Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Remission evaluated by American College of Rheumatology (ACR) outcome variables
研究概览
简要总结
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis
详细描述
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis (RA). Specific aims of this study are:
A. To demonstrate that the combination of minocycline and methotrexate is well tolerated when used in the first year of RA.
B. To compare the efficacy of the combination of minocycline and methotrexate with methotrexate and placebo therapy in early sero-positive RA patients.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over or equal to 19 years old and less than or equal to 75 years old
- •Diagnosis of RA as determined by fulfilling 4 of 7 ACR criteria
- •Positive rheumatoid factor
- •Duration of disease: greater than six weeks and less than one year
排除标准
- •Allergy to tetracycline or methotrexate
- •Previous DMARD treatment
- •Doses of oral steroids greater than 7.5 mg/day
- •Intra-articular injections within the last four weeks
- •Significant liver or renal disease or active peptic ulcer disease
- •Patients who are not willing to abstain from alcohol consumption
- •Women of childbearing potential who are not practicing a successful method of contraception
研究组 & 干预措施
1 Methotrexate* & minocycline
Methotrexate Dosing:
1)initial dose of methotrexate for all patients will be 10 mg/week. 2)2 month: dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, increased to 15 mg/week.
3)4 month: dose of MTX will remain at its current level if full remission criteria are met; otherwise, be increased to 20 mg/week.
4)6, 8 and 10 month: If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week,dose will be increased to 20 mg/week. If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month 5)12 month evaluation: End of the blinded portion of the study. minocycline dosage 200 mg
干预措施: Combination of Minocycline and MTX or MTX alone (Drug)
2 Methotrexate
Methotrexate Dosing:
- Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week.
- 2 month evaluation: The dose of MTX will remain at 10 mg/week if full remission criteria are met; otherwise, it will be increased to 15 mg/week.
- 4 month evaluation: The dose of MTX will remain at its current level if full remission criteria are met; otherwise, it will be increased to 20 mg/week.
- 6, 8 and 10 month evaluations:
- If the patient has fallen below full remission criteria and is not already receiving the maximum dose of 20 mg/week, the dose will be increased to 20 mg/week.
- If the patient meets ACR 50 criteria prednisone will be tapered by 1mg/month
- 12 month evaluation: End of the blinded portion of the study.
干预措施: methotrexate (Drug)
结局指标
主要结局
Remission evaluated by American College of Rheumatology (ACR) outcome variables
时间窗: 48 weeks
Patients will be evaluated and then at 2-month intervals to 12 months using the ACR core set of outcome variables (50) for remission. Additionally hand x-rays will be done.
次要结局
- Comparison of combination therapy versus methotrexate alone, Composite Index(48 weeks)