To study patients with clinically suspect arthralgia in order to 1) develop diagnostic/prognostic markers (a. markers of systemic and b. local inflammation as well as c. autoantibodies) for the development of RA 2) to improve the mechanistic…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical arthritis detected at physical examination by the rheumatologist,
persisting arthritis (present at two subsequent visits) or initiation of
treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs).
Secondary outcome
na
Background summary
At present, we cannot accurately identify patients with rheumatoid arthritis
(RA) in the phase prior to clinically apparent arthritis. Measuring the three
core processes of rheumatoid arthritis (auto-antibodies, local inflammation and
systemic inflammation) serve well to identify RA patients in phases with
clinical arthritis, yet are insufficient in pre-arthritis phases. An improved
mechanistic understanding of these three processes will yield better biomarkers
to characterize RA before arthritis has become persistent. Furthermore, our
comprehension of the mechanisms underlying progression from arthralgia to
arthritis is limited as well as our understanding of patients* well-being in
this phase.
Study objective
To study patients with clinically suspect arthralgia in order to 1) develop
diagnostic/prognostic markers (a. markers of systemic and b. local inflammation
as well as c. autoantibodies) for the development of RA 2) to improve the
mechanistic understanding for progression from clinically suspect arthralgia
(CSA) to RA and 3) to determine the physical and psychological well-being of
patients with CSA during their disease course.
Study design
Observational cohort study.
Study burden and risks
In total, 4 visits will be scheduled in 24 months, or fewer in case patients
develop arthritis or in case complaints spontaneously resolve. Visits as well
as the collection of data will be integrated in regular patient care. Almost
all data that will be collected in this study will come from measurements
performed in regular patient care anyway (medical history taking, physical
examination, radiographs of hands and feet, blood sampling). The only
additional measurements are questionnaires, ultrasound of hands and feet, and
additional blood samples (±80 ml).
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Arthralgia on hand, wrist or feet joints that is according to the rheumatologist clinical suspect to become RA (e.g. because of an inflammatory type or the presence of morning stiffness)
- Recent onset of complaints (< 1 year)
- Age > 18 years
- Written informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study as this precludes the presence of CSA:
- Presence of, or history of, clinically apparent arthritis
- Previous or current treatment with DMARDs or corticosteroids
- If another condition or explanation for the pain is more likely (other than imminent RA), a patient does not have CSA
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 | NL59939.078.16 |