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

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ClinicalTrials.gov Identifier: NCT01404429
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : September 5, 2014
Last Update Posted : September 16, 2014
Sponsor:
Information provided by (Responsible Party):
Varun Dhir, Postgraduate Institute of Medical Education and Research

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Methotrexate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis
Study Start Date : May 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change in the DAS28-3 (Disease Activity Score Using 28 Joints and Using 3 Variables) - Difference Between This Score at 12 Weeks and This Score at Baseline [ Time Frame: 12 weeks ]
    DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity

  2. Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Proportion of Patients Who Withdrew Because of Any Cause [ Time Frame: 3 months ]
  2. Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU) [ Time Frame: 3 months ]
  3. Proportion Who Withdrew Due to Intolerance [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01404429


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Varun Dhir, Assistant Professor, Internal Medicine, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01404429    
Other Study ID Numbers: NKG/992
First Posted: July 28, 2011    Key Record Dates
Results First Posted: September 5, 2014
Last Update Posted: September 16, 2014
Last Verified: September 2014
Keywords provided by Varun Dhir, Postgraduate Institute of Medical Education and Research:
Rheumatoid arthritis
Active
Additional relevant MeSH terms:
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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
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