Objective main studyObjectives to develop diagnostic and imaging tools to identify early RA-patients and stratify established RA-patients for individualized treatment strategies.Objective ultrasound study (amendment)-To compare inflammatory…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters main study
- Presence of features of arthritis on MRI, correlated to clinical parameters
- Predictive value of MRI for development of RA
Primary study parameters ultrasound study (amendment)
- Presence of US inflammatory features correlated to MR detected (teno)
synovitis and clinical parameters.
Secondary outcome
Secundary parameters main study
- MRI findings in patients without RA but with an alternative diagnosis (e.g.
undifferentiated arthritis, psoriatic arthritis)
Background summary
Rheumatoid arthritis (RA) is a disorder leading to disability and serious loss
of quality of life. Evidence is accumulating that postponing the onset and, in
established RA, induction of drug free remission may be achieved if effective
treatments are started in a timely manner in the individual patient. Hence, the
ability to diagnose arthritis at an early stage and to apply the right
medication at the right time in established RA is key to (cost) effective
treatment of RA.
Study objective
Objective main study
Objectives to develop diagnostic and imaging tools to identify early
RA-patients and stratify established RA-patients for individualized treatment
strategies.
Objective ultrasound study (amendment)
-To compare inflammatory ultrasound findings to MR-detected (teno)synovitis of
the hand and foot in patients with (early) RA.
-To identify (teno) synovitis in the hand and foot with US, to differentiate
active from chronic tenosynovitis and to compare this to the MRI findings.
Study design
Study design main study
This is a longitudinal observational study. Patients referred to the LUMC early
arthritis clinic that fulfill the inclusion criteria will have 1.5 Tesla (T)
MRI of the (most painful or dominant) hand and foot at baseline. A patient
friendly extremity scanner will be used. Those early arthritis patients with
undifferentiated or rheumatoid arthritis will have repeated MR at 4, 8, 12 and
24 months. The 1.5T MRI will be performed using state of the art techniques,
with intravenous contrast administration. Inclusion of patients will continue
initially until a total sample size at baseline of 100 patients is reached.
Follow up studies will be performed in two to three years. Results will be
correlated with the final diagnosis and with clinical parameters obtained
during routine patient care.
Study design ultrasound study (amendment)
All (early) RA patients who agreed to perform MRI of the hand and foot
(baseline and follow-up) will be asked to undergo ultrasound of the hand and
foot as well. The researcher performing US will be blinded to the MRI findings.
A US protocol will be used to be able to compare to the RAMRIS score and
established US7joint score. Grey scale and power doppler US will be performed.
The presence or absence of synovitis will be determined in the four
compartments of the wrist, the 5 MCP joints and PIP 2 and 3 joints (hand) and 5
MTP joints (foot)). Tenosynovitis will be determined in the flexor and extensor
compartments of the wrist and flexor and extensor tendons at the level of the
MCP joints (hand), and the flexor and extensor tendons of the MTP points
(foot). With the use of color/power Doppler (PD US) the presence or absence of
hypervascularisation will be evaluated. Examination time is approximately 15
minutes.
Inclusion initially will be 100 patients.
Study burden and risks
Risks main study
- Limited risk of contrast reactions or allergy (<1%).
Risks ultrasound study (amendment)
- None
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Patients referred with non-traumatic arthritis of at least one joint as confirmed by a medical doctor
- Duration of symptoms less than two years
Exclusion criteria
- Confirmed septic arthritis or crystal arthropathy
- Routine MRI-contraindications
- Pregnancy
- Renal insufficiency
- Gadolinium contrast allergy
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL32390.058.10 |