NCT01404429

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2011-07-28
• Last updated: 2014-09-16
• Results posted: 2014-09-05

Locations

1 site across 1 country: India