Detection and monitoring of effects of biological therapy on bone formation in patients with Bechterew's disease or psoriatic arthritis with the use of a Positron Emission Tomography (PET) scan.
- Conditions
- Spondyloarthritis (ankylosing spondylitis and psoriatic arthritis)Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2017-004850-40-NL
- Lead Sponsor
- VU Medical Center, department of Rheumatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 48
• 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
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
•Treatment with any investigational drug within the previous 3 months.
•Pregnancy or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method