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: September 5, 2014
Last verified: September 2014

July 26, 2011
September 5, 2014
May 2011
June 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01404429 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
Randomized Controlled Trial of Two Different Starting Doses of Methotrexate 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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
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
  • Active Comparator: Methotrexate 7.5 mg per week
    Intervention: Drug: Methotrexate
  • Experimental: Methotrexate 15 mg per week
    Intervention: Drug: Methotrexate
Dhir V, Singla M, Gupta N, Goyal P, Sagar V, Sharma A, Khanna S, Singh S. Randomized controlled trial comparing 2 different starting doses of methotrexate in rheumatoid arthritis. Clin Ther. 2014 Jul 1;36(7):1005-15. doi: 10.1016/j.clinthera.2014.05.063. Epub 2014 Jun 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01404429
NKG/992
No
Varun Dhir, Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
Not Provided
Not Provided
Postgraduate Institute of Medical Education and Research
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP