drugset / Trial / NCT01295151

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

NCT01295151

Phase 4 Completed 122 enrolled Julia Brown
RandomizedParallel-groupOpen-labelTreatment

Summary

The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.

Timeline

Start
2011-08
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 500 mg Intravenous
Subject Abatacept Other / unclassified 750 mg Intravenous
Subject Abatacept Other / unclassified 1000 mg Intravenous
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Certolizumab Pegol Protein / enzyme biologic 200 mg Subcutaneous
Subject Etanercept Protein / enzyme biologic 50 mg Subcutaneous
Subject Golimumab Monoclonal antibody 50 mg Subcutaneous
Subject Infliximab Monoclonal antibody 3 mg/kg Intravenous
Comparator Rituximab Monoclonal antibody 1000 mg Intravenous

Indications