drugset / Trial / NCT00858780

Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA

NCT00858780

Phase 4 Completed 91 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.

Timeline

Start
2009-01
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etanercept Protein / enzyme biologic 25 mg
Comparator Etanercept Protein / enzyme biologic 50 mg
Background Methotrexate Small molecule

Indications