Status:
COMPLETED
Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01404429
Start Date
May 1 2011
End Date
July 1 2012
Last Update
September 16 2014
Active Locations (1)
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1
New OPD Block, Rheumatology Clinic, Level 3
Chandigarh, Chandigarh, India, 160012