NCT01010581已完成2 期
A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 4SC AG
- 入组人数
- 266
- 试验地点
- 27
- 主要终点
- Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA
研究概览
简要总结
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of SC12267 (4SC-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the treatment of patients suffering from Rheumatoid Arthritis.
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
- Double (Participant, Investigator)
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 active RA of functional classes I, II or III according to the criteria of American Rheumatism Association for RA
- •DAS28(ESR) ≥ 4.5 (DAS28 formula with 4 variables using ESR)
- •Patients who have received weekly doses of MTX (10-25 mg/week) for a minimum of 3 months prior to Day 1 dosing, and who have received a stable MTX dose of 10-25 mg/week without any change in route or change in folic acid supplementation for at least 6 weeks prior to Day 1 dosing
- •Patients may receive up to 10 mg/day of oral prednisolone or steroid equivalent. Dose must have been stable for at least 30 days and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements
排除标准
- •Patients with RA of functional classes IV according to the criteria of American Rheumatism Association for RA
- •Patients who have received any of the following treatments must abide by the indicated washout period:
- •Leflunomide requires a 6 month washout period prior to Day 1 dosing
- •Oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to Day 1 dosing
- •Cyclosporine, abatacept, etanercept, adalimumab, infliximab, and rituximab require a 60 day washout period prior to Day 1 dosing
- •Cyclophosphamide requires a 180 day washout period prior to Day 1 dosing
- •Parenteral or intra-articular corticosteroids require a 30 day washout period prior to Day 1 dosing
- •Receipt of the following drugs within 4 weeks prior to dosing:
- •Sulfasalazine
- •Hydroxychloroquine
- •Use of corticosteroids > 10 mg/day
研究组 & 干预措施
Placebo + Methotrexate
Placebo Comparator
干预措施: Folic Acid (Drug)
SC12267 (4SC-101) + Methotrexate
Experimental
干预措施: SC12267 (4SC-101) (Drug)
SC12267 (4SC-101) + Methotrexate
Experimental
干预措施: Methotrexate (Drug)
SC12267 (4SC-101) + Methotrexate
Experimental
干预措施: Folic Acid (Drug)
Placebo + Methotrexate
Placebo Comparator
干预措施: Placebo (Drug)
Placebo + Methotrexate
Placebo Comparator
干预措施: Methotrexate (Drug)
结局指标
主要结局
Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA
时间窗: 13 weeks
次要结局
- Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA(13 weeks)
- Evaluation of the plasma concentration (trough value) of SC12267 (4SC-101) after once daily application in combination with methotrexate after once weekly administration.(13 weeks)
研究者
研究点 (27)
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