A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- American College of Rheumatology 20 Response (ACR20)
研究概览
简要总结
This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo
- •Be receiving either: Oral (tablets) or subcutaneous (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, etc).
- •Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.
研究组 & 干预措施
1
干预措施: Etanercept (Drug)
2
20mg
干预措施: AZD5672 (Drug)
3
50mg
干预措施: AZD5672 (Drug)
4
100mg
干预措施: AZD5672 (Drug)
5
150mg
干预措施: AZD5672 (Drug)
6
干预措施: Placebo (Drug)
结局指标
主要结局
American College of Rheumatology 20 Response (ACR20)
时间窗: 12 weeks
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 12 Weeks' treatment.
次要结局
- American College of Rheumatology 50 Response (ACR50)(12 weeks)
- American College of Rheumatology 70 Response (ACR70)(12 weeks)
- Disease Activity Score (Based on 28 Joint Count) (DAS28)(Baseline to 12 Weeks)
- Health Assessment Questionnaire - Disability Index (HAQ-DI)(Baseline to 12 Weeks)