jRCT2011220026进行中（未招募）不适用
A phase III clinical study to evaluate the efficacy and safety of IDEC-C2B8 in patients with active rheumatoid arthritis who show an inadequate response or intolerance to previous or current treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 113
- 主要终点
- ACR20 response
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Japanese patients with rheumatoid arthritis diagnosed according to the 2010 ACR/EULAR Classification Criteria for Rheumatoid Arthritis.
- •Patients to whom either (1) or (2) below applies:
- •(1) Have active disease and history of treatment with at least one approved bDMARD or JAK inhibitor but who have had difficulty continuing treatment due to lack of response or to drug intolerance.
- •(2) Have history or comorbidity (including suspected) of malignant lymphoma, lymphoproliferative disease, malignancy, or demyelinating diseases.
- •Patients who have been diagnosed with rheumatoid arthritis for six months or longer.
- •Patients who are at 18 years of age or older at the time of consent to participate in this study.
- •Patients who have sufficiently understood the objectives, details, and risks of the study and have themselves provided written consent to participate in the study of their own free will.
排除标准
- •Patients who received or are scheduled to receive disease-modifying antirheumatic drugs within 4 weeks or infliximab within 6 weeks prior to the first administration of IDEC-C2B8 or placebo in the blinded period.
- •Patients who have newly started treatment with methotrexate, changed the dosage form of methotrexate, or changed or discontinued their weekly methotrexate dose within 4 weeks before enrollment.
- •Patients who have newly started treatment with csDMARDs (excluding csDMARDs continued from 4 weeks or more before enrollment), changed the type and the dosage form of csDMARDs, or changed or discontinued the dose (csDMARDs consist of sodium aurothiomalate, bucillamine, salazosulfapyridine, leflunomide, tacrolimus hydrate, and iguratimod) within four weeks before enrollment.
- •Patients who have newly started treatment with glucocorticosteroids, changed the type of glucocorticosteroids, or changed glucocorticosteroid dose (including discontinuation of treatment with glucocorticosteroids), within 4 weeks before enrollment.
- •Patients with a history of treatment with anti-CD20 monoclonal antibody including rituximab (genetic recombination), within 1 year before enrollment.
- •Pregnant women, women testing positive on pregnancy test, women giving birth, or breastfeeding women.
- •Patients who have previously undergone surgical treatment on more than three joints for rheumatoid arthritis, including synovectomy, arthroplasty, joint replacement surgery, and joint fusion surgery.
- •Patients who have tuberculosis or a history of active tuberculosis within 3 years before enrollment.
- •Patients to whom either of (1) or (2) below applies:
- •(1) Confirmed positive test for HIV antibody
- •(2) Positive test for at least one of the following: HBs antigen, HBs antibody, HBc antibody, or HCV antibody
- •Patients with severe psychiatric disorders.
结局指标
主要结局
ACR20 response
时间窗: Week 24 after the day of administration of the first dose of IDEC-C2B8 or placebo in the blinded period
The proportion of patients with ACR20 response
次要结局
- ACR20, ACR50 and ACR70 responses
- Low disease activity and remission
- EULAR improvement criteria
- ACR core set
- SF-36 (PCS, MCS) and FACIT-F
- Total Sharp/van der Heijde score, Joint Space Narrowing score, and Erosion Score
研究者
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