NL-OMON23538
Recruiting
Not Applicable
[18F]Fluoride PET-CT imaging for detection and monitoring of bone fomration in spondyloarthritis
ovartis, Foreum, Pfizer0 sites48 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankylosing spondylitis, psoriatic arthritis
- Sponsor
- ovartis, Foreum, Pfizer
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- Prior Treatment with anti\-IL\-17 (for Secukinumab starters)
- •\- Treatment with any investigational drug within the previous 3 months.
- •\- Pregnancy or breast\-feeding
Outcomes
Primary Outcomes
Not specified
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