Prognostic Evaluation of Inflammatory Polyarthritis of Recent Onset
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorGilles Boire
About this trial
Inflammatory joint diseases are major causes of invalidity and morbidity. Rheumatoid arthritis (RA), the most frequent of chronic arthritides, affects close to 1% of the Canadian population. Direct and indirect costs of RA represent close to 1% of the gross national product. Recent evidence suggest that initiation of early (e.g., during the first 3-12 months of disease) aggressive treatment decreases both mortality and long term invalidity in RA and other chronic arthritides. However, a significant proportion of patients with early polyarthritis (EPA) have a benign evolution, even if they fulfill criteria for RA. On the contrary, most patients whose arthritis persist for more than 12 months have a progressive and destructive disease. Currently available clinical, serological and genetic markers of severity in arthritic patients perform poorly in EPA patients to identify those patients whose arthritis is likely to persist and thus who deserve an aggressive treatment.
The Investigators propose a prospective and longitudinal study to define the contribution of detection of rheumatoid arthritis-specific autoantibodies (RASA), either alone or in combination with other markers of severity, in the prognostic evaluation of patients presenting with EPA. Availability of such an effective serological tool to establish prognosis in individual patients would improve therapeutic decisions in clinical practice. The same prognostic tools would represent very powerful instruments to subset patients into more homogeneous groups in clinical trials, increasing their power.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Early Rheumatoid arthritis
Early Inflammatory Arthritis
Disqualifiers
Refusal or inability to consent
Infectious arthritis
Microcrystalline arthritis
Trial population
Patients with recent-onset inflammatory polyarthritis with an immune cause (excluding infection, crystal-induced) and without characteristics diagnostic for connective tissue diseases or systemic vasculatidies
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: EUPA cohort
Trial outcomes
Primary outcomes
1
Role of anti-Sa antibodies as predictor of severe radiographical damage
Proportion of patients who have detectable damage (that is a score of least 5, the minimally detectable difference) on radiographs of hands, wrists and feet according to Sharp score modified by van der Heijde (0-448; higher scores indicative of more damage)
Time frame
At 60 months after symptom onsetSecondary outcomes
1
Role of anti-Sa antibodies as predictor of the use of advanced therapy
Proportion of patients who use advanced therapies (biologics and Jak inhibitors) at the time of the visit
Time frame
At baseline and annually over 60 months after symptom onst2
Role of anti-Sa antibodies as predictor of persistent disease activity
Proportion of patients who fail to reach remission in disease activity at the time of the visit according to Simple Disease Activity Index (SDAI; 0.1-96; a higher score means higher disease activity; a score below 3.3 indicates remission)
Time frame
At inclusion and annually over 60 months after symptom onset3
Role of psychosocial determinants as predictors of severe outcomes
Proportion of participants who fail to reach remission at the time of the visit according to Simple Disease Activity Index (SDAI)
Time frame
At baseline and annually over 60 months after symptom onsetOther outcomes
1
Epigenetic predictors of severe outcomes
Proportion of patients who have detectable damage (that is a score of least 5, the minimally detectable difference) on radiographs of hands, wrists and feet according to Sharp score modified by van der Heijde (0-448; higher scores indicative of more damage)
Time frame
At baseline and annually over 60 months from symptom onset2
Epigenetic predictors of persistent disease activity
Proportion of participants who fail to reach remission at the time of the visit according to Simple Disease Activity Index (SDAI)
Time frame
At baseline and annually over 60 months after symptom onset3
Genetic predictors of severe outcomes
Proportion of patients who have detectable damage (that is a score of at least 5, the minimally detectable difference) on radiographs of hands, wrists and feet according to Sharp score modified by van der Heijde (0-448; higher scores indicative of more damage)
Time frame
At baseline and annually over 60 months after symptom onsetSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gilles Boire
Lead sponsor
Université de Sherbrooke
Sponsor institution
The Arthritis Society, Canada
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov