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To determine the value of PET/MRI for diagnosis, therapy monitoring, and prognostic value in patients with spondyloarthritis before and after initiation of various drug therapies.

To determine the value of PET/MRI for diagnosis, therapy monitoring, and prognostic value in patients with spondyloarthritis before and after initiation of various drug therapies.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025279
Enrollment
50
Registered
2023-06-13
Start date
2021-09-08
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

M45.01 Axial spondyloarthrititis M45.01

Interventions

Group 1: Biologics-naive patients undergo a baseline examination. This is followed by a control of the same arm after 3-6 months. No control arm available.

Sponsors

Rheumazentrum Ruhrgebiet
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of spondyloarthritis (radiographic or nonradiographic axial spondyloarthritis, or psoriatic arthritis with axial skeletal involvement). Clinical indication for [18F]fluoride PET examination. Clinical indication for initiation of drug therapy (TNF blocker, interleuking-17 blocker, Janus kinase inhibitor, NSAID.) for a period of at least one month.

Exclusion criteria

Exclusion criteria: -Pregnancy -Severe renal insufficiency -Cardiac pacemaker -Non-MR compatible foreign material -Severe claustrophobia -Known allergy to contrast media -Inability to understand the patient information sheet

Design outcomes

Primary

MeasureTime frame
To investigate the anti-inflammatory and anti-osteoblastic effects of various drug therapies (TNF blocker, interleukin-17 blocker Janus kinase inhibitor, NSAID) in patients with active spondyloarthritis during the course. To investigate the correlation of clinical disease activity with the extent and course of inflammatory changes (MRI) or increased metabolic ([18F]fluoride PET) activity.

Secondary

MeasureTime frame
Comparison of the examination results of native MRI examinations in the regions of the ankle, spine and sacroiliac joints of spondyloarthritis patients before and after drug therapy, among others, with the examination results obtained by means of [18F]fluoride PET/MRI. In detail, the skeletal sites showing inflammatory activity in MRI are compared to the exact anatomical regions showing metabolic activity in [18F]fluoride PET/MRI.

Countries

Germany

Contacts

Public ContactStyliani Tsiami

Rheumazentrum Ruhrgebiet

styliani.tsiami@elisabethgruppe.de02325-592-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026