A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- Area under the curve or 'AUC' obtained by adding 0 for no response and 1 for an ACR 20 response for visits on Day 112, 140, and 168
研究概览
简要总结
A small protein called dnaJ peptide may help people with rheumatoid arthritis (RA) by preventing their immune system cells from attacking their own tissues. The purpose of this study is to determine if small amounts of dnaJ peptide can "re-educate" immune cells in people with RA so that the cells stop attacking joint tissues.
详细描述
Immune modulation is a promising new approach for the treatment of RA. Studies have shown that immune cells in the joints of people in the early stages of RA react strongly against dnaJ peptides from bacteria. These immune cells may also cross-react with human dnaJ peptides in the joints to cause inflammation. dnaJ may help RA by "re-educating" the immune system and dampening the abnormal inflammatory immune response in RA.
This study will last 7 months. Participants will be randomly assigned to receive either dnaJ or placebo by mouth. At screening, participants will have medical history, physical, and medication assessment. At screening, at 6 study visits every month after the start of treatment, and at 1 month follow-up, participants will have a joint exam, blood and urine collection, and will fill out a questionnaire about their condition.
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active rheumatoid arthritis as defined by the revised American College of Rheumatology (ACR) 1987 criteria. Evidence of active disease will be based on at least six swollen or nine tender joints.
- •Diagnosis of rheumatoid arthritis of less than 5 years
- •Reactivity to dnaJ
- •Agree to use acceptable methods of contraception
- •Able to understand and sign informed consent
排除标准
- •Patients taking more 7.5 mg of prednisone or disease modifying agents other than hydrochloroquine or sulfasalazine (i.e., gold, penicillamine, azathioprine, cyclophosphamide, methotrexate, cyclosporine, or anti-TNF agents)
- •Serum creatinine greater than 1.5 mg/dl
- •SGOT less than SGPT
- •Alkaline phosphatase greater than 2 times age/sex adjusted normal values
- •Hematocrit of less than 30
- •Platelets less than 130,000
- •History of lymphoma
- •Any active malignancy or cancer requiring treatment in the last 5 years, except for nonmelanoma skin cancers and carcinoma of the cervix in situ
- •Medical or psychiatric condition or active serious infection
- •Pregnant or breastfeeding
研究组 & 干预措施
A
Subjects randomized to arm A received 25mg/day po of placebo
干预措施: None-placebo (Drug)
B
Subjects randomized to Arm B received 25mg/day po of peptide dnaJP1
干预措施: dnaJ peptide (Drug)
结局指标
主要结局
Area under the curve or 'AUC' obtained by adding 0 for no response and 1 for an ACR 20 response for visits on Day 112, 140, and 168
时间窗: time points 112, 140 and 168 of the 6-month trial
次要结局
- Day 112 ACR 20 score(Visit day 112 of the 6-month trial)