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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38794
Enrollment
12
Registered
2013-04-29
Start date
2013-08-02
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gewrichten ankylosing spondylitis Bechterew's disease

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. The relation between changes in [18F]-Fluoride PET-CT and clinical monitoring as well as CRP levels during anti-TNF treatment. 2. The relation between [18F]-Fluoride PET-CT outcome as tool for AS monitoring and MRI.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)