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

St Georges Healthcare NHS trust0 个研究点目标入组 0 人开始时间: 2006年9月18日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•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

•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

发起方