Recruiting

Observational Study

Sponsor:

Gilles Boire

Code:

NCT00512239

Conditions

Rheumatoid Arthritis

Inflammatory Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Rheumatoid Arthritis

Inflammatory Arthritis

Study ID

NCT00512239

Start date

Jul, 1998

Status verified date

Mar, 2025

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Early Rheumatoid arthritis
  • Early Inflammatory Arthritis

Exclusion Criteria:

  • Refusal or inability to consent
  • Infectious arthritis
  • Microcrystalline arthritis

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

EUPA cohort

Consecutive adult patients presenting to receive rheumatological care at the Sherbrooke University Hospital Centre (CHUS) with an immune-mediated inflammatory arthritis affecting at least 3 joints for a duration of more than 4 and less than 52 weeks.

Primary outcome measure

  • Role of anti-Sa antibodies as predictor of severe radiographical damage [ Time Frame: At 60 months after symptom onset ]

Central Contacts and Locations

Central contacts

Locations

Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 4N4

Contacts

More Information

Sponsor

Gilles Boire

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Keywords

  • Early Rheumatoid Arthritis
  • Early inflammatory arthritis
  • Biomarkers
  • Autoantibodies
  • Anti-Sa antibodies
  • Anti-CCP antibodies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gilles Boire on 2025-03-25.