MedTrace Logo

Seronegative Oligoarthritis of the Knee Study (SOKS)

NCT01216631 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-05-13

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Centocor, Inc.

    collaborator INDUSTRY

  • University of Leeds

    lead OTHER

Principal Investigators

  • Philip G Conaghan, FRCP · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216631 on ClinicalTrials.gov