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

Rheumatoid Arthritis Clinical Trial

Official title:

Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579644
• Other study ID #: 0519-00 FB
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2001
• Est. completion date: May 31, 2006

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

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