drugset / Trial / NCT01308255

Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

NCT01308255

Phase 4 Completed 112 enrolled University of Leeds
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a placebo controlled randomised clinical trial.Patients attending Yorkshire Early Arthritis Clinics and diagnosed with rheumatoid arthritis with symptom duration of 3-12 months will be recruited. They will be randomised to blinded therapy with either methotrexate and intravenous corticosteroid at baseline, or methotrexate and intravenous infliximab according to the standard treatment regime. Patients will be followed regularly, and at each visit, if the patients are not in remission, they will be given an intramuscular injection of corticosteroid. After 26 weeks, all patients will be unblinded and those with an inadequate treatment response will be treated according to a dose escalation algorithm until they achieve remission. Those in remission will continue on blinded therapy and if 6 months of remission is achieved the intravenous agent (infliximab or placebo) will be withdrawn.

Timeline

Start
2006-09
Primary completion
2011-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 3 mg/kg Intravenous
Comparator Methylprednisolone Other / unclassified 120 mg Intravenous
Comparator Methylprednisolone Other / unclassified 250 mg Intravenous
Background Methotrexate Small molecule 20 mg Oral

Indications