drugset / Trial / NCT00317538

Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept

NCT00317538

Phase 3 Completed 28 enrolled Centocor Ortho Biotech Services, L.L.C.
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study, in patients with rheumatoid arthritis who have had an incomplete response to etanercept and methotrexate (MTX), are to evaluate: safety and evidence of therapeutic benefit of infliximab and methotrexate, the levels (pharmacokinetics) of etanercept and infliximab and antibodies (immunogenicity) to etanercept and infliximab in patients blood, whether switching from etanercept to infliximab changes progression of structural damage over the study period, and whether specific markers in the blood (pharmacodynamics) correlate with therapeutic response or benefit.

Timeline

Start
2003-06
Primary completion
Completion
2004-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Etanercept Protein / enzyme biologic 25 mg Subcutaneous
Subject Infliximab Monoclonal antibody 3 mg/kg Intravenous

Indications