Rheumatoid Arthritis Clinical Trial
Official title:
Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone
Verified date | October 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis
Status | Completed |
Enrollment | 91 |
Est. completion date | May 31, 2006 |
Est. primary completion date | May 31, 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Unversity of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Remission evaluated by American College of Rheumatology (ACR) outcome variables | 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. | 48 weeks | |
Secondary | Comparison of combination therapy versus methotrexate alone, Composite Index | Clinically relevant comparison of the effectiveness of combination therapy versus methotrexate alone will be improvement by 20% and/or 70% by the American College of Rheumatology composite index. | 48 weeks |
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