search
Back to results

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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Combination of Minocycline and MTX or MTX alone
methotrexate
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unversity of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 Methotrexate* & minocycline

2 Methotrexate

Arm Description

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 Dosing: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2007
Last Updated
October 3, 2023
Sponsor
University of Nebraska
search

1. Study Identification

Unique Protocol Identification Number
NCT00579644
Brief Title
Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone
Official Title
Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2001 (Actual)
Primary Completion Date
May 31, 2006 (Actual)
Study Completion Date
May 31, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Methotrexate* & minocycline
Arm Type
Active Comparator
Arm Description
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
Arm Title
2 Methotrexate
Arm Type
Active Comparator
Arm Description
Methotrexate Dosing: 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
Intervention Name(s)
Combination of Minocycline and MTX or MTX alone
Other Intervention Name(s)
Rheumatrex®, Trexall®, Dynacin®, Minocin®, Myrac®
Intervention Description
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
Intervention Name(s)
methotrexate
Other Intervention Name(s)
Rheumatrex®, Trexall®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Remission evaluated by American College of Rheumatology (ACR) outcome variables
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Comparison of combination therapy versus methotrexate alone, Composite Index
Description
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.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R O'Dell, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs