Celecoxib 200mg twice daily + standard AS exercise regimen;Guangdong Provincial Hospital of Chinese MedicineNULLCompleted1860BothCM:15;WM treatment group:15;I (Phase 1 study)China
443NCT02915354
(ClinicalTrials.gov)
July 200723/9/2016Relapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Following-up StudyRelapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Three Years' Following-up StudySpondylitis, Ankylosing;RecurrenceDrug: EtanerceptSun Yat-sen UniversityNULLCompleted18 YearsN/ABoth35Phase 4China
444EUCTR2005-004826-21-BE
(EUCTR)
01/06/200720/01/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Spain;Belgium;Ireland;Austria;Denmark;Germany;Norway;Italy;Sweden;United Kingdom
445NCT00724529
(ClinicalTrials.gov)
June 200725/7/2008Post Marketing Surveillance of RemicadePost Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)Crohn's Disease;Ankylosing SpondylitisBiological: InfliximabJanssen Korea, Ltd., KoreaNULLCompletedN/AN/ABoth938Korea, Republic of
446NCT00760669
(ClinicalTrials.gov)
May 200724/9/2008An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis ParticipantsPost Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis PatientsSpondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, PsoriaticDrug: Infliximab; observational study;Drug: MethotrexateJanssen Korea, Ltd., KoreaNULLCompletedN/AN/AAll1061Korea, Republic of
447EUCTR2006-005157-29-FR
(EUCTR)
27/04/200713/04/2007EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIMEFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIM Les patients seront traités par infliximab, avec ou sans méthotrexate associé, selon la pratique habituelle en accord avec le libellé de l’A.M.M. Seuls le nombre de prélèvements sanguins et de visites diffèreront des modalités thérapeutiques habituelles.
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
MedDRA version: 9.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders
Trade Name: Méthotrexate Bellon Comprimé
INN or Proposed INN: METHOTREXATE
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
CHRU-TOURSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
448EUCTR2006-002748-27-NL
(EUCTR)
13/04/200720/11/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis Active, severe and advanced axial ankylosing spondylitis
MedDRA version: 8.1;Level: LLT;Classification code 10048811;Term: Bechterew's disease
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
449EUCTR2006-001579-40-FR
(EUCTR)
02/04/200726/03/2007Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpAStudy of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA Spondyloarthropathies
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Remicade
INN or Proposed INN: infliximab
Schering-Plough FranceNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Hungary;Spain;Denmark
450NCT00434044
(ClinicalTrials.gov)
February 20079/2/2007Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing SpondylitisMulticenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth150Phase 3NULL
451EUCTR2006-002748-27-DE
(EUCTR)
15/01/200715/12/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis Active, severe and advanced axial ankylosing spondylitisTrade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
452EUCTR2006-001061-42-FI
(EUCTR)
09/01/200710/07/2006An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS)An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS).Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Wyeth Pharmaceuticals France, Wyeth Research DivisionNULLNot RecruitingFemale: yes
Male: yes
108Finland;United Kingdom;Denmark;Sweden
453NCT00420238
(ClinicalTrials.gov)
January 20078/1/2007Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing SpondylitisAnkylosing SpondylitisDrug: Etanercept (Enbrel);Other: PlaceboWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsAll82Phase 4France;Germany;Hungary;Netherlands
454EUCTR2006-002306-64-DE
(EUCTR)
28/12/200604/10/2006Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01 Moderate to severe ankylosing spondylitis who have had an inadequate response to or do not tolerate conventional therapy including NSAIDs, DMARDs and TNF alpha inhibitorsTrade Name: Rituximab/ Mabthera
Product Name: MabThera
Product Code: Ro45-2294
INN or Proposed INN: rituximab
Charité UniversitaetsmedizinNULLNot RecruitingFemale: yes
Male: yes
Germany
455EUCTR2005-001549-41-GR
(EUCTR)
08/12/200610/08/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
540Phase 3;Phase 4Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
456EUCTR2006-002748-27-FR
(EUCTR)
01/12/200619/12/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis Active, severe and advanced axial ankylosing spondylitis.Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;Hungary;Germany;Netherlands
457NCT00410046
(ClinicalTrials.gov)
December 20068/12/2006Extension Study Evaluating Etanercept in Ankylosing SpondylitisAn Open-label, Multicentre, Supplementary Extension Study of Etanercept in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/AAll84Phase 4Denmark;Finland;Sweden;United Kingdom
458NCT00873730
(ClinicalTrials.gov)
December 20061/4/2009Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in SpainA 12-week Randomized, Double-blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept;Drug: etanercept/placeboWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsAll108Phase 4NULL
459EUCTR2005-001549-41-CZ
(EUCTR)
28/11/200617/10/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: ENBREL
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
525Portugal;Finland;Hungary;United Kingdom;Germany;Czech Republic;Denmark;Ireland;Spain;Italy;Greece;Sweden
460EUCTR2006-001061-42-DK
(EUCTR)
03/11/200615/09/2006An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS)An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS).Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Wyeth Pharmaceuticals France, Wyeth Research DivisionNULLNot RecruitingFemale: yes
Male: yes
108Finland;United Kingdom;Denmark;Sweden
461EUCTR2004-003299-12-GB
(EUCTR)
11/10/200624/01/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
345Phase 3Finland;Belgium;Germany;United Kingdom
462EUCTR2006-002349-35-ES
(EUCTR)
30/09/200602/08/2006Estudio piloto randomizado, doble ciego, multicéntrico a 12 semanas para evaluar el efecto de etanercept 100mg y 50mg semanales en sujetos con espondilitis anquilosante.A 12-week randomized, double-blind, multicenter pilot study to evaluate the effect of etanercept 100 mg and 50 mg weekly in subjects with ankylosing spondylitis. - LOADETEstudio piloto randomizado, doble ciego, multicéntrico a 12 semanas para evaluar el efecto de etanercept 100mg y 50mg semanales en sujetos con espondilitis anquilosante.A 12-week randomized, double-blind, multicenter pilot study to evaluate the effect of etanercept 100 mg and 50 mg weekly in subjects with ankylosing spondylitis. - LOADET Espondilitis anquilosanteAnkylosing spondylitisTrade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: etanercept
Other descriptive name: TNR-001, TNFR:FC
Wyeth Farma S.A.NULLNot RecruitingFemale: yes
Male: yes
108Phase 4Spain
463NCT00367211
(ClinicalTrials.gov)
September 200618/8/2006Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.Osteoarthritis;Rheumatoid Arthritis;Ankylosing SpondylitisDrug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)POZENNULLCompleted18 YearsN/ABoth400Phase 3United States
464EUCTR2006-001061-42-SE
(EUCTR)
23/08/200613/06/2006An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS)An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS).Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Wyeth Pharmaceuticals France, Wyeth Research DivisionNULLNot RecruitingFemale: yes
Male: yes
108Finland;United Kingdom;Denmark;Sweden
465NCT00458185
(ClinicalTrials.gov)
August 20065/4/2007Study Evaluating Etanercept in Patients With Ankylosing SpondylitisMulticentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsBoth40Phase 4NULL
466EUCTR2006-001061-42-GB
(EUCTR)
31/07/200611/06/2006An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS)An open-label, multicentre, supplementary and extension study of Etanercept in subjects with Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS).Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Wyeth Pharmaceuticals France, Wyeth Research DivisionNULLNot Recruiting Female: yes
Male: yes
108 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFinland;Denmark;United Kingdom;Sweden
467EUCTR2005-005358-27-GB
(EUCTR)
12/07/200610/04/2006Efficacy of Rituximab (Mabthera) in active ankylosing spondylitis: a clinical and magnetic resonance imaging study - Rituximab in ASEfficacy of Rituximab (Mabthera) in active ankylosing spondylitis: a clinical and magnetic resonance imaging study - Rituximab in AS Ankylosing spondylitis (AS) is an inflammatory condition primarily affecting the spine. The disease may remain symptomatic and progressive life-long. It is part of the family of spondyloarthropathies which also comprises psoriatic arthritis, reactive arthritis and enteropathic arthritis.Trade Name: MabThera 500University Hospital of North StaffordshireNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
468NCT01685424
(ClinicalTrials.gov)
June 30, 200623/8/2012Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated AnalysisOsteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;ArthritisDrug: EtoricoxibOrganon and CoNULLCompletedN/AN/AAll79189United States
469EUCTR2005-001549-41-PT
(EUCTR)
29/06/200616/03/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel (etanercept)
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
525Finland;Hungary;Portugal;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
470EUCTR2005-004826-21-GR
(EUCTR)
28/06/200613/07/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
471EUCTR2004-003299-12-FI
(EUCTR)
26/04/200628/12/2005A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
345Finland;United Kingdom;Germany;Belgium
472EUCTR2004-003299-12-DE
(EUCTR)
04/04/200602/01/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
345Finland;United Kingdom;Germany;Belgium
473EUCTR2005-004826-21-AT
(EUCTR)
28/03/200603/03/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
474EUCTR2005-001549-41-DK
(EUCTR)
24/03/200621/12/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
540Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
475EUCTR2004-003299-12-BE
(EUCTR)
20/03/200601/02/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
345Phase 3Finland;Belgium;Germany;United Kingdom
476EUCTR2005-001549-41-SE
(EUCTR)
15/03/200616/02/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
540Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
477EUCTR2005-001549-41-FI
(EUCTR)
08/03/200614/11/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
540Portugal;Hungary;Finland;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
478EUCTR2005-004826-21-GB
(EUCTR)
06/03/200612/12/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
479EUCTR2005-004826-21-IE
(EUCTR)
03/03/200611/01/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
480EUCTR2005-004826-21-IT
(EUCTR)
28/02/200623/06/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors RHAPSODY - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors RHAPSODY - RHAPSODY Active Ankylosing Spondylitis
MedDRA version: 6.1;Level: PT;Classification code 10002556
INN or Proposed INN: AdalimumabABBOTTNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
481EUCTR2005-004826-21-DK
(EUCTR)
20/02/200605/01/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Greece;Finland;Belgium;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
482EUCTR2005-004826-21-ES
(EUCTR)
17/02/200619/01/2006Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. Revisión de la seguridad y eficacia con adalimumab en pacientes con espondilitis anquilosante activa. Estudio abierto para evaluar la respuesta a adalimumab en pacientes que no han respondido al tratamiento convencional o a los inhibidores del TNF alfa. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. Revisión de la seguridad y eficacia con adalimumab en pacientes con espondilitis anquilosante activa. Estudio abierto para evaluar la respuesta a adalimumab en pacientes que no han respondido al tratamiento convencional o a los inhibidores del TNF alfa. - RHAPSODY Active Ankylosing Spondylitis Espondilitis anquilosante activaTrade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
483EUCTR2005-002460-29-BE
(EUCTR)
17/02/200608/02/2006An Open Extension, Investigator Initiated Trial, to Examine Radiographic progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASICAn Open Extension, Investigator Initiated Trial, to Examine Radiographic progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC Ankylosing spondylitis (AS)Product Name: Remicade
Product Code: cA2
INN or Proposed INN: Infliximab
Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain)
Rheumazentrum Ruhrgebiet.NULLNot RecruitingFemale: yes
Male: yes
130Phase 4Finland;Belgium;Germany;United Kingdom
484EUCTR2005-001549-41-DE
(EUCTR)
15/02/200628/11/2005A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
540Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
485EUCTR2005-001549-41-IT
(EUCTR)
14/02/200609/10/2008A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondilitis (AS)
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
Trade Name: Salazopyrin En-Tabs
INN or Proposed INN: Sulfasalazine
WYETH LEDERLENULLNot RecruitingFemale: yes
Male: yes
525Portugal;Finland;Hungary;Czech Republic;United Kingdom;Germany;Denmark;Ireland;Spain;Italy;Greece;Sweden
486EUCTR2005-001549-41-GB
(EUCTR)
02/02/200629/11/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel (etanercept)
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
540 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesPortugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
487EUCTR2005-004826-21-SE
(EUCTR)
01/02/200623/12/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
488NCT00478660
(ClinicalTrials.gov)
February 200623/5/2007An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)Ankylosing SpondylitisDrug: adalimumab (Humira)AbbottNULLCompleted18 YearsN/ABoth1250Phase 3Austria;Belgium;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
489EUCTR2005-004826-21-DE
(EUCTR)
30/01/200607/12/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
490EUCTR2005-004826-21-NO
(EUCTR)
26/01/200605/12/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott LaboratoriesNULLNot RecruitingFemale: yes
Male: yes
1200Finland;United Kingdom;Germany;Denmark;Norway;Spain;Ireland;Italy;Greece;Austria;Sweden
491EUCTR2005-002460-29-FI
(EUCTR)
20/01/200612/12/2005An Open Label Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASICAn Open Label Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC Ankylosing spondylitis (AS)Product Name: Remicade
Product Code: cA2
INN or Proposed INN: Infliximab
Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain)
Rheumazentrum Ruhrgebiet.NULLNot RecruitingFemale: yes
Male: yes
130Finland;United Kingdom;Germany;Belgium
492EUCTR2005-004826-21-FI
(EUCTR)
20/01/200628/11/2005Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYReview of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODY Active Ankylosing SpondylitisProduct Name: Humira
INN or Proposed INN: Adalimumab
Abbott GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
1200Greece;Finland;Belgium;Spain;Ireland;Austria;Denmark;Germany;Norway;Italy;United Kingdom;Sweden
493EUCTR2005-001549-41-IE
(EUCTR)
09/01/200631/03/2006A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel (etanercept)
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
540Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
494EUCTR2005-001549-41-AT
(EUCTR)
27/12/200522/11/2005A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel (etanercept)
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
525Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
495EUCTR2005-001549-41-ES
(EUCTR)
27/12/200527/10/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCENDA Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel (etanercept)
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
525Phase 3;Phase 4Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden
496EUCTR2005-002460-29-GB
(EUCTR)
22/12/200503/10/2005 An Open Label Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC An Open Label Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC: (European Ankylosing Spondylitis Infliximab Cohort) - EASIC Ankylosing spondylitis (AS)Product Name: Remicade
Product Code: cA2
INN or Proposed INN: Infliximab
Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain)
Rheumazentrum Ruhrgebiet.NULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFinland;Belgium;Germany;United Kingdom
497NCT00247962
(ClinicalTrials.gov)
December 200531/10/2005Study Evaluating Etanercept and Sulphasalazine in Ankylosing SpondylitisA Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: etanercept;Drug: sulphasalazine (SSZ)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/AAll566Phase 4Australia;Austria;China;Czech Republic;Denmark;Finland;France;Germany;Hungary;Ireland;Italy;Netherlands;Poland;Qatar;Saudi Arabia;Spain;Sweden;United Kingdom;Greece;Portugal;Switzerland
498EUCTR2005-001549-41-HU
(EUCTR)
25/11/200513/10/2005A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND A Randomised, Double-Blind Study Comparing the Safety and Efficacy of Etanercept with Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND Subjects with Ankylosing Spondylitis (AS)Trade Name: Enbrel (etanercept)
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Salazopyrin En-Tabs
Product Name: sulphasalazine 500 mg En-Tabs
Product Code: SSZ
INN or Proposed INN: sulphasalazine
Other descriptive name: sulfasalazine, SSZ
Wyeth Research Division of Wyeth Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
525Phase 3;Phase 4Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Denmark;Germany;Sweden;Portugal;Greece;Finland;Spain
499EUCTR2005-002460-29-DE
(EUCTR)
12/09/200505/07/2005An Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASICAn Open Extension, Investigator Initiated Trial, to Examine Radiographic Progression, Efficacy and Safety, of Long-Term Treatment with Infliximab in Patients with Ankylosing Spondylitis EASIC (European Ankylosing Spondylitis Infliximab Cohort) - EASIC Ankylosing spondylitis (AS)Product Name: Remicade
Product Code: cA2
INN or Proposed INN: Infliximab
Other descriptive name: Anti-(human tumor necrosis factor) immunoglobulin G (human-mouse monoclonal cA2 heavy chain)
Rheumazentrum Ruhrgebiet.NULLNot RecruitingFemale: yes
Male: yes
130Finland;United Kingdom;Germany;Belgium
500NCT00778869
(ClinicalTrials.gov)
August 200523/10/2008Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED)Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment Compared to Healthy ControlsSpondylitis, AnkylosingBiological: RemicadeMerck Sharp & Dohme Corp.NULLCompleted18 Years70 YearsAll10Phase 4NULL
501NCT00126724
(ClinicalTrials.gov)
August 20052/8/2005Study of Intra-articular Delivery of tgAAC94 in Inflammatory Arthritis SubjectsA Phase I/II Study of Repeat Intra-articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis Subjects With and Without Concurrent TNF-alpha AntagonistsArthritis, Rheumatoid;Arthritis, Psoriatic;Ankylosing SpondylitisGenetic: tgAAC94 gene therapy vector;Genetic: tgAAC94 placeboTargeted Genetics CorporationNULLCompleted18 Years75 YearsBoth120Phase 1/Phase 2United States
502NCT00195416
(ClinicalTrials.gov)
June 200512/9/2005Study Investigating Enbrel Treatment for Ankylosing SpondylitisA Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth526Korea, Republic of
503NCT00202865
(ClinicalTrials.gov)
May 1, 200516/9/2005Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)CANaDian Evaluation of Low DosE Infliximab in Ankylosing SpondylitisSpondylitis, AnkylosingBiological: infliximab;Biological: PlaceboMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll76Phase 3Canada
504NCT00432432
(ClinicalTrials.gov)
February 20056/2/2007Combination Methotrexate and InfliximabThe Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging CorrelationAnkylosing SpondylitisDrug: Infliximab and MTXChinese University of Hong KongNULLCompleted18 Years70 YearsBoth38Phase 4NULL
505NCT02840695
(ClinicalTrials.gov)
January 200518/7/2016Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)Ankylosing Spondylitis;Spinal FracturesDrug: bDMARD treatmentUppsala UniversityNULLCompleted30 Years60 YearsAll9858N/ANULL
506NCT00779012
(ClinicalTrials.gov)
October 1, 200423/10/2008A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)Post-Registration Open-Label, Non-Comparative, Multicenter Study of Rate of Efficacy and Tolerance of the Use of Anti-TNF Chimeric Monoclonal Antibodies (Remicade) in Treatment of Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: InfliximabMerck Sharp & Dohme Corp.NULLCompleted18 Years70 YearsAll42Phase 4NULL
507NCT00779935
(ClinicalTrials.gov)
October 1, 200423/10/2008Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)Baseline Serum Vascular Endothelial Growth Factor (VEGF) Concentration as Predictive Factor of Response to Infliximab (Remicade) Therapy in Patients With Active Ankylosing Spondylitis Despite Conventional Treatment: a Multicenter Pilot StudySpondylitis, AnkylosingBiological: RemicadeMerck Sharp & Dohme Corp.NULLCompleted18 Years70 YearsAll44Phase 4NULL
508NCT00133315
(ClinicalTrials.gov)
September 200422/8/2005TNFalfa Blocking Treatment of SpondylarthropathiesTNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With SpondylarthropathiesSpondylarthropathies;Ankylosing Spondylitis;Psoriatic ArthritisDrug: Infliximab;Drug: Etanercept;Drug: AdalimumabHvidovre University HospitalNULLCompleted18 YearsN/ABoth50Phase 4Denmark
509NCT00418548
(ClinicalTrials.gov)
June 20044/1/2007Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing SpondylitisA Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsBoth350Phase 3NULL
510NCT00725543
(ClinicalTrials.gov)
June 200425/7/2008Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive InfusionsSpondylitis, AnkylosingBiological: InfliximabMerck Sharp & Dohme Corp.Centocor, Inc.CompletedN/AN/AAll358N/ANULL
511NCT00444340
(ClinicalTrials.gov)
April 20045/3/2007An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing SpondylitisAn Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (Etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth70Phase 4NULL
512NCT00224562
(ClinicalTrials.gov)
February 200414/9/2005The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a AntagonistsThe RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a AntagonistsRheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;PsoriasisDrug: TNF-alpha antagonistsAssistance Publique - Hôpitaux de ParisNULLRecruitingN/AN/ABothN/AFrance
513NCT00085644
(ClinicalTrials.gov)
January 200410/6/2004Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisA Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab (D2E7);Biological: placeboAbbottNULLCompleted18 YearsN/AAll315Phase 3United States
514NCT00195819
(ClinicalTrials.gov)
December 200316/9/2005Safety and Efficacy of Adalimumab in Patients With Active Ankylosing SpondylitisA Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab (D2E7);Biological: placeboAbbottNULLCompleted18 YearsN/AAll82Phase 3Canada;United States
515NCT00243750
(ClinicalTrials.gov)
September 200324/10/2005Methotrexate in Ankylosing Spondylitis (MTX in AS)Open Study for the Evaluation of the Efficacy of Methotrexate 20mg Given Subcutaneously in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: MethotrexateCharite University, Berlin, GermanyNULLActive, not recruiting18 Years70 YearsBoth20Phase 2Germany
516NCT00439283
(ClinicalTrials.gov)
April 200322/2/2007Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing SpondylitisStudy of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on DemandAnkylosing SpondylitisDrug: infliximab;Drug: methotrexateAssociation de Recherche Clinique en RhumatologieNULLCompleted18 YearsN/ABoth240Phase 3France
517NCT00648141
(ClinicalTrials.gov)
January 200328/3/2008Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing SpondylitisA 12-Week Symptomatic Effect Evaluation to Compare Celecoxib 200 mg QD, Celecoxib 200 mg BID and Diclofenac 75 mg SR BID in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Celecoxib;Drug: DiclofenacPfizerNULLCompleted18 Years75 YearsBoth458Phase 3Germany
518NCT01850121
(ClinicalTrials.gov)
January 20036/5/2013Remicade in the Treatment of Patients With Active Ankylosing SpondylitisRemicade in the Treatment of Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: InfliximabGöteborg UniversityNULLCompleted18 Years60 YearsBoth19Sweden
519NCT02528201
(ClinicalTrials.gov)
September 200218/6/2015A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing SpondylitisA Twelve Week, Randomized, Double Blind Parallel Group Study Of Two Doses Of Celecoxib Compared To Diclofenac In Patients With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Celecoxib 200 milligrams;Drug: Celecoxib 400 milligrams;Drug: diclofenac 50 milligramsPfizerNULLCompleted18 Years75 YearsBoth330Phase 4Norway
520NCT00207701
(ClinicalTrials.gov)
September 200213/9/2005A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug TherapyAnkylosing SpondylitisDrug: infliximabCentocor, Inc.Centocor BV, NetherlandsCompleted18 YearsN/ABoth279Phase 3NULL
521NCT00421980
(ClinicalTrials.gov)
June 20028/1/2007An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAn Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years66 YearsBoth84Phase 3Belgium
522NCT00244166
(ClinicalTrials.gov)
May 200225/10/2005Prednisolone in Active Ankylosing Spondylitis (AS)Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With PrednisoloneAnkylosing SpondylitisDrug: prednisoloneCharite University, Berlin, GermanyNULLRecruiting18 Years70 YearsBoth75Phase 2/Phase 3Germany
523NCT00421915
(ClinicalTrials.gov)
March 20028/1/2007Study Evaluating Etanercept Treatment of Patients With Ankylosing SpondylitisMulticenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final DataAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsBoth84Phase 3NULL
524NCT02183168
(ClinicalTrials.gov)
July 20014/7/2014Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing SpondylitisA Randomized, Open Label, 3-arm Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Meloxicam suppository;Drug: Meloxicam tablet;Drug: IndomethacinBoehringer IngelheimNULLCompletedN/AN/ABoth192Phase 3NULL
525NCT00000433
(ClinicalTrials.gov)
October 199918/1/2000Blocking Tumor Necrosis Factor in Ankylosing SpondylitisAnti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Anti-Tumor Necrosis FactorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years80 YearsBoth42Phase 2United States
526NCT00004288
(ClinicalTrials.gov)
May 199618/10/1999Phase II Pilot Study of Olsalazine for Ankylosing SpondylitisAnkylosing SpondylitisDrug: olsalazineNational Center for Research Resources (NCRR)University of RochesterCompleted18 Years65 YearsMale4Phase 2NULL
527EUCTR2020-004284-98-PL
(EUCTR)
15/12/2020Secukinumab open label roll-over extension protocolAn open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNAFemale: yes
Male: yes
628Phase 4United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Belgium;Poland;Brazil;Malaysia;Bulgaria;South Africa;Germany;Sweden;Korea, Republic of
528EUCTR2014-004532-18-Outside-EU/EEA
(EUCTR)
12/11/2014A Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing SpondylitisA Multi-Center, Open-Label Efficacy, Safety, and Pharmacokinetic Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB
AbbottNULLNAFemale: yes
Male: yes
41Japan
529EUCTR2020-004284-98-CZ
(EUCTR)
05/11/2020Secukinumab open label roll-over extension protocolAn open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;Classification code 10050576;Term: Psoriasis vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: SECUKINUMAB
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLNAFemale: yes
Male: yes
628Phase 4United States;Czechia;Greece;Spain;Guatemala;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Mexico;Poland;Belgium;Brazil;Malaysia;South Africa;Bulgaria;Germany;Sweden;Korea, Republic of
530EUCTR2010-019872-65-DE
(EUCTR)
04/08/2010Etoricoxib with naproxen in ankylosing spondylitis A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients with Ankylosing Spondylitis Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: Naprosyn
Product Name: Naprosysn
INN or Proposed INN: NAPROXEN
Other descriptive name: (+)-(S)-2-(6-methoxynaphthalen-2-yl) propanoic acid
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Taiwan;Estonia;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany
531EUCTR2018-000681-10-FR
(EUCTR)
06/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
532JPRN-JapicCTI-070346
22/01/2007Clinical study of TA-650 in patients with ankylosing spondylitisClinical study of TA-650 in patients with ankylosing spondylitis Ankylosing spondylitisIntervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion
Mitsubishi Tanabe Pharma CorporationNULL16BOTHPhase 3NULL
533EUCTR2018-000681-10-NL
(EUCTR)
07/01/2021An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Italy
534EUCTR2018-000681-10-BE
(EUCTR)
22/10/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
INN or Proposed INN: IXEKIZUMAB
Other descriptive name: LY2439821
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy