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

NCT00579644 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 0519-00 FB
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of combination therapy versus methotrexate alone, Composite Index

  48 weeks

Study Arms (2)

1 Methotrexate* & minocycline

ACTIVE COMPARATOR

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

2 Methotrexate

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Rheumatrex®, Trexall®, Dynacin®, Minocin®, Myrac®

1 Methotrexate* & minocycline

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.

Also known as: Rheumatrex®, Trexall®

2 Methotrexate

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; Minocycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• James R O'Dell, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: March 28, 2001
• Primary Completion: May 31, 2006
• Study Completion: May 31, 2006
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

US (1)