NCT01216631

Seronegative Oligoarthritis of the Knee Study (SOKS)

Intra-articular and Intravenous Infliximab in the Treatment of Resistant Seronegative Oligoarthritis of the Knee

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondylarthropathies

Interventions

Type	Name	Description
DRUG	methylprednisolone	intra-articular injection of methylprednisolone (80mg given at baseline only)
DRUG	Infliximab	intra-articular injection of 100mg infliximab given at baseline only
DRUG	Infliximab	intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-10-07
• Last updated: 2016-05-13
• Results posted: 2016-05-13

Locations

1 site across 1 country: United Kingdom