Ankylosing spondylitis, psoriatic arthritis
Conditions
Interventions
None listed
Sponsors
Novartis, Foreum, Pfizer
Eligibility
Inclusion criteria
Inclusion criteria: Patients must be at least 18 years of age. - Diagnosis of psoriatic arthritis according to the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) or ankylosing spondylitis according to the modified New York criteria - Patients with clinically active disease as assessed by a physician; - In PsA defined as clinically active disease with at least one clinically active enthesitis site and a clinical indication to start with Secukinumab. - In AS defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 or higher and a clinical indication to start with Secukinumab. - Treatment with disease modifying anti-rheumatic drugs (DMARDS) and non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion and during the study up to 12 weeks of follow up. - Treatment with oral corticosteroids up to 10mg daily is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion and during the study up to 12 weeks of follow up. The anti-TNF control PsA group: prior treatment with one anti-TNF is permitted, given that the patient was intolerant for this anti-TNF (no primary failure) - The AS biopsy group: start or treatment with either biological, NSAID and/or DMARD therapy is permitted. Patients must be able to adhere to the study appointments and other protocol requirements. - Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.
Exclusion criteria
Exclusion criteria: - Prior Treatment with anti-IL-17 (for Secukinumab starters) - Treatment with any investigational drug within the previous 3 months. - Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our main endpoint is [18F]Fluoride uptake changes on whole body PET-CT scans during treatment of 40 SpA patients in relation to clinical follow-up of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Our secondary endpoint is the histological analysis of samples taken by PET-guided bone biopsies from 8 clinically active AS patients. | — |
Contacts
Public ContactJerney de Jongh
VUmc
Outcome results
None listed