L40.5
Conditions
Interventions
Group 1: The start of the study is the clinically indicated switch to the following therapy: TNFi (tumor necrosis factor inhibitor). In addition, samples are taken to determine the predictive markers.
Sponsors
Ruhr-Universität Bochum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosis of active PsA (psoriatic arthritis) - No MDA status (minimal disease activity) after at least 3 months of MTX (methotrexate) treatment - Clinical indication for treatment escalation from MTX to a b-DMARD (biologic disease-modifying antirheumatic drug) - Switch to one of the following three biologic classes: TNFi (tumour necrosis factor inhibitor), IL17i (Interleukin 17 Inhibitor) and IL23i (Interleukin 23 Inhibitor)
Exclusion criteria
Exclusion criteria: - Non-response or intolerance to MTX (methotrexate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MDA (minimal disease activity): The response to therapy is measured as a binary outcome (responder/non-responder) based on whether patients achieve clinical remission 16 weeks after starting therapy with a bDMARD (biological disease-modifying antirheumatic drug). | — |
Secondary
| Measure | Time frame |
|---|---|
| • ? Current status of the state of health • ? Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) • ? Dactylitic finger/toe count • ? Disease Activity in Psoriatic Arthritis (DAPSA) • ? Enthesitis SPARCC Score • ? Health Assessment Questionaire (HAQ) • ? Leeds Enthesitis Index • ? Maastrich Ankylosing Spondylitis Enthesitis Score - (MASES) • ? Nail Psoriasis Severity Index (NAPSI) • ? Patient Accepted Symptom Status (PASS) • ? Patient global activity • ? Patient pain • ? Physician’s global assessment of PsA • ? Psoriasis area and severity index (PASI) | — |
Countries
Germany
Contacts
Public ContactXenofon Baraliakos
Rheumazentrum Ruhrgebiet
Outcome results
None listed