NCT01225393已完成2 期
A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active 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
- 入组人数
- 211
- 主要终点
- Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR
研究概览
简要总结
This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening
- •Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both
- •Active disease, defined as: CRP >= 1.0 mg/dL; swollen joint count >= 6 (66 joint count); tender joint count >= 6 (68 joint count)
- •Previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU)
- •For patients currently receiving corticosteroids: Treatment at a stable dose during last 4 weeks prior to screening
- •For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening
- •For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose
- •For patients of reproductive potential (males and females): Willing to use a highly effective birth control method for the duration of the study according to local guidelines
排除标准
- •Pregnant, planning to become pregnant during the study, or breastfeeding
- •Clinically significant abnormal laboratory values or abnormal ECG or vital signs
- •History of anaphylactic reactions
- •Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome), however patients with secondary Sjogren's syndrome are eligible for the study
- •History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome)
- •Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis
- •Administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study
- •Previous treatment with anti-TNF biologics or other biologic agents, including anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g. tocilizumab), or T cell-directed therapy (e.g. abatacept)
研究组 & 干预措施
A
Experimental
干预措施: leflunomide (Drug)
A
Experimental
干预措施: methotrexate (Drug)
B
Active Comparator
干预措施: adalimumab (Drug)
B
Active Comparator
干预措施: leflunomide (Drug)
A
Experimental
干预措施: MLTA3698A (Drug)
B
Active Comparator
干预措施: methotrexate (Drug)
B
Active Comparator
干预措施: placebo (Drug)
C
Placebo Comparator
干预措施: leflunomide (Drug)
C
Placebo Comparator
干预措施: methotrexate (Drug)
C
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR
时间窗: Day 85
Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A
时间窗: Length of study (through Day 85)
次要结局
- ACR20 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 20% responder criteria [ACR20] for their average response )(Day 85)
- ACR70 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 70% responder criteria [ACR70] for their average response)(Day 85)
- ACR50 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 50% responder criteria [ACR50] for their average response )(Day 85)
- Tender joint count(Day 85)
- Swollen joint count(Day 85)
- Investigator Global Assessment of Disease Activity(Day 85)
- Patient Global Assessment of Pain and Disease Activity(Day 85)
- Health Assessment Questionnaire Disability Index(Day 85)
- Patient's Global Health or Short Form Health Survey (SF-36)(Day 85)
- European League Against Rheumatism response rate(Day 85)
- Serum C-reactive protein levels(Day 85)
- Erythrocyte sedimentation rate(Day 85)
研究者
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