Corticosteroids ( DrugBank: - )


12 diseases
告示番号疾患名(ページ内リンク)臨床試験数
41巨細胞性動脈炎2
46悪性関節リウマチ12
49全身性エリテマトーデス5
63特発性血小板減少性紫斑病5
64血栓性血小板減少性紫斑病3
97潰瘍性大腸炎29
107若年性特発性関節炎1
113筋ジストロフィー15
164眼皮膚白皮症1
220急速進行性糸球体腎炎1
296胆道閉鎖症2
300IgG4関連疾患1

41. 巨細胞性動脈炎


臨床試験数 : 131 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04012905
(ClinicalTrials.gov)
November 5, 20205/7/2019Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids TaperingA Randomized, Controled, Open Label Trial: Comparison Between Two Standardized Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell ArteritisGiant Cell ArteritisDrug: Corticosteroids for Systemic UseUniversity Hospital, CaenUniversity Hospital, Lille;Amiens University Hospital;University Hospital, Rouen;University Hospital, Limoges;Central Hospital Saint Quentin;Central Hospital, Valenciennes;Central Hospital, LisieuxNot yet recruiting50 YearsN/AAll150Phase 3NULL
2NCT01791153
(ClinicalTrials.gov)
July 22, 201312/2/2013An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell ArteritisGiant Cell ArteritisDrug: Tocilizumab;Drug: Prednisone;Drug: Tocilizumab Placebo;Drug: Prednisone Placebo;Drug: Corticosteroids;Drug: MethotrexateHoffmann-La RocheNULLCompleted50 YearsN/AAll251Phase 3United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom;Austria

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04755127
(ClinicalTrials.gov)
January 1, 202127/1/2021Arthroscopic Synovectomy of the Wrist in Inflammatory ArthritisARthroscopiC SynovecTomy Versus Intra-Articular Injection of Corticosteroids for the Management of Therapy Refractory Psoriatic or Rheumatoid Arthritis of the Wrist: a Randomized Controlled TrialWrist Arthritis;Psoriatic Arthritis;Rheumatoid Arthritis;SurgeryProcedure: Arthroscopic synovectomy of the wrist;Drug: Intra-articular corticosteroid injectionMaasstad HospitalNULLRecruiting18 YearsN/AAll80N/ANetherlands
2JPRN-jRCTs041200048
02/10/202002/10/2020Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-stateCertolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study Rheumatoid arthritis1) MTX*
- Continued group:
Continued at a stable dose and interval throughout the cours of the study.
Folic acid is continued if concomitantly used.
- Withdrawn group:
Week 0 to 12
Reduced after registration.
The dose of MTX is reduced to half, regardless of the initial dose.
Folic acid is continued if concomitantly used.
Week 12 to 52
Discontinued if low disease activity was maintained.
Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) CZP and csDMARDs other than MTX
Continued at a stable dose and interval throughout the course of the study in both groups.

3) Glucocorticoids
Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group.

4) Rescue treatment
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request.
- Restoring, restarting, or increasing doses of MTX
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Asai ShujiKojima ToshihisaRecruiting>= 20age oldNot applicableBoth114N/AJapan
3JPRN-jRCT1041190125
09/03/202009/03/2020PRECIOUS-B studyPatient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study Rheumatoid arthritis1) MTX*
Week 0 to 12
- Reduced after registration.
- The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose.
- The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used.
Week 12 to 52
- Discontinued if low disease activity was maintained.
- Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) BAR
- Continued at a stable dose and interval throughout the course of the study.

3) csDMARDs other than MTX
- Continued at a stable dose and interval throughout the course of the study.

4) Glucocorticoids
- Continued at a stable dose up to week 36, and allowed to taper after week 36.

5) Rescue treatments
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request
- Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX.
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids.
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Asai ShujiNULLRecruiting>= 20age oldNot applicableBoth51N/AJapan
4NCT04485325
(ClinicalTrials.gov)
November 4, 201930/4/2020Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA PatientsCapability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte)Rheumatic ArthritisDrug: Tofacitinib;Biological: EtanerceptDr. Frank BehrensPfizerRecruiting18 Years65 YearsAll192Phase 4Germany
5EUCTR2018-004539-54-DE
(EUCTR)
03/06/201910/04/2019Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapyCapability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Xeljanz
Trade Name: Enbrel
Trade Name: Celebrex
Fraunhofer-Institute for Translational Medicine and Pharmacology ITMPNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 4Germany
6JPRN-jRCTs041180071
13/10/201607/03/2019T-ReX studyTocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study Rheumatoid arthritisAt week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.Kojima ToshihisaNULLComplete>= 20age oldNot applicableBoth51N/AJapan
7NCT02264301
(ClinicalTrials.gov)
August 20143/10/2014Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid ArthritisThe Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Puerarin injection 400 mg;Drug: Qingkailing injection 40 mlChengdu PLA General HospitalNULLEnrolling by invitation18 Years75 YearsAll150N/AChina
8NCT02046603
(ClinicalTrials.gov)
March 4, 201424/1/2014A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic AgentOpen-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic AgentRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll162Phase 3United Kingdom
9NCT01724268
(ClinicalTrials.gov)
May 20127/11/2012Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis PatientRandomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot StudyRHEUMATOID ARTHRITISDrug: Pred + Meth;Drug: Anti TNF + MethHamad Medical CorporationNULLRecruiting18 YearsN/ABoth80Phase 3Qatar
10EUCTR2008-006064-11-LT
(EUCTR)
30/12/200919/10/2009An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroidsA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Rheumatoid arthritis (RA)
MedDRA version: 14.1;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: Golimumab Final Vialed Product (FVP)
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
564United States;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;Australia;New Zealand;Korea, Republic of
11NCT00720798
(ClinicalTrials.gov)
September 200522/7/2008An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core StudiesLong-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core StudiesRheumatoid ArthritisDrug: Tocilizumab;Drug: Disease-modifying anti-rheumatic drugs;Drug: Non-steroidal anti-inflammatory drugs;Drug: Oral corticosteroidsHoffmann-La RocheNULLCompleted18 YearsN/AAll2067Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Czech Republic;Denmark;Finland;France;Germany;Hong Kong;Iceland;Israel;Italy;Lithuania;Mexico;Netherlands;Norway;Panama;Peru;Portugal;Puerto Rico;Russian Federation;Serbia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;United Kingdom
12NCT00074438
(ClinicalTrials.gov)
June 200312/12/2003Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid ArthritisRandomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placeboGenentech, Inc.Roche Pharma AGCompleted18 Years80 YearsBoth465Phase 2United States

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04702256
(ClinicalTrials.gov)
December 9, 202130/11/2020Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMFInduction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMFLupus Nephritis;Systemic Lupus Erythematosus (SLE)Drug: Obinutuzumab administration;Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil;Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramineAssistance Publique - Hôpitaux de ParisRoche Pharma AGRecruiting14 YearsN/AAll196Phase 3France
2NCT02953821
(ClinicalTrials.gov)
December 16, 20161/11/2016Acthar Gel for Active Systemic Lupus Erythematosus (SLE)A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose CorticosteroidsLupus Erythematosus, SystemicDrug: Acthar Gel;Drug: Placebo GelMallinckrodtNULLCompleted18 YearsN/AAll172Phase 4United States;Argentina;Chile;Mexico;Peru;Colombia
3JPRN-UMIN000025328
2015/12/0525/12/2016A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus NephritisA Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis systemic lupus erythematosusTacrolimus
Mycophenolate Mofetil
The University of Hong KongNULLRecruiting18years-old75years-oldMale and Female200Not selectedJapan,Asia(except Japan)
4NCT00626197
(ClinicalTrials.gov)
February 200820/2/2008A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus ErythematosusLupus Nephritis;Systemic Lupus ErythematosusDrug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placeboGenentech, Inc.Roche Pharma AGCompleted16 YearsN/AAll381Phase 3United States
5NCT00430677
(ClinicalTrials.gov)
June 20071/2/2007Efficacy and Safety Study of Abatacept to Treat Lupus NephritisA Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF)Bristol-Myers SquibbNULLTerminated18 YearsN/AAll423Phase 2/Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;Puerto Rico

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05653349
(ClinicalTrials.gov)
March 31, 202323/11/2022Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)Primary Immune Thrombocytopenia (ITP)Biological: Ianalumab;Drug: Placebo;Drug: CorticosteroidsNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll225Phase 3Belgium;Hungary;Romania;Singapore;Spain;United Kingdom
2EUCTR2022-001672-34-ES
(EUCTR)
23/12/202211/10/2022A study of ianalumab (VAY736) in addition to first-line corticosteroids in patients with primary immune thrombocytopeniaA phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (VAYHIT1) Primary Immune thrombocytopenia (ITP);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: Ianalumab
Product Code: VAY736
INN or Proposed INN: Ianalumab
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3United States;Czechia;Hong Kong;Spain;Thailand;Turkey;Austria;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Malaysia;Singapore;Romania;Viet Nam;Australia;Germany;China;Japan
3ChiCTR2100045747
2020-12-012021-04-23Efficacy and safety study of corticosteroids plus hydroxychloroquine in first-line treatment of patients with primary immune thrombocytopenia with positive antinuclear antibodyEfficacy and safety study of corticosteroids plus hydroxychloroquine in first-line treatment of patients with primary immune thrombocytopenia with positive antinuclear antibody primary immune thrombocytopeniaExperimental group:hydroxychloroquine + Dexamethasone;Control group:Dexamethasone;Jinshan Hospital, Fudan UniversityNULLRecruiting18BothExperimental group:51;Control group:51;Phase 4China
4ChiCTR-OON-17014165
2018-01-012017-12-27A clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopeniaA clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopenia Immune Thrombocytopeniaone:Corticosteroids;two:Corticosteroids combined with Cyclosporin A ;Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyNULLRecruiting1865Bothone:100;two:100;China
5NCT00888901
(ClinicalTrials.gov)
May 200927/4/2009Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With EltrombopagAssessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.Idiopathic Thrombocytopenic PurpuraDrug: eltrombopag;Drug: corticosteroids (Aprednislon)Ingrid Pabinger, MDGlaxoSmithKlineCompleted18 Years90 YearsBoth30Phase 4Austria

64. 血栓性血小板減少性紫斑病


臨床試験数 : 92 薬物数 : 85 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 76
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05468320
(ClinicalTrials.gov)
November 21, 202218/7/2022Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic PurpuraAn Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic PurpuraDrug: Caplacizumab;Drug: Corticosteroids;Biological: anti-CD20 antibodySanofiNULLRecruiting18 Years80 YearsAll61Phase 3United States;Belgium;Czechia;France;Germany;Netherlands;Spain;United Kingdom
2NCT00799773
(ClinicalTrials.gov)
April 200926/11/2008Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)STAR - Study of TTP and Rituximab, A Randomized Clinical TrialThrombotic Thrombocytopenic PurpuraDrug: Rituximab;Procedure: Plasma exchange;Drug: CorticosteroidsNew England Research InstitutesNational Heart, Lung, and Blood Institute (NHLBI);Genentech, Inc.Terminated12 YearsN/AAll3Phase 3United States
3NCT00713193
(ClinicalTrials.gov)
November 20079/7/2008Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP)Thrombotic Thrombocytopenic PurpuraDrug: Cyclosporine;Drug: PrednisoneOhio State UniversityFood and Drug Administration (FDA)Completed18 YearsN/AAll16Phase 3United States

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05684484
(ClinicalTrials.gov)
February 1, 202326/12/2022Role of Roflumilast in Ulcerative ColitisClinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.Ulcerative ColitisDrug: Roflumilast 500 Ug ORAL TABLET [Daliresp];Drug: corticosteroids +immune suppressive +amino salicylic acidTanta UniversityNULLNot yet recruiting15 Years80 YearsAll52Phase 4NULL
2NCT04999228
(ClinicalTrials.gov)
November 1, 20215/8/2021Top Down Versus Step up in Pediatric Ulcerative ColitisFirst-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative ColitisUlcerative Colitis;Infliximab;ChildrenDrug: Infliximab;Drug: CorticosteroidsChildren's Hospital of Fudan UniversityNULLRecruiting6 Years18 YearsAll40Phase 4China
3NCT04879966
(ClinicalTrials.gov)
May 17, 20216/5/2021A Cohort Study Comparing IFX to CS for Moderate to Severe UCA Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative ColitisModerate to Severe Ulcerative ColitisDrug: Infliximab;Drug: CorticosteroidSixth Affiliated Hospital, Sun Yat-sen UniversityNULLRecruiting18 Years70 YearsAll342China
4NCT03942861
(ClinicalTrials.gov)
February 21, 201925/4/2019Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.Ulcerative Colitis;Ultrasound Therapy; ComplicationsDrug: Solu-MedrolCopenhagen University Hospital at HerlevNULLRecruiting18 Years70 YearsAll50Denmark
5EUCTR2017-000937-30-AT
(EUCTR)
22/02/201803/01/2018Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Spain;Poland;Belgium;Austria;Germany
6EUCTR2017-000937-30-PL
(EUCTR)
13/12/201725/09/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Spain;Belgium;Poland;Austria;Germany
7EUCTR2017-000937-30-ES
(EUCTR)
27/11/201710/10/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Poland;Belgium;Spain;Austria;Germany
8EUCTR2017-000937-30-FR
(EUCTR)
07/11/201719/09/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Spain;Poland;Belgium;Austria;Germany
9EUCTR2016-001170-15-ES
(EUCTR)
19/10/201702/08/2017Intravenous corticosteroids in moderate ulcerative colitisEfficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM Moderate flares of Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Urbason
INN or Proposed INN: methylprednisolone
Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE
GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 4Spain
10EUCTR2017-000937-30-DE
(EUCTR)
10/10/201725/09/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Spain;Poland;Belgium;Austria;Germany
11NCT03093259
(ClinicalTrials.gov)
October 1, 201717/3/2017ABX464 in Subjects With Moderate to Severe Active Ulcerative ColitisPhase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or CorticosteroidsUlcerative ColitisDrug: ABX464;Drug: Placebo oral capsuleAbivax S.A.NULLCompleted18 Years70 YearsAll32Phase 2Belgium
12EUCTR2017-000937-30-BE
(EUCTR)
29/09/201703/08/2017Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
ABIVAXNULLNot RecruitingFemale: yes
Male: yes
30Phase 2France;Hungary;Spain;Poland;Belgium;Austria;Germany
13NCT02425852
(ClinicalTrials.gov)
December 201621/4/2015A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe ColitisA Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe ColitisUlcerative ColitisDrug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: HydrocortisoneGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLRecruiting18 YearsN/AAll146Phase 4France
14NCT02665845
(ClinicalTrials.gov)
June 13, 201625/1/2016Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial.Ulcerative ColitisDrug: 5-ASA;Drug: CorticosteroidsCentre Hospitalier Universitaire de Saint EtienneNULLCompleted18 YearsN/AAll160Phase 3France;Greece;Israel;Italy;Korea, Republic of;Serbia
15NCT04564638
(ClinicalTrials.gov)
March 1, 201511/9/2020Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous CorticosteroidsLong-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous CorticosteroidsUlcerative ColitisDrug: CorticosteroidTampere University HospitalNULLCompletedN/AN/AAll217NULL
16NCT02033408
(ClinicalTrials.gov)
January 20143/12/2013Manipulating the Microbiome in IBD by Antibiotics and FMTManipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled TrialExacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's ColitisDrug: AB (antibiotics);Drug: CS (corticosteroids) OnlyShaare Zedek Medical CenterNULLCompleted2 Years75 YearsAll28N/ACanada;Finland;Israel;Italy;Poland;Spain
17NCT01941589
(ClinicalTrials.gov)
September 201330/8/2013Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative ColitisCombination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.Ulcerative ColitisDrug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids onlySheba Medical CenterNULLCompleted18 YearsN/AAll149Phase 4China;France;Greece;Israel;Italy;Korea, Republic of;Serbia
18NCT02922374
(ClinicalTrials.gov)
January 201328/9/2016Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative ColitisUlcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational StudyAcute Severe Colitis (ASC)Drug: corticosteroidsJinling Hospital, ChinaNULLActive, not recruiting18 YearsN/ABoth117Phase 1/Phase 2China
19NCT01536535
(ClinicalTrials.gov)
July 10, 201216/2/2012Predicting Response to Standardized Pediatric Colitis TherapyMulticenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.Ulcerative ColitisDrug: Mesalazine;Drug: IV Corticosteroid;Drug: Oral Corticosteroids;Other: Additional Therapies;Procedure: ColectomyConnecticut Children's Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed4 Years17 YearsAll431Phase 4United States;Canada
20EUCTR2009-015077-12-GB
(EUCTR)
23/11/200917/09/2009The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasiaThe use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia chronic ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Budenofalk 2mg rectal foam
Product Name: Budenofalk rectal foam
University Hospital Birmingham 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
21EUCTR2007-006692-37-GB
(EUCTR)
10/04/200825/01/2008 The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Vigantol Oel
Product Name: Vigantol Oel TM
Imperial College LondonNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
22EUCTR2006-004303-19-BE
(EUCTR)
08/06/200707/02/2007A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab
Cerimon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
135Czech Republic;United Kingdom;Belgium
23EUCTR2006-004303-19-CZ
(EUCTR)
09/05/200720/02/2007A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab
Cerimon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
181United Kingdom;Czech Republic;Belgium
24EUCTR2006-004303-19-SK
(EUCTR)
04/05/200708/03/2007A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab
Cerimon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
181Phase 2Czech Republic;Slovakia;Belgium;United Kingdom
25EUCTR2006-004303-19-GB
(EUCTR)
25/04/200706/12/2006A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab
Cerimon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
135Phase 2Czech Republic;Slovakia;Belgium;United Kingdom
26NCT00430898
(ClinicalTrials.gov)
January 200731/1/2007Basiliximab in Moderate to Severe Ulcerative ColitisA Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative ColitisUlcerative ColitisDrug: BasiliximabCerimon PharmaceuticalsNULLCompleted18 Years75 YearsBoth181Phase 2United States;Belgium;Czech Republic;India;Poland;Russian Federation;Slovakia;Ukraine;United Kingdom
27NCT00269438
(ClinicalTrials.gov)
December 200522/12/2005New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative ColitisPhase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of TherapyUlcerative ColitisDrug: 5 ASA, enemas, suppositories, corticosteroidsBausch Health Americas, Inc.NULLCompleted18 Years80 YearsAll225Phase 3United States
28NCT00267306
(ClinicalTrials.gov)
January 200416/12/2005Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative ColitisA Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous CorticosteroidsSevere Ulcerative ColitisDrug: VisilizumabFacet BiotechPDL BioPharma, Inc.Completed16 Years70 YearsBoth144Phase 1/Phase 2United States
29NCT00032305
(ClinicalTrials.gov)
March 200214/3/2002Research Study in Patients With Severe Ulcerative ColitisA Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to CorticosteroidsUlcerative ColitisDrug: VisilizumabFacet BiotechNULLCompleted18 Years70 YearsBoth20Phase 2/Phase 3United States

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00642460
(ClinicalTrials.gov)
May 200819/3/2008A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of TocilizumabJuvenile Idiopathic ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Non-steroidal anti-inflammatory drugs (NSAIDs);Drug: methotrexate;Drug: corticosteroidsHoffmann-La RocheNULLCompleted2 Years17 YearsAll112Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;Germany;Greece;Italy;Mexico;Netherlands;Norway;Poland;Slovakia;Spain;Sweden;United Kingdom;France

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000699-39-NL
(EUCTR)
28/06/202109/02/2021Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected by Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD) Ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
70Phase 3United States;France;Canada;Spain;Belgium;Austria;Australia;Netherlands;United Kingdom;Italy
2EUCTR2020-000699-39-AT
(EUCTR)
26/04/202129/01/2021Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD) Ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
70Phase 3United States;France;Canada;Spain;Belgium;Australia;Austria;Netherlands;United Kingdom;Italy
3EUCTR2020-000699-39-IT
(EUCTR)
19/04/202104/06/2021Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected by Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD) - na Ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: [FG-3019]
INN or Proposed INN: PAMREVLUMAB
FIBROGENNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
70Phase 3France;United States;Czechia;Canada;Spain;Belgium;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy
4EUCTR2020-000698-26-AT
(EUCTR)
02/02/202117/08/2020A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
96Phase 3United States;Czechia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands
5EUCTR2020-000698-26-NL
(EUCTR)
20/01/202108/09/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
90Phase 3United States;Czechia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands
6EUCTR2020-000698-26-IT
(EUCTR)
28/12/202006/11/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) - na Non-ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: [FG-3019]
INN or Proposed INN: PAMREVLUMAB
FIBROGENNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
90Phase 3United States;Czechia;Slovakia;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands
7EUCTR2020-000698-26-GB
(EUCTR)
16/12/202014/10/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
90Phase 3United States;Slovakia;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Belgium;Australia;Netherlands
8EUCTR2020-000698-26-CZ
(EUCTR)
15/12/202019/08/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
92Phase 3France;United States;Czechia;Czech Republic;Belgium;Spain;Austria;Netherlands;United Kingdom;Italy;Switzerland;China
9NCT04632940
(ClinicalTrials.gov)
December 11, 202012/11/2020Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMDA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyDrug: Pamrevlumab;Drug: Placebo;Drug: CorticosteroidsFibroGenNULLActive, not recruiting6 Years11 YearsMale70Phase 3United States;Australia;Austria;Belgium;Canada;China;France;Italy;Netherlands;Spain;United Kingdom;Switzerland
10NCT04371666
(ClinicalTrials.gov)
July 30, 202029/4/2020Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory DMDA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyDrug: Pamrevlumab;Drug: Placebo;Drug: CorticosteroidsFibroGenNULLActive, not recruiting12 YearsN/AMale92Phase 3United States;Australia;Austria;Belgium;Canada;China;Czechia;France;Israel;Italy;Netherlands;Spain;Switzerland;United Kingdom
11NCT02036463
(ClinicalTrials.gov)
November 20146/1/2014A Trial of Chronotherapy of Corticosteroids in Duchenne Muscular DystrophyCINRG0513: A Trial of Chronotherapy of Corticosteroids in Duchenne Muscular DystrophyDuchenne Muscular Dystrophy (DMD)Drug: Prednisone;Drug: PlaceboAnn & Robert H Lurie Children's Hospital of ChicagoChildren's Research InstituteWithdrawn3 Years6 YearsMale0Phase 2United States
12NCT02167217
(ClinicalTrials.gov)
April 17, 20143/2/2014Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular DystrophyPhase 2 Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: PrednisoloneWashington University School of MedicineNationwide Children's Hospital;Feinberg School of Medicine, Northwestern University;University of Texas Southwestern Medical Center;University of California, Davis;Nemours Hospital, Orlando, FLCompleted1 Month30 MonthsMale25Phase 2United States
13NCT01388764
(ClinicalTrials.gov)
January 20125/7/2011Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on CorticosteroidsPilot Study: To Assess the Safety, Tolerability and Effects of L-Arginine on Muscles in Boys With Dystrophinopathy on CorticosteroidsDystrophinopathy;Duchenne Muscular Dystrophy;Becker's Muscular DystrophyDrug: L-arginineMassachusetts General HospitalNULLCompleted7 Years11 YearsMale7Phase 1United States
14EUCTR2020-000699-39-BE
(EUCTR)
28/01/2021Evaluation of Pamrevlumab for the Treatment of Ambulatory Patients Affected by Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Ambulatory Subjects with Duchenne Muscular Dystrophy (DMD) Ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLNAFemale: no
Male: yes
70Phase 3France;United States;Canada;Spain;Belgium;Austria;Australia;Netherlands;United Kingdom;Italy
15EUCTR2020-000698-26-BE
(EUCTR)
21/09/2020Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with CorticosteroidsA Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) Non-ambulatory Duchenne Muscular Dystrophy
MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Pamrevlumab
Product Code: FG-3019
INN or Proposed INN: PAMREVLUMAB
FibroGen, Inc.NULLNAFemale: no
Male: yes
96Phase 3United States;Czechia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands

164. 眼皮膚白皮症


臨床試験数 : 15 薬物数 : 54 - (DrugBank : 34) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00514982
(ClinicalTrials.gov)
August 7, 20079/8/2007Medical Treatment of Colitis in Patients With Hermansky-Pudlak SyndromeAn Observational Study of the Immunopathogenesis of and Response to Step-Up Inflammatory Bowel Disease Therapy for Hermansky-Pudlak Syndrome-Associated ColitisHermanski-Pudlak Syndrome;Colitis;Cytokines;Lymphocytes;Drug EvaluationDrug: Mesalamine;Drug: Infliximab;Drug: Corticosteroids;Drug: 6-Mercaptopurine;Drug: Tacrolimus;Drug: AdalimumabNational Institute of Allergy and Infectious Diseases (NIAID)NULLWithdrawn18 YearsN/AAll0Phase 2United States

220. 急速進行性糸球体腎炎


臨床試験数 : 2 薬物数 : 4 - (DrugBank : 2) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 1
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00354198
(ClinicalTrials.gov)
August 200618/7/2006Efficacy of Pentoxifylline on Rapidly Progressive GlomerulonephritisClinical Efficacy of Combined Pentoxifylline and Conventional Immunosuppressive Regimens on Patients With Rapidly Progressive GlomerulonephritisGlomerulonephritisDrug: pentoxifylline;Drug: corticosteroidsNational Taiwan University HospitalNational Science Council, TaiwanTerminated20 Years80 YearsBoth7Phase 3Taiwan

296. 胆道閉鎖症


臨床試験数 : 71 薬物数 : 70 - (DrugBank : 39) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 60
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00294684
(ClinicalTrials.gov)
November 200521/2/2006A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following PortoenterostomyA Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants With Biliary AtresiaBiliary AtresiaDrug: Corticosteroids;Drug: PlaceboNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/A6 MonthsAll141N/AUnited States
2NCT00539565
(ClinicalTrials.gov)
January 20003/10/2007RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary AtresiaBiliary AtresiaDrug: prednisolone;Drug: placeboKing's College Hospital NHS TrustNULLEnrolling by invitationN/A100 DaysBoth100Phase 3United Kingdom

300. IgG4関連疾患


臨床試験数 : 40 薬物数 : 47 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02797665
(ClinicalTrials.gov)
May 20166/6/2016Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by CorticosteroidsAutoimmune Pancreatitis;IgG4-related Sclerosing Cholangitis;Obstructive JaundiceDrug: corticosteroids;Procedure: biliary stentPeking Union Medical College HospitalNULLRecruiting18 YearsN/AAll30N/AChina