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Completed

NCT Number: NCT00579644

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

The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combination of Minocycline and MTX or MTX alone

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

Other names: Rheumatrex®, Trexall®, Dynacin®, Minocin®, Myrac®

methotrexate

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.

Other names: Rheumatrex®, Trexall®

Primary outcomes

  1. Remission evaluated by American College of Rheumatology (ACR) outcome variables

    Time frame: 48 weeks

    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.

Secondary outcomes

  1. Comparison of combination therapy versus methotrexate alone, Composite Index

    Time frame: 48 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Dec 24, 2007
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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