Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone
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Purpose
The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Combination of Minocycline and MTX or MTX alone Drug: methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone |
- Patients will be evaluated and then at 2-month intervals to 12 months using the ACR core sent of outcome variables (50) as detailed in Appendix II, Part A. Additionally hand x-rays will be done. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Another clinically relevant comparison of the effectiveness of combination therapy versus methotrexate alone will be improvement by 20% and/or 70% by the ACR composite index. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2001 |
| Study Completion Date: | May 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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 |
Drug: Combination of Minocycline and MTX or MTX alone
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 Other Names:
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Active Comparator: 2
Methotrexate Dosing:
|
Drug: methotrexate
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. Other Names:
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | James O'Dell, MD Principal Investigator, University of Nebraska Medical Center |
| ClinicalTrials.gov Identifier: | NCT00579644 History of Changes |
| Other Study ID Numbers: | 519-00 FB |
| Study First Received: | December 18, 2007 |
| Last Updated: | January 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Minocycline Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013