A prospective observational cohort study of intra-articular Infliximab in knee mono-arthritis - Intra-articular Infliximab in knee mono-arthritis

Phase 1

• Conditions: Inflammatory knee mono-arthritis; MedDRA version: 8.1 Level: LLT Classification code 10062164 Term: Seronegative arthritis

• Registration Number: EUCTR2006-001448-29-GB
• Lead Sponsor: St Georges Healthcare NHS trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Study Completion: 2012-01-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Sero-negative inflammatory knee mono-arthritis, including psoriatic, enteropathic, reactive and undifferentiated seronegative spondyloarthropathy (SpA).
2.Age range 18 – 80
3.Active disease despite concomitant treatment with one of the following DMARDs as monotherapy, with no dose change for the preceding 8 weeks (2 months):
Sulphasalazine (2g – 3g daily up to maximum tolerated dose)
Methotrexate (7.5 – 20 mg weekly up to maximum tolerated dose)
Leflunomide (10 – 20mg daily up to maximum tolerated dose)
Ciclosporin (2.5 mg/kg body weight)
Where no DMARD has been co-prescribed Sulphasalazine will be started at 500 mg b.d. for a week and then increased to 1g b.d. for a further 8 weeks before entry criteria are re-assessed.
4.Active disease defined as
i)composite knee score 4 or more (21)
ii)VAS score > 5 for pain on walking and on ascending/descending stairs
iii)evidence of synovial vascularity on PDS (score 2 or 3) in views obtained from either the suprapatellar fossa, lateral or medial parapatellar spaces (18).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Inability to tolerate DMARD monotherapy
2.Systemic corticosteroid therapy
3.Systemic or intra-articular anti-TNF alpha or other biologic therapy within the preceding 3 months.
4.Knee aspiration or intra-articular corticosteroid, yttrium or osmic acid injection within the preceding 3 months
5.Arthroscopic lavage or other operative procedure within the preceding 3 months
6.Established contra-indications to anti-TNF alpha therapies (e.g. chronic infectious diseases) or previous intolerance to Infliximab

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine clinical and ultrasound (power doppler) predictors of response to intra-articular Infliximab therapy in patients with persistent inflammatory mono-arthritis of the knee in a prospective observational cohort.;Secondary Objective: ;Primary end point(s): The primary measure of treatment efficacy will be determined by a fall in PDS score to 0 or 1 in all 3 regions of the knee (suprapatellar fossa, lateral and medial parapatellar spaces) within 12 weeks of the injection of Infliximab (23). Secondary measures of efficacy will be an improvement in clinical measures, i.e. composite knee score of 2 or less and a reduction in VAS scores to 2 or less within 12 weeks. The proportion of patients achieving efficacy according to PDS and each clinical measure will be recorded at weeks 2, 4, 8 and 12.