drugset / Trial / NCT00451971

Objective Study in Rheumatoid Arthritis

NCT00451971

Phase 4 Completed 249 enrolled Sanofi
RandomizedSingle-groupSingle-blindTreatment

Summary

Primary Objectives 1. To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range. 2. To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care. Secondary Objectives 1. To establish the relationship between achieving a given STO or combination of STOs and damage progression. 2. To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.

Timeline

Start
2002-03
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Leflunomide Small molecule

Indications