EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The main objective of this trial is to test abatacept efficacy
研究概览
简要总结
The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.
详细描述
The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.
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
- None
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
- •Patients with PR according to Guerne and Weissman modified criteria (18) and with:
- •Disease evolution > 3 months and < 24 months.
- •ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence).
- •Greater than 18 years of age.
排除标准
- •Persistent arthritis: (involvement in one or more joints > 1 week).
- •Criteria of other rheumatic diseases (RA, SLE, etc.).
- •Evidence of radiographic damage (join erosions).
- •Absence of ACPA or RF.
- •Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).
- •Steroid treatment one month before study entry.
- •Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide, sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs.
- •Pregnant women or who want to be pregnant during the study.
研究组 & 干预措施
abatacept
abatacept monotherapy (subcutaneous route).: 125 mg solution for injection in pre-filled syringe. In the first year (0-12 months) at a a dose of 125 mg per week (full dose) and in the second year (12-24 months) at a dose of 125 mg every other week (q2w) (optimized dose) injection) - 125 mg x week - subcutaneous use.
干预措施: Abatacept Injection (Drug)
hydroxycloroquina
Hydroxyclorquina (Coated tablet)- (5 mg/Kg/day) monotherapy for 2 years (0-48 months)
干预措施: hydroxycloroquina (Drug)
结局指标
主要结局
The main objective of this trial is to test abatacept efficacy
时间窗: At any time during the follow-up (up to 24 months)
number of participants developed persistent arthritis fulfilling criteria of Rheumatoid Arthritis according to EULAR/ACR 2010 classification criteria persistent arthritis (RA criteria)
次要结局
- number of participants with titles positives on serum ACPA.(anti-CarP antibodies)(At any time during the follow-up (up to 24 months))
- Number of participants with treatment-related adverse events as asesed(At any time during the follow-up (up to 24 months))
研究者
Anna Cruceta
Project manager Clinical Trial Unit
Fundacion Clinic per a la Recerca Biomédica