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

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ClinicalTrials.gov Identifier: NCT00579644
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : January 13, 2010
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Combination of Minocycline and MTX or MTX alone Drug: methotrexate Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone
Study Start Date : January 2001
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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:
  • Rheumatrex®
  • Trexall®
  • Dynacin®
  • Minocin®
  • Myrac®
Active Comparator: 2

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.
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:
  • Rheumatrex®
  • Trexall®


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579644


Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: James R O'Dell, MD University of Nebraska
More Information

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
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Prednisone
Minocycline
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists