Dose reduction and withdrawal of TNF inhibitors in patients with Psoriatic Arthritis and Axial Spondyloarthritis

Phase 1

• Conditions: Adults diagnosed with Psoriatic Arthritis en Axial Spondyloarthritis.; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-003432-72-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-13
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

- 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

Exclusion Criteria

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified