Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone
Information source: University of Nebraska
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Combination of Minocycline and MTX or MTX alone (Drug); methotrexate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of Nebraska Official(s) and/or principal investigator(s):
James R O'Dell, MD, Principal Investigator, Affiliation: University of Nebraska
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
Clinical Details
Official title: Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: 19 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2001
Ending date: May 2006
Last updated: December 21, 2007
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