[18F]Fluoride PET-CT imaging for detection and monitoring of bone fomration in spondyloarthritis
- Conditions
- Ankylosing spondylitis, psoriatic arthritis
- Registration Number
- NL-OMON23538
- Lead Sponsor
- ovartis, Foreum, Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
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.
- Prior Treatment with anti-IL-17 (for Secukinumab starters)
- Treatment with any investigational drug within the previous 3 months.
- Pregnancy or breast-feeding
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Our secondary endpoint is the histological analysis of samples taken by PET-guided bone biopsies from 8 clinically active AS patients.