A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody (HuMax-CD4) in Patients With Active Rheumatoid Arthritis Failing Treatment With Methotrexate and TNF-alpha Blocking Agents
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Genmab
- 入组人数
- 83
- 试验地点
- 52
- 主要终点
- Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
研究概览
简要总结
The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active RA in participants who have failed treatment with MTX and at least one TNF-alpha blocking agent.
详细描述
This is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of HuMax-CD4 in the treatment of participants with active RA who have failed treatment with MTX and at least one TNF-alpha blocking agent. Participants are randomized to receive one of two doses of HuMax-CD4 or placebo. The drug will be administered as a subcutaneous infusion (given just under the skin), more often in the beginning and then followed by a maintenance dose. There is a 4 week follow up period, and the final evaluation of the clinical endpoints takes place 26 weeks after treatment start. The trial lasts about 28 weeks in all.
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
- •A diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 revised criteria (ACR) of at least 6 months duration.
- •Active disease at the time of screening.
- •Failure to tolerate MTX, or lack of efficacy after a minimum of 6 months treatment with MTX.
排除标准
- •Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary Sjögren's disease).
- •Syndromes such as Fibromyalgia which require chronic pain treatment.
- •Most past or current cancers.
- •Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest, nasal or throat infections, tuberculosis, hepatitis B and C.
- •History of infected joint prosthesis within 5 years.
- •Most active medical conditions such as heart disease, kidney disease, liver disease, blood diseases, hormonal disturbances, lung disease, psychiatric disease.
- •Drug or alcohol abuse.
- •Pregnant or breast-feeding women may not participate. Women of childbearing potential must use either contraceptive pills or an intra-uterine device for the entire study period.
- •Note: Other protocol defined Inclusion and Exclusion criteria may apply.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
HuMax-CD4 80 milligrams (mg)
干预措施: Humax-CD4 (Drug)
HuMax-CD4 160 mg
干预措施: Humax-CD4 (Drug)
结局指标
主要结局
Change from Baseline in Erythrocyte Sedimentation Rate (ESR)
时间窗: Baseline up to Week 26
Change from Baseline in Disease Activity Score (DAS)
时间窗: Baseline up to Week 26
Change from Baseline in SFP-36 questionnaire at Week 10 and 26
时间窗: Baseline, Week 10 and Week 26
Number of Participants with Adverse Events (AEs)
时间窗: Day 1 up to end of study (Week 26)
Number of Participants with American College of Rheumatology (ACR) 20 Response
时间窗: At Week 14 and Week 18
Change from Baseline in C-Reactive Protein (CRP)
时间窗: Baseline up to Week 26
次要结局
- Number of Participants With Clinically Significant Laboratory Abnormalities(Up to 26 weeks)
- Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres(Up to 26 weeks)