EUCTR2010-022243-38-PT进行中（未招募）不适用
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 840
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Have a diagnosis of rheumatoid arthritis (RA) for at least 3 months before screening
- •- Have moderately to severely active RA with at least 4 of 68 tender joints and 4 of 66 swollen joints, at screening and at baseline
- •- Have had anti-tumor necrosis factor (TNF)-alpha therapy and were unresponsive by 1 of the following 2 reasons: Lack of benefit to at least 1 anti-TNF-alpha biologic therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, yisaipu, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab; Intolerance to at least 2 anti-TNF-alpha biologic therapies, as assessed by the treating physician, to etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol, or infliximab or have documented intolerance to an anti-TNF-alpha agent as described above that precludes further administration of anti-TNF-alpha agents
- •- If using oral corticosteroids, must be on a stable dose equivalent to <=10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
- •- If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
- •- If using non-biologic DMARDs such as methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the DMARD
- •- C-reactive protein (CRP) >= 8.00 mg/L or erythrocyte sedimentation rate (ESR) >= 28 mm/hr at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 733
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
排除标准
- •- Has received infliximab, infliximab biosimilar, or golimumab IV within 8 weeks of the first study agent administration.
- •- Has received golimumab SC, adalimumab, or certolizumab pegol within 6 weeks of the first study agent administration.
- •- Has received etanercept or yisaipu within 4 weeks of the first study agent administration.
- •- Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy. Has used tocilizumab within 8 weeks of the first study agent administration.
- •- Has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy
- •- Has used anakinra within 1 week of first study agent administration
- •- Has used abatacept or any other biologic therapy for the treatment of RA within 8 weeks of the first study agent administration
- •- Has received intra-articular (IA), intramuscular (IM), or intravenous (IV) corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration
- •- Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable. If a drug elimination procedure is performed during screening, the M1 metabolite should be measured and found to be undetectable.
- •- Has a history of cyclophosphamide or cytotoxic agent use
- •- Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent administration
- •- Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half lives, whichever is longer, before the first study agent administration
研究者
相似试验
进行中（未招募）
不适用
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - NAActive rheumatoid arthritis (RA)EUCTR2005-001742-16-NLCentocor B.V.420
招募中
不适用
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to evaluate the efficacy and safety of ginkgo biloba leaf ex. inj. in Salvage treatment for Sudden Deafness PatientsDiseases of the ear and mastoid processKCT0003292Asan Medical Center68
进行中（未招募）
不适用
A clinical trial to test the safety and effectiveness of aripiprazole against placebo in children and adolescents with Tourette’s DisorderEUCTR2012-003488-23-HUOtsuka Pharmaceutical Development & Commercialization, Inc.67
进行中（未招募）
1 期
A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapylcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2018-000930-37-ESAbbVie Deutschland GmbH & Co. KG60
进行中（未招募）
不适用
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Children And Adolescent Outpatients With Major Depressive DisorderEUCTR2008-001875-32-Outside-EU/EEAPfizer Inc.363