drugset / Trial / NCT01216631

Seronegative Oligoarthritis of the Knee Study (SOKS)

NCT01216631

Phase 2 Terminated 1 enrolled University of Leeds Centocor, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study is to establish the efficacy and duration of effect of intra-articular (IA) infliximab vs intravenous infliximab vs current standard care (IA steroid injections) in seronegative oligoarthritis. All patients will have seronegative arthritis affecting less than 5 joints but including at least one knee. 10 patients will receive IA infliximab injections to the affected knee, 10 will receive IA steroid injections to the affected knee and 10 will receive a course of intravenous infliximab. Patients will not be aware of their group as this is a placebo-controlled study.

Timeline

Start
2010-09
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 5 mg/kg Other
Subject Infliximab Monoclonal antibody 100 mg Other
Comparator Methylprednisolone Other / unclassified 80 mg Other

Indications