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

NCT ID: NCT00579644

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-28
• Study Completion Date: 2006-05-31

Brief 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

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Combination of Minocycline and MTX or MTX alone

Intervention Type: DRUG

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

2 Methotrexate

Methotrexate Dosing:

1. Initial evaluation: The dose of methotrexate for all patients will be 10 mg/week.

2. 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.

3. 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.

4. 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

5. 12 month evaluation: End of the blinded portion of the study.

Group Type: ACTIVE_COMPARATOR

methotrexate

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Rheumatrex®; Trexall®; Dynacin®; Minocin®; Myrac®; Rheumatrex®; Trexall®

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James R O'Dell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0519-00 FB

Identifier Type: -

Identifier Source: org_study_id