Assessment of disease activity of ankylosing spondylitis with [18F]Fluoride PET-CT.

Completed

Conditions: Gewrichten
ankylosing spondylitis
Bechterew's disease
10003816
10005959

Registration Number: NL-OMON38794

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Men and women, * 18 and * 70 years of age
2. Diagnosis of ankylosing spondylitis according to the modified New York criteria.
3. The BASDAI score should be * 4.
4. Patients will start with anti-TNF according to clinical care.
5. Treatment with disease modifying anti-rheumatic drugs (DMARDS) and non-steroidal anti-inflammatory drugs (NSAIDs) is permitted, provided that there is a stable dose for at least 2 weeks prior to inclusion and during the study up to 16 weeks of follow up.
6. Patients must be able to adhere to the study appointments and other protocol
requirements.
7. Patients must be capable of giving informed consent and the consent must have been
obtained prior to the study related procedures.

Exclusion Criteria

1. Treatment with any investigational drug within the previous 3 months.
2. Primary failure of anti-TNF treatment in the past.
3. Pregnancy or breast-feeding.
4. Implanted pacemaker
5. Renal failure with creatinine clearance < 30 ml/min

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. [18F]fluorid uptake in vertebral column and/or SI joints on PET-CT in AS<br /><br>patients with clinically active disease.<br /><br><br /><br>Sub-study in 2 patients:<br /><br><br /><br>2. Quality of the bone biopsy material of PET positive lesions in the vertebral<br /><br>column. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The relation between changes in [18F]-Fluoride PET-CT and clinical<br /><br>monitoring as well as CRP levels during anti-TNF treatment.<br /><br><br /><br>2. The relation between [18F]-Fluoride PET-CT outcome as tool for AS monitoring<br /><br>and MRI.</p><br>