Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Unversity of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1 Methotrexate* & minocycline
2 Methotrexate
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
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.