Evaluation of the value of PET/MRI for diagnosis and treatment monitoring of patients with ankylosing Spondylitis before and after Treatment with a TNF-blocker

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016917

Enrollment

Registered

2019-08-19

Start date

2018-07-12

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

M45.09

Interventions

Group 1: Patients are candidates for tan therapy with a TNFa blocker, which means that they must have a high level of disease activity (BASDAI 4/10) despite treatment with at least 2 nonsteroidal anti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of ankylosing spondylitis Clinical indication for the onset of TNFa blocker therapy (BASDAI score of 4 despite prior treatment with at least 2 NSAIDs) over a period of at least one month Adult patients with ankylosing spondylitis who are to receive 18F PET examination according to clinical indication Written consent of the patient

Exclusion criteria

Exclusion criteria: Contraindication to an MRI examination (strong Claustrophobia, Non-removable, ferromagnetic foreign bodies, Pacemakers / ICD)· Contraindication to MRI contrast agents (High-grade renal insufficiency (GFR x 30 mg/dl; serum creatinine > 1.75 mg/dl)) Mental illness that limits understanding of the study protocol

Design outcomes

Primary

Measure	Time frame
Primary endpoint: 1.Investigation of the anti-inflammatory but also anti-osteoblastic effect of TNFa blockers over 3 months in patients with active ankylosing spondylitis, in whom the indication for therapy with a TNFa blocker based on clinically applicable criteria. 2.Investigation of the correlation of clinical disease activity with the extent and course of inflammatory changes (MRI) or increased metabolic (18F-PET) activity	—

Measure

Time frame

Primary endpoint: 1.Investigation of the anti-inflammatory but also anti-osteoblastic effect of TNFa blockers over 3 months in patients with active ankylosing spondylitis, in whom the indication for therapy with a TNFa blocker based on clinically applicable criteria. 2.Investigation of the correlation of clinical disease activity with the extent and course of inflammatory changes (MRI) or increased metabolic (18F-PET) activity

—

Secondary

Measure	Time frame
Secondary endpoint 1.Comparison of the results of native MRI examinations in spine and sacroiliacal joints of patients with ankylosing spondylitis before and after 3 months of TNFa-blocker therapy with the results and findings obtained with 18F-PET/MRI. The exact locations of the axis skeleton showing inflammatory activity in MRI are to be compared in detail with exactly the anatomical regions that have metabolic activity in 18F-PET/MRI.	—

Measure

Time frame

Secondary endpoint 1.Comparison of the results of native MRI examinations in spine and sacroiliacal joints of patients with ankylosing spondylitis before and after 3 months of TNFa-blocker therapy with the results and findings obtained with 18F-PET/MRI. The exact locations of the axis skeleton showing inflammatory activity in MRI are to be compared in detail with exactly the anatomical regions that have metabolic activity in 18F-PET/MRI.

—

Countries

Germany

Contacts

Public ContactXenofon Baraliakos

Rheumazentrum Ruhrgebiet

xenofon.baraliakos@elisabethgruppe.de02325592709

Outcome results

None listed

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