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临床试验/NCT04909801
NCT04909801进行中（未招募）3 期

A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate

Bristol-Myers Squibb75 个研究点 分布在 8 个国家目标入组 338 人开始时间: 2021年9月15日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
进行中（未招募）
发起方
入组人数
338
试验地点
75
主要终点
Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period
  • •Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
  • •Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization
  • •Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening
  • •At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening
  • •At least 3 tender and at least 3 swollen joints at screening and at randomization

排除标准

  • •Women who are breastfeeding
  • •Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia
  • •History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)
  • •At risk for tuberculosis
  • •Recent acute infection
  • •History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
  • •History of infection of a joint prosthesis or artificial joint
  • •History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis)
  • •History of primary immunodeficiency
  • •Current clinical findings or a history of a demyelinating disorder
  • •5 or more joints cannot be assessed for tenderness or swelling
  • •Other protocol-defined inclusion/exclusion criteria apply

研究组 & 干预措施

Arm 1: Abatacept + Methotrexate

Experimental

干预措施: Abatacept (Drug)

Arm 1: Abatacept + Methotrexate

Experimental

干预措施: Methotrexate (Drug)

Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)

Experimental

干预措施: Abatacept (Drug)

Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)

Experimental

干预措施: Adalimumab (Drug)

Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)

Experimental

干预措施: Methotrexate (Drug)

结局指标

主要结局

Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24

时间窗: Baseline, week 24

The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication.

次要结局

  • Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time(Day 29, 57, 85, 113, 141, 169)
  • Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) at Week 24(Week 24)
  • Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24(Baseline, week 24)
  • Percentage of SE+ Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) at Week 24(Week 24)
  • Adjusted Mean Change From Baseline in SE+ Participant-Reported Pain Visual Analog Scale (VAS) at Week 24(Baseline, week 24)
  • Percentage of SE+ Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time(Baseline, day 29, 57, 85, 113, 141, 169)
  • Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time(Baseline, day 29, 57, 85, 113, 141, 169)
  • Percentage of SE+ Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time(Baseline, day 29, 57, 85, 113, 141, 169)
  • Percentage of SE+ Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time(Day 29, 57, 85, 113, 141, 169)
  • Percentage of SE+ Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time(Day 29, 57, 85, 113, 141, 169)
  • Percentage of Participants Meeting 20% Improvement in American College of Rheumatology Criteria (ACR20) Response Over Time(Baseline, day 29, 57, 85, 113, 141, 169)
  • Percentage of Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response Over Time(Baseline, day 29, 57, 85, 113, 141, 169)
  • Percentage of Participants Meeting 70% Improvement in American College of Rheumatology Criteria (ACR70) Response Over Time(Baseline, day 29, 57, 85, 113, 141, 169)
  • Percentage of Participants Achieving Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein Remission (DAS28-CRP < 2.6) Over Time(Day 29, 57, 85, 113, 141, 169)
  • Percentage of Participants Achieving Clinical Disease Activity Index Remission (CDAI <= 2.8) Over Time(Day 29, 57, 85, 113, 141, 169)
  • Percentage of Participants Achieving Simple Disease Activity Index Remission (SDAI <= 3.3) Over Time(Day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for SE+ Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for SE+ Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for SE+ Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for SE+ Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for SE+ Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for SE+ Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for SE+ Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in Disease Activity Score 28 Joint Count Calculated Using C Reactive Protein (DAS28-CRP) Over Time for All Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time for All Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in Simple Disease Activity Index (SDAI) Over Time for All Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 3-5 Over Time for All Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 1-2 Over Time for All Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 6 Over Time for All Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in American College of Rheumatology (ACR) Core Components 7 Over Time for All Participants(Baseline, day 29, 57, 85, 113, 141, 169)
  • Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants(Up to week 24)
  • Adjusted Mean Change From Baseline in SF-36 Over Time for All Participants(Up to week 24)
  • Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants(Up to week 24)
  • Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants(Up to week 24)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (75)

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