2024-516704-41-00招募中4 期
RANDOMIZED CONTROLLED CLINICAL TRIAL EVALUATING METHOTREXATE OR LEFLUNOMIDE + TARGETED THERAPY VERSUS METHOTREXATE OR LEFLUNOMIDE + SULFASALAZINE + HYDROXYCHLOROQUINE IN PATIENTS WITH RHEUMATOID ARTHRITIS AND INSUFFICIENT RESPONSE TO METHOTREXATE OR LEFLUNOMIDE (The BIO-3 trial)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 18
- 主要终点
- Low disease activity (DAS28-CRP<3.2) and a daily dose ≤ 7.5 mg of equivalent prednisone under the randomized strategy after, at least, 11 months of follow up.
研究概览
简要总结
To demonstrate whether or not targeted therapies are more effective than triple therapies in methotrexate or leflunomide-IR patients with RA.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomised and controlled Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria
- •DAS28-CRP>3.2
- •Insufficient response to methotrexate at a weekly dose ≥ 15mg after at least 3 months or to leflunomide at a dose of 10 (in case 20 mg are not well tolerated) to 20 mg per day after 3 months of treatment
- •RA radiographic erosions and/or serum rheumatoid factor and/or anti-Cyclic Citrullinated Peptide (Anti-CCP)
- •Age greater or equal to 18 years
- •Written informed consent, dated and signed before initiating any trial-related procedure
- •Affiliation to a social insurance system
- •Women of child bearing potential, negative β-HCG assay (blood test)
- •Effective method of birth control during the study and continuing after the discontinuation of the investigational drug or study. The duration will depend on the drug used (referred to the summary product characteristic).
排除标准
- •Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor)*
- •Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
- •Women of child bearing potential, unless they are using an effective method of birth control
- •Patient under law protection
- •Previous treatment with or contraindication to triple therapy*
- •Other inflammatory arthritis except those associated to Sjögren’s syndrome
- •Contraindication to all biologics/ JAK/STAT inhibitors or to methotrexate, leflunomide, sulfasalazine and hydroxychloroquine
- •Corticosteroids at a dose >15 mg/d of equivalent prednisone for at least 4 weeks before the inclusion
- •Absence of tuberculosis screening for patients in the biologic arm
- •Patient who cannot be followed during 12 months
- •Pregnancy, breastfeeding, desire of pregnancy in the 12 months
- •Drug addiction, addiction to alcohol
结局指标
主要结局
Low disease activity (DAS28-CRP<3.2) and a daily dose ≤ 7.5 mg of equivalent prednisone under the randomized strategy after, at least, 11 months of follow up.
Low disease activity (DAS28-CRP<3.2) and a daily dose ≤ 7.5 mg of equivalent prednisone under the randomized strategy after, at least, 11 months of follow up.
次要结局
- Serious adverse events rate
- Blood concentrations of hydroxychloroquine, leflunomide, sulfasalazine and methotrexate in the triple therapy group and methotrexate, leflunomide, biologic / JAK/STAT inhibitor and anti-drug antibody in the other group at 6, and 12 months
- Clinical disease activity index (CDAI) at inclusion, 3, 6, 9 and 12 months
- DAS 28 CRP score at inclusion, 3, 6, 9 and12 months
- 52010 ACR/EULAR classification Criteria for RA, ACR 20, 50, 70 and Boolean remission at 3, 6, 9 and 12 months
- Modified Sharp Van der Hejde score at inclusion and at 12 month
- Change in comedications (corticosteroids, dose of methotrexate or leflunomide, subcutaneous use of methotrexate), treatment observance
- SF36 score, Rapid score, HAQ score, RAID score, FACIT score at inclusion, 3, 6, 9 and at 12 months
- QUALISEX score at inclusion, 6 months and at 12 months
- Medico-economic evaluation results at inclusion, 3, 6, 9 and at 12 months
研究者
Jacques-Eric GOTTENBERG
Scientific
Les Hopitaux Universitaires De Strasbourg
研究点 (18)
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