NCT01008852已完成2 期
Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate
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
- Pfizer
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Response as measured by American College of Rheumatology criteria (ACR 20 response)
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.
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
- •Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
- •Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
- •Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
- •Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)
排除标准
- •Any significant health problem other than rheumatoid arthritis
- •Any clinically significant laboratory abnormalities
- •Any prior use of B cell-depleting therapy
研究组 & 干预措施
Treatment Group 5
Placebo Comparator
干预措施: Placebo (Drug)
Treatment Group 1
Experimental
干预措施: SBI-087 (Drug)
Treatment Group 2
Experimental
干预措施: SBI-087 (Drug)
Treatment Group 3
Experimental
干预措施: SBI-087 (Drug)
Treatment Group 4
Experimental
干预措施: SBI-087 (Drug)
结局指标
主要结局
Response as measured by American College of Rheumatology criteria (ACR 20 response)
时间窗: 16 weeks
次要结局
- ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response(up to 24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01011868Boehringer Ingelheim494
已完成
1 期
Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid ArthritisRheumatoid ArthritisNCT00641225Pfizer60
已完成
1 期
Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid ArthritisArthritis, RheumatoidNCT00815906Pfizer20
Unknown
3 期
Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a SulfonylureaType 2 DiabetesNCT01257334Taipei Medical University WanFang Hospital1,390
已完成
3 期
Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01177813Boehringer Ingelheim986