Inflammatory knee mono-arthritis MedDRA version: 8.1 Level: LLT Classification code 10062164 Term: Seronegative arthritis
Conditions
Interventions
Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder and solvent for solution for infusion
Sponsors
St Georges Healthcare NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed