271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 563 / 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05164198 (ClinicalTrials.gov) | January 15, 2022 | 8/11/2021 | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity | Multicenter, Prospective Clinical Trial for Optimizing TNF Inhibitor Dose Adjustment in Ankylosing Spondylitis Patients With Stable Disease Activity | Ankylosing Spondylitis;Axial Spondyloarthritis | Biological: Adalimumab and its biosimilars;Biological: Biological: Etanercept and its biosimilars;Biological: Golimumab;Biological: Infliximab biosimilar | Hanyang University Seoul Hospital | Linical Korea | Not yet recruiting | 18 Years | 65 Years | All | 448 | Phase 4 | NULL |
| 2 | EUCTR2016-002061-54-IT (EUCTR) | 13/10/2016 | 15/11/2018 | Switch 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. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | ||
| 3 | EUCTR2015-002284-42-FI (EUCTR) | 18/09/2015 | 28/08/2015 | The 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 activit | INTENT: 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 specify | Trade 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 | READE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1650 | Phase 1 | Finland | ||
| 4 | NCT02605642 (ClinicalTrials.gov) | September 10, 2015 | 2/9/2015 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade | PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB) | Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: CT-P13 | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Completed | 18 Years | N/A | All | 351 | Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy | |
| 5 | NCT02293681 (ClinicalTrials.gov) | April 10, 2015 | 14/11/2014 | An Observational Study of Infliximab in Participants Suffering From Ankylosing Spondylitis With Hip Involvement | A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement | Spondylitis, Ankylosing | Drug: Infliximab;Drug: NSAIDs;Drug: DMARDs | Janssen Research & Development, LLC | NULL | Terminated | 16 Years | 40 Years | All | 76 | N/A | China |
| 6 | NCT02359903 (ClinicalTrials.gov) | February 2015 | 30/1/2015 | Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis | International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Infliximab (BCD-055);Drug: Infliximab (Remicade) | Biocad | NULL | Completed | 18 Years | 65 Years | All | 90 | Phase 1 | Belarus;Russian Federation |
| 7 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A 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 psoriasis | A 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 AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Norway | ||||
| 8 | NCT02132234 (ClinicalTrials.gov) | June 2013 | 28/4/2014 | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis | Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Hypertension | Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab | Jagiellonian University | Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland | Recruiting | 18 Years | N/A | Both | 100 | Phase 4 | Poland |
| 9 | JPRN-UMIN000015297 | 2012/09/19 | 01/10/2014 | The feasibility study of accelated infliximab infusion from initial administration | The 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 Hospital | NULL | Recruiting | 20years-old | 70years-old | Male and Female | 54 | Phase 2 | Japan |
| 10 | JPRN-UMIN000007806 | 2012/06/01 | 01/05/2012 | 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 Hospital | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 54 | Phase 2 | Japan | |
| 11 | NCT01610947 (ClinicalTrials.gov) | May 14, 2012 | 24/5/2012 | Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity | Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial | Spondyloarthritis | Drug: Adalimumab, Etanercept, Golimumab or infliximab | University Hospital, Montpellier | NULL | Completed | 18 Years | N/A | All | 398 | N/A | France |
| 12 | NCT01571206 (ClinicalTrials.gov) | March 2012 | 23/3/2012 | An 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 1.1 | An 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 1.1 | Ankylosing Spondylitis | Biological: Infliximab | Celltrion | NULL | Completed | 18 Years | 75 Years | Both | 174 | Phase 1 | Korea, Republic of |
| 13 | NCT01220518 (ClinicalTrials.gov) | October 2010 | 4/10/2010 | Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS) | Randomized, Double-blind, Parallel-group, Phase 1 Study | Ankylosing Spondylitis | Drug: Infliximab | Celltrion | NULL | Completed | 18 Years | 75 Years | Both | 257 | Phase 1 | Korea, Republic of |
| 14 | NCT01148901 (ClinicalTrials.gov) | June 2010 | 21/6/2010 | Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451) | Hip Arthritis Associated With AS Efficacy and Safety of Early Treatment With Infliximab (Remicade®) | Ankylosing Spondylitis | Drug: Infliximab | Merck Sharp & Dohme Corp. | Hospital Universitario Reina Sofia;Dr. Jose María Martos Becerra (Central Radiological Assessment) – Hospital de Alta Resolución, Puente Genil (Spain) | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | Spain |
| 15 | EUCTR2009-016587-36-ES (EUCTR) | 15/03/2010 | 27/01/2010 | Artritis 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.A | NULL | Not Recruiting | Female: yes Male: yes | 70 | Spain | |||
| 16 | NCT00844805 (ClinicalTrials.gov) | September 2009 | 13/2/2009 | Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) | Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial | Ankylosing Spondylitis;Axial Spondyloarthritis | Drug: Infliximab;Drug: Placebo;Drug: Naproxen | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 48 Years | All | 158 | Phase 3 | Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;United States |
| 17 | EUCTR2006-001579-40-DK (EUCTR) | 16/04/2008 | 04/09/2007 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Study 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 France | NULL | Not Recruiting | Female: yes Male: yes | 120 | France;Hungary;Spain;Denmark | |||
| 18 | NCT01072058 (ClinicalTrials.gov) | February 2008 | 18/2/2010 | Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker | Prospective 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 Blocker | Arthritis, Rheumatoid;Spondylitis, Ankylosing | Drug: TNF blockers (infliximab, adalimumab, etanercept) | University of Sao Paulo | NULL | Active, not recruiting | 18 Years | 70 Years | Both | 100 | Phase 4 | Brazil |
| 19 | NCT00936143 (ClinicalTrials.gov) | January 2008 | 7/7/2009 | Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis | An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis | Spondylitis | Drug: infliximab | Gu Jieruo | NULL | Completed | 16 Years | 65 Years | Both | 70 | Phase 4 | China |
| 20 | EUCTR2006-001579-40-HU (EUCTR) | 18/12/2007 | 19/10/2007 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Study 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 France | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;Hungary;Spain;Denmark | ||
| 21 | NCT00507403 (ClinicalTrials.gov) | October 2007 | 24/7/2007 | Infliximab and Methotrexate in Ankylosing Spondylitis | Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: infliximab | University Hospital, Tours | Institut National de la Santé Et de la Recherche Médicale, France | Completed | 18 Years | 65 Years | All | 30 | Phase 4 | France |
| 22 | EUCTR2006-001579-40-ES (EUCTR) | 31/07/2007 | 04/05/2007 | Study 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 | Study 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 France | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Denmark;France;Spain | |||
| 23 | NCT00724529 (ClinicalTrials.gov) | June 2007 | 25/7/2008 | Post Marketing Surveillance of Remicade | Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ankylosing Spondylitis | Biological: Infliximab | Janssen Korea, Ltd., Korea | NULL | Completed | N/A | N/A | Both | 938 | Korea, Republic of | |
| 24 | NCT00760669 (ClinicalTrials.gov) | May 2007 | 24/9/2008 | An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants | Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients | Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, Psoriatic | Drug: Infliximab; observational study;Drug: Methotrexate | Janssen Korea, Ltd., Korea | NULL | Completed | N/A | N/A | All | 1061 | Korea, Republic of | |
| 25 | EUCTR2006-005157-29-FR (EUCTR) | 27/04/2007 | 13/04/2007 | EFFET DU METHOTREXATE SUR LA RELATION DOSE - EFFET DE L'INFLIXIMAB DANS LA SPONDYLARTHRITE ANKYLOSANTE - SPAXIM | EFFET 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-TOURS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 26 | EUCTR2006-001579-40-FR (EUCTR) | 02/04/2007 | 26/03/2007 | Study of peripheral enthesitis with ultrasonography doppler in spondyloarthropathies treated with infliximab - EUSpA | Study 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 France | NULL | Not 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): yes | France;Hungary;Spain;Denmark | ||
| 27 | EUCTR2005-002460-29-BE (EUCTR) | 17/02/2006 | 08/02/2006 | An 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 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 4 | Finland;Belgium;Germany;United Kingdom | ||
| 28 | EUCTR2005-002460-29-FI (EUCTR) | 20/01/2006 | 12/12/2005 | 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. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Finland;United Kingdom;Germany;Belgium | |||
| 29 | EUCTR2005-002460-29-GB (EUCTR) | 22/12/2005 | 03/10/2005 | 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. | NULL | Not 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): yes | Finland;Belgium;Germany;United Kingdom | ||
| 30 | NCT00237419 (ClinicalTrials.gov) | December 2005 | 10/10/2005 | Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis | 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) | Ankylosing Spondylitis | Drug: infliximab | Rheumazentrum Ruhrgebiet | Centocor BV;Trial Coordination Center, 9713 GZ Groningen;PPD | Recruiting | 18 Years | N/A | Both | 149 | N/A | Belgium;Finland;France;Germany;Netherlands;United Kingdom |
| 31 | EUCTR2005-002460-29-DE (EUCTR) | 12/09/2005 | 05/07/2005 | An 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 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Finland;United Kingdom;Germany;Belgium | |||
| 32 | NCT00778869 (ClinicalTrials.gov) | August 2005 | 23/10/2008 | Analysis 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 Controls | Spondylitis, Ankylosing | Biological: Remicade | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 4 | NULL |
| 33 | NCT00202865 (ClinicalTrials.gov) | May 1, 2005 | 16/9/2005 | Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352) | CANaDian Evaluation of Low DosE Infliximab in Ankylosing Spondylitis | Spondylitis, Ankylosing | Biological: infliximab;Biological: Placebo | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 76 | Phase 3 | Canada |
| 34 | NCT00432432 (ClinicalTrials.gov) | February 2005 | 6/2/2007 | Combination Methotrexate and Infliximab | The Efficacy of Combination Methotrexate and Infliximab in Patients With Ankylosing Spondylitis:A Clinical and Magnetic Resonance Imaging Correlation | Ankylosing Spondylitis | Drug: Infliximab and MTX | Chinese University of Hong Kong | NULL | Completed | 18 Years | 70 Years | Both | 38 | Phase 4 | NULL |
| 35 | NCT00779012 (ClinicalTrials.gov) | October 1, 2004 | 23/10/2008 | A 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 Spondylitis | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 42 | Phase 4 | NULL |
| 36 | NCT00779935 (ClinicalTrials.gov) | October 1, 2004 | 23/10/2008 | Growth 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 Study | Spondylitis, Ankylosing | Biological: Remicade | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 70 Years | All | 44 | Phase 4 | NULL |
| 37 | NCT00133315 (ClinicalTrials.gov) | September 2004 | 22/8/2005 | TNFalfa Blocking Treatment of Spondylarthropathies | TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies | Spondylarthropathies;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Infliximab;Drug: Etanercept;Drug: Adalimumab | Hvidovre University Hospital | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 4 | Denmark |
| 38 | NCT00725543 (ClinicalTrials.gov) | June 2004 | 25/7/2008 | Investigation 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 Infusions | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | N/A | N/A | All | 358 | N/A | NULL |
| 39 | NCT00818168 (ClinicalTrials.gov) | July 2003 | 6/1/2009 | Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED) | Remicade Safety Line (Ankylosing Spondylitis) | Spondylitis, Ankylosing | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | 18 Years | N/A | All | 320 | N/A | Germany |
| 40 | NCT00439283 (ClinicalTrials.gov) | April 2003 | 22/2/2007 | Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis | Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis: Comparison of Infusion Every 6 Weeks Versus Infusion on Demand | Ankylosing Spondylitis | Drug: infliximab;Drug: methotrexate | Association de Recherche Clinique en Rhumatologie | NULL | Completed | 18 Years | N/A | Both | 240 | Phase 3 | France |
| 41 | NCT01850121 (ClinicalTrials.gov) | January 2003 | 6/5/2013 | Remicade in the Treatment of Patients With Active Ankylosing Spondylitis | Remicade in the Treatment of Patients With Active Ankylosing Spondylitis | Ankylosing Spondylitis | Drug: Infliximab | Göteborg University | NULL | Completed | 18 Years | 60 Years | Both | 19 | Sweden | |
| 42 | NCT00207701 (ClinicalTrials.gov) | September 2002 | 13/9/2005 | A 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 Therapy | Ankylosing Spondylitis | Drug: infliximab | Centocor, Inc. | Centocor BV, Netherlands | Completed | 18 Years | N/A | Both | 279 | Phase 3 | NULL |
| 43 | JPRN-JapicCTI-070346 | 22/01/2007 | Clinical study of TA-650 in patients with ankylosing spondylitis | Clinical study of TA-650 in patients with ankylosing spondylitis | Ankylosing spondylitis | Intervention name : TA-650 (Infliximab) Dosage And administration of the intervention : Intravenous drip infusion | Mitsubishi Tanabe Pharma Corporation | NULL | 16 | BOTH | Phase 3 | NULL |