arthritis of the back Spondyloartritis
Conditions
Interventions
Patients will receive a PET-CT scan at baseline (before start of Secukinumab or
anti-TNF treatment) and a PET-CT scan after 12 weeks of treatment.
Additionally, a group of 8 patients included in the
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of psoriatic arthritis according to the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) or ankylosing spondylitis according to the ASAS criteria • Patients with clinically active disease as assessed by a physician; o In PsA defined as clinically active disease with at least one clinically active enthesitis site and a clinical indication to start with Secukinumab o 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 with either biological or NSAID 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 data collection of the baseline and follow up [18F]Fluoride whole body PET-CT scans from 40 SpA patients. Clinical response to treatment in follow-up assessmenst will be the gold standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| Our secondary endpoint is the histological staining of samples taken by PET-guided bone biopsies from 8 clinically active AS patients. | — |
Countries
Netherlands
Outcome results
None listed