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Completed

NCT Number: NCT01404429

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New OPD Block, Rheumatology Clinic, Level 3

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

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 names: MEXATE

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis

Acronym: DMIRA

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 28, 2011
Registry last updated
Sep 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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