Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
Information source: Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Methotrexate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Postgraduate Institute of Medical Education and Research
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
Clinical Details
Official title: Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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 BaselinePatients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)
Secondary outcome: Proportion of Patients Who Withdrew Because of Any CauseProportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU) Proportion Who Withdrew Due to Intolerance
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
New OPD Block, Rheumatology Clinic, Level 3, Chandigarh 160012, India
Additional Information
published manuscript
Starting date: May 2011
Last updated: September 5, 2014
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