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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Methotrexate

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