To evaluate the presence of subclinical inflammation in painful joints in ACPA+ patients without clinical synovitis using MRI
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of synovitis, erosions, bone marrow edema or tenosynovitis on MRI.
Secondary outcome
na
Background summary
Anti-citrullinated protein antibodies (ACPA) are autoantibodies that are
frequently detected in the blood of rheumatoid arthritis patients. ACPA
positive RA patients have a worse prognosis than ACPA negative patients.
Several recent studies revealed that ACPA are present years before the onset of
clinically detectable synovitis and that the ACPA-response matures in the
preclinical phase. Our hypothesis is that ACPA-positive patients with joint
complaints but without clinically detectable synovitis will have subclinical
inflammation, which can be visualized by MRI.
Study objective
To evaluate the presence of subclinical inflammation in painful joints in ACPA+
patients without clinical synovitis using MRI
Study design
The study is a single center observational study. Patients will be scanned on
the 1.5T extremity MRI. Depending on symptoms one hand or feet will be scanned.
Radiographs of the hand and feet will be performed before MRI imaging as part
of standard clinical practice. Standard clinical MRI protocols for the affected
joint will be used. Image sequences used are T1 weighted, T2 weighted with fat
suppression and T1 weighted after gadolinium contrast injection with fat
suppression. MRI images will be evaluated for synovitis, tenosynovitis,
erosions, bone marrow edema and cartilage damage. MRI images will be evaluated
in consensus by two musculoskeletal radiologists of the LUMC who will be
blinded to the patients* names. Previously scanned images from ACPA+ RA
patients will be used for comparison.
Study burden and risks
Risk: Gadolinium contrast administration: low (<1%) risk of mild reactions to
administration.
P.O. Box 9600
2300 RC Leiden
NL
P.O. Box 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Joint pain > 6 weeks (without clinical active arthritis/enthesitis)
ACPA positive
Age > 18 years
Written informed consent
Exclusion criteria
An explanation for peripheral joint pain on plain film
Arthritis and/or enthesitis of the affected joint (physical examination within 1 week before MRI by rheumatologist)
Known painful condition, which could interfere with the evaluation of pain severity e.g. fibromyalgia
Routine MRI-contraindications (e.g. instable metal implants, pacemaker/ICD, vascular clips).
Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35400.058.11 |