Randomised controlled trial of dose reduction and withdrawal strategies of TNF inhibitors in Psoriatic Arthritis and Axial Spondyloarthritis.Dose REduction Strategy Study of TNF inhibitors in Psoriatic arthritis and axial Spondyloarthritis patients: DRESS-PS.” - Dose reduction and withdrawal strategies of TNF inhibitors in PsA and axSpA.

Sint Maartenskliniek0 个研究点目标入组 234 人开始时间: 2018年9月13日最近更新: 2021年7月21日

适应症

试验速览

暂无简介。

•- Patients are > 18 years of age AND
•- Fulfil the Classification Criteria for Psoriatic Arthritis (CASPAR) and have peripheral SpA of the psoriatic arthritis subtype diagnosed clinically by the rheumatologist and/or fulfil the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA AND
•- Are using full dose, or at least > 50% of the authorized defmed daily dose (DDD), of an origmator or biosimilar TNFi (adalimumab, certolizumab, etanercept, golimumab, infliximab) AND
•- Patients have to have stable LDA, Psoriatic Arthritis Disease Activity Score (PASDAS) s 3 2 and a skin measure of Body Surface Area mvolvement (modified BSA) using a target of 3% as used by rheumatologists in climcal practice for PsA and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2 1 and an absence of active extra-articular symptoms such as Crohn’s disease, uveitis, colitis or psoriasis for axSpA, for at least 6 months, or when formal measurements are not available, judgement of physician and patiënt
•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 187
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 47

•- Previous recorded unsuccessful dose reduction of TNFi,
•- Comorbidities expected to hamper successful dose reduction (e g Crohns disease, Ulcerative colitis, Psoriasis, Uveitis),
•- Not able to have 12 months follow-up (life expectancy, planned relocation),
•- Not able to measure outcome (language, other limitations)

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