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Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis (DMIRA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Varun Dhir, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01404429
First received: July 26, 2011
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2 weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy) versus the adverse effects.

Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Methotrexate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Mean fall in the DAS28-3 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Patients with good response (final DAS28-3 less than 3.2 and fall more than 1.2) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who withdrew because of any cause [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Proportion requiring stoppage/decrease/inability to hike MTX due to cytopenia or transaminitis (SGOT or SGPT more than 80IU) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Proportion who withdrew due to intolerance [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methotrexate 7.5 mg per week Drug: Methotrexate
Different doses for both arms followed by similar escalation (2.5 mg every 15 d) till max of 25 mg per week or 3 months completed
Other Name: MEXATE
Experimental: Methotrexate 15 mg per week Drug: Methotrexate
Different doses for both arms followed by similar escalation (2.5 mg every 15 d) till max of 25 mg per week or 3 months completed
Other Name: MEXATE

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria
  • Between 18 years to 65 year of age
  • Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1
  • Not on methotrexate in the last 2 months
  • Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day
  • Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization

Exclusion Criteria:

  • Pregnant/Breastfeeding
  • Ongoing/Recent treatment with methotrexate (2 months)
  • Chronic liver disease
  • Renal failure
  • Any leucopenia or thrombocytopenia
  • Breast-feeding
  • Desirous of pregnancy in the next 6 months
  • Known Hepatitis B or C positive
  • Known clinically relevant chronic lung disease: ILD
  • Tuberculosis or other active infections
  • Known HIV positive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404429

Locations
India
New OPD Block, Rheumatology Clinic, Level 3
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
  More Information

No publications provided

Responsible Party: Varun Dhir, Assistant Professor, Internal Medicine, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01404429     History of Changes
Other Study ID Numbers: NKG/992
Study First Received: July 26, 2011
Last Updated: August 1, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
Rheumatoid arthritis
Active

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 19, 2013