A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BGB-45035 Versus Placebo in Patients With Moderate to Severe Active Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 38
- 主要终点
- Change from baseline in Disease Activity Score - C-reactive protein (DAS28-CRP) at Week 12
研究概览
简要总结
This study aims to evaluate the efficacy of BGB-45035 in adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying antirheumatic drugs (bDMARDs)/targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).
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
- •Diagnosed with rheumatoid arthritis (RA) based on American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for at least 3 months prior to screening
- •Demonstrated an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) (Hydroxychloroquine, methotrexate [MTX], leflunomide, or sulfasalazine) or 1 biologic disease-modifying antirheumatic drug (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) treatment
- •Must be on stable dose of one of the following permitted therapies for ≥ 4 weeks prior to screening and during the study: methotrexate between 7.5 mg to 25 mg/week, hydroxychloroquine up to 400 mg/day, leflunomide up to 20 mg/day, or sulfasalazine between 1000 mg/day to 3000 mg/day
排除标准
- •Class IV RA based on American College of Rheumatology revised criteria for classification of functional status in rheumatoid arthritis
- •Patients with a history of cancer in the last 5 years before the Screening Visit, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin
- •Have failed more than 2 b/tsDMARDs (eg, excluded if have failed 2 bDMARDs and 1 tsDMARD)
研究组 & 干预措施
BGB-45035
Participants will receive BGB-45035 orally for up to 12 weeks
干预措施: BGB-45035 (Drug)
Placebo
Participants will receive placebo orally for up to 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Disease Activity Score - C-reactive protein (DAS28-CRP) at Week 12
时间窗: Baseline and Week 12
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), high-sensitivity C-reactive protein (hsCRP in mg/L), and Patient's Global Assessment of Arthritis Pain (measured on a Visual Analog Scale \[VAS\] from 0 \[no pain\] to 100 \[worst possible pain\]). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A score greater than 5.1 indicates high disease activity, a score between 3.2 and 5.1 indicates moderate disease activity, a score between 2.6 and 3.2 indicates low disease activity, and a score less than 2.6 indicates the participant is in remission.
次要结局
- Percentage of participants with a 20% improvement in American College of Rheumatology Criteria (ACR20)(Baseline and Week 12)
- Percentage of participants with a 50% improvement in American College of Rheumatology Criteria (ACR50)(Baseline and Week 12)
- Change from baseline in Simplified Disease Activity Index (SDAI) score(Baseline up to Week 12)
- Change from baseline in Clinical Disease Activity Index (CDAI) score(Baseline up to Week 12)
- Change from baseline of Participant's global assessment of arthritis pain (VAS)(Baseline up to Week 12)
- Percentage of participants with a 20% improvement in American College of Rheumatology Criteria (ACR20)(Baseline and Week 12)
- Percentage of participants with a 50% improvement in American College of Rheumatology Criteria (ACR50)(Baseline and Week 12)
- Percentage of participants with a 70% improvement in American College of Rheumatology Criteria (ACR70)(Baseline and Week 12)
- Change from Baseline in Tender Joint Count 68 (TJC 68)(Baseline up to Week 12)
- Change from baseline in Swollen Joint Count 66 (SJC 66)(Baseline up to Week 12)
- Change from baseline in physician's global assessment of disease activity (PhGADA_VAS)(Baseline up to Week 12)
- Change from baseline in Simplified Disease Activity Index (SDAI) score(Baseline up to Week 12)
- Change from baseline in Clinical Disease Activity Index (CDAI) score(Baseline up to Week 12)
- Change from baseline of participant's global assessment of disease activity (PaGADA_VAS)(Baseline up to Week 12)
- Change from baseline of Participant's global assessment of arthritis pain (VAS)(Baseline up to Week 12)
- Change from baseline of Participant's assessment of physical function as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)(Baseline up to Week 12)
- Number of participants with adverse events (AEs)(Up to approximately 4 months)