Dose REduction Strategy Study of TNF inhibitors in Psoriatic arthritis and axial Spondyloarthritis patients.

Completed

• Conditions: chronic inflammation of the joints; Psoriatic arthritis and axial spondyloarthritis; 10003816; 10023213

• Registration Number: NL-OMON49692
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-05-30
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 95

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in proportion of patients between T2T strategy with or without<br /><br>tapering attempt who are in LDA state (PASDAS <= 3.2 and modified BSA <= 3% of<br /><br>the skin (PsA), ASDAS < 2.1 (axSpA) and an absence of active extra-axial<br /><br>symptoms) at 12 months follow-up, compared to the prespecified non-inferiority<br /><br>margin of 0.2 (20%).</p><br>