[18F]Fluoride PET-CT imaging for detection and monitoring of bone formation in spondyloarthritis

Recruiting

• Conditions: arthritis of the back; Spondyloartritis; 10003816; 10023213

• Registration Number: NL-OMON52517
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 48

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

• 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: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our main endpoint is data collection of the baseline and follow up<br /><br>[18F]Fluoride whole body PET-CT scans from 40 SpA patients. Clinical response<br /><br>to treatment in follow-up assessmenst will be the gold standard.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Our secondary endpoint is the histological staining of samples taken by<br /><br>PET-guided bone biopsies from 8 clinically active AS patients.</p><br>