NCT01689532已完成3 期
A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).
详细描述
This is a randomized (patients will be assigned to treatment by chance), double-blind (study personnel and patients will not know what treatments are being given), multicenter study. The expected duration of the study is 68 weeks. This will include 52 weeks of treatment with study agent with dosing every 2 weeks and 16 weeks of safety follow-up after the last dose. Disease-modifying antirheumatic drugs (DMARDs), including MTX and SSZ, are not permitted from 4 weeks before the first dosing with study agent until Week 24. The use of DMARDs is discouraged at or any time after Week 24; however, patients who have less than 20% improvement from baseline in both swollen and tender joint counts at Week 24 will be allowed to take DMARDs. At or any time after Week 16, the initiation and/or adjustment of oral corticosteroids will be allowed for patients who have less than 20% improvement from baseline in both swollen and tender joint counts at Week 16.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a Japanese man or woman with a diagnosis of rheumatoid arthritis (RA), according to the revised 1987 criteria of the American Rheumatism Association, for at least 3 months before screening
- •Has moderately to severely active RA with at least 6 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
- •Has been unresponsive to adequate treatment with methotrexate (MTX), sulfasalazine (SSZ), or combination of MTX or SSZ with other disease-modifying antirheumatic drugs (DMARDs) at screening due to lack of benefit after at least 12 weeks of marketed dose of MTX or SSZ, as assessed by the treating physician. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or overall disease activity
- •If using oral corticosteroids, must be on a stable dose equivalent to <=10 mg/day of prednisolone for at least 2 weeks prior to first dosing with study agent. If currently not using corticosteroids, the patient must not have received oral corticosteroids (by mouth) for at least 2 weeks prior to first dosing with study agent
- •If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain relievers) for RA, must be on a stable dose for at least 2 weeks prior to first dosing with study agent
排除标准
- •Has a history of intolerance to at least 2 or inadequate response to at least one anti-tumor necrosis factor-alpha (anti-TNF-alpha) agent after 3 months of therapy; has received anti-TNF-alpha (eg, infliximab, golimumab, adalimumab, or etanercept) within 3 months of first study agent dosing
- •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 B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent dosing or has evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy; has used any other biologic therapy for the treatment of RA within 3 months of first study agent dosing; has a history of sirukumab use
- •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 dosing
- •Has received leflunomide within 24 months before first study agent dosing and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable. Drug elimination procedure must be completed prior to obtaining informed consent
- •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 first study agent dosing; 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 first study agent dosing
研究组 & 干预措施
Sirukumab 100 mg
Experimental
干预措施: Sirukumab 100 mg (Drug)
Sirukumab 50 mg and Placebo
Experimental
干预措施: Sirukumab 50 mg (Drug)
Sirukumab 50 mg and Placebo
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAE)
时间窗: Baseline upto Week 68
A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is \[i.e.\] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.
次要结局
- Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response(At Weeks 16 and 24)
- Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response(At Weeks 16 and 24)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response(At Weeks 16 and 24)
- Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response(At Weeks 16 and 24)
- Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Percentage of Participants Who Achieved Major Clinical Response at Week 52(Week 52)
- Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24(At Weeks 16 and 24)
- Percentage of Participants Maintaining HAQ-DI Response(Baseline upto Week 52)
- Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52(At Weeks 16, 24 and 52)
- Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24(At Week 24)
- Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52(At Weeks 16, 24 and 52)
- Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52(Baseline, Weeks 24 and 52)
- Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24(At Weeks 16 and 24)
- Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24(Baseline, Weeks 16 and 24)
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24(Baseline, at Week 16 and 24)
- Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52(Baseline, Weeks 16, 24 and 52)
- Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52(Baseline, Weeks 16, 24 and 52)
- Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52(Baseline, Weeks 16, 24 and 52)
- Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52(Baseline, Weeks 16, 24 and 52)
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