Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone

Launched by UNIVERSITY OF NEBRASKA · Dec 21, 2007

Keywords

ClinConnect Summary

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.

Gender

ALL

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