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

VU Medical Center, department of Rheumatology0 sites48 target enrollmentFebruary 28, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Spondyloarthritis (ankylosing spondylitis and psoriatic arthritis)
Sponsor: VU Medical Center, department of Rheumatology
Enrollment: 48
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

February 28, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

VU Medical Center, department of Rheumatology

•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
•oIn 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