drugset / Trial / NCT01870128

Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial

NCT01870128

Phase 3 Completed 60 enrolled All India Institute of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Methods: This is a randomized open-labeled trial. Patients were randomised into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.

Timeline

Start
2009-08
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydroxychloroquine Small molecule 200 mg
Comparator Methotrexate Small molecule 15 mg Oral
Comparator Methotrexate Small molecule 25 mg Oral
Subject Methylprednisolone Other / unclassified 1000 mg Intravenous
Comparator Sulfasalazine Small molecule 2000 mg
Comparator Sulfasalazine Small molecule 3000 mg

Indications