A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- American College of Rheumatology 20 Response (ACR20) at 6 Months
研究概览
简要总结
The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine
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
- •Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following: documented history and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion.
- •Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation.
排除标准
- •Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c). Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. Persistently abnormal liver function enzymes (blood test).
研究组 & 干预措施
1
Etanercept 50mg, subcutaneous, once weekly
干预措施: Etanercept (Drug)
2
50mg oral, once daily
干预措施: AZD9056 (Drug)
3
100 mg oral, once daily
干预措施: AZD9056 (Drug)
4
200 mg oral, once daily
干预措施: AZD9056 (Drug)
5
400mg once, daily
干预措施: AZD9056 (Drug)
6
oral, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
American College of Rheumatology 20 Response (ACR20) at 6 Months
时间窗: 6 months
The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
次要结局
- American College of Rheumatology 50 Response (ACR50) at 6 Months(6 months)
- American College of Rheumatology 70 Response (ACR70) at 6 Months(6 months)
- Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.(Baseline to 6 months)
- Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.(Baseline to 6 months)