CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Methotrexatedrug
Likely dose
Methotrexate 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01404429
NCT01404429Phase 4Completed
CompareCT.gov

Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis

Post Graduate Institute of Medical Education and Research, Chandigarh·interventional·Posted Jul 28, 2011·Updated Sep 16, 2014

In Brief

A Phase 4 clinical trial evaluating Methotrexate for Rheumatoid Arthritis. Completed, enrolled 100 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2011
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.9 years ago

Interventions

Methotrexatedrug

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