NL-OMON29006CompletedNot Applicable
Randomised controlled trial of dose reduction and withdrawal strategies of TNF inhibitors in Psoriatic Arthritis and Axial Spondyloarthritis.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sint Maartenskliniek
- Enrollment
- 95
Study Overview
Brief Summary
Michielsens, C.A.J., Boers, N., den Broeder, N. et al. Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial. Trials 21, 90 (2020). https://doi.org/10.1186/s13063-019-4000-5
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Eligible patients are = 16 years of age at the time of signing the informed consent form AND
- •1) have peripheral SpA of the psoriatic arthritis subtype diagnosed clinically by the rheumatologist , supported by the Classification Criteria for Psoriatic Arthritis (CASPAR) and/or
- •2) have axial SpA of the axial spondyloarthritis subtype, supported by the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, AND
- •- Are using full dose, or at least > 50% of the authorized defined daily dose (DDD), of an originator or biosimilar TNFi (adalimumab, certolizumab, etanercept, golimumab, infliximab);
- •- Patients have to have stable LDA, Psoriatic Arthritis Disease Activity Score (PASDAS) = 3.2 and a skin measure of body surface area involvement (modified BSA) using a target of 3% as used by rheumatologists in clinical practice for PsA and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 and an absence of active extra-axial 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 patient.
Exclusion Criteria
- •- Previous recorded unsuccessful dose reduction of TNFi in the previous 24 months,
- •- 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)
Investigators
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