Spondyloarthritis (ankylosing spondylitis and psoriatic arthritis)
Conditions
Interventions
Product Name: [18F]Fluoride
Pharmaceutical Form: Solution for injection
Sponsors
VU Medical Center, department of Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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; 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. • Prior treatment with one anti-TNF agent is permitted with the exception of the anti-TNF control PsA group: they will have no prior anti-TNF treatment and have a clinical indication to start anti-TNF treatment. • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatment with any investigational drug within the previous 3 months. • Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim is to investigate the therapeutic effects of Secukinumab on bone formation in SpA patients by using [18F]Fluoride PET-CT imaging. ;Secondary Objective: To investigate cellular and molecular pathology in bone formation.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: One year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Our secondary endpoint is the histological staining of samples taken by PET-guided bone biopsies from 8 clinically active AS patients.;Timepoint(s) of evaluation of this end point: One year. | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
VU Medical Center, department of Rheumatology
Outcome results
None listed