Prognostic Evaluation of Inflammatory Polyarthritis of Recent Onset

NCT00512239 | Recruiting DMC

• 2 other identifiers: EUPA97-04CIHR MOP-110959
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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)

  At 60 months after symptom onset

Secondary Outcomes (3)

• Role of anti-Sa antibodies as predictor of the use of advanced therapy

  At baseline and annually over 60 months after symptom onst

• Role of anti-Sa antibodies as predictor of persistent disease activity

  At inclusion and annually over 60 months after symptom onset

• Role of psychosocial determinants as predictors of severe outcomes

  At baseline and annually over 60 months after symptom onset

Other Outcomes (3)

• Epigenetic predictors of severe outcomes

  At baseline and annually over 60 months from symptom onset

• Epigenetic predictors of persistent disease activity

  At baseline and annually over 60 months after symptom onset

• Genetic predictors of severe outcomes

  At baseline and annually over 60 months after symptom onset

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Early Rheumatoid arthritis
• Early Inflammatory Arthritis

You may not qualify if:

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

Sponsors & Collaborators

• Gilles Boire: lead
• The Arthritis Society, Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 4N4, Canada

RECRUITING

Related Publications (10)

• Maksymowych WP, Boire G, van Schaardenburg D, Wichuk S, Turk S, Boers M, Siminovitch KA, Bykerk V, Keystone E, Tak PP, van Kuijk AW, Landewe R, van der Heijde D, Murphy M, Marotta A. 14-3-3eta Autoantibodies: Diagnostic Use in Early Rheumatoid Arthritis. J Rheumatol. 2015 Sep;42(9):1587-94. doi: 10.3899/jrheum.141385. Epub 2015 Jul 15.

  PMID: 26178283 BACKGROUND

• Leblanc-Trudeau C, Dobkin PL, Carrier N, Cossette P, de Brum-Fernandes AJ, Liang P, Masetto A, Boire G. Depressive symptoms predict future simple disease activity index scores and simple disease activity index remission in a prospective cohort of patients with early inflammatory polyarthritis. Rheumatology (Oxford). 2015 Dec;54(12):2205-14. doi: 10.1093/rheumatology/kev272. Epub 2015 Jul 25.

  PMID: 26209789 BACKGROUND

• Challener GJ, Jones JD, Pelzek AJ, Hamilton BJ, Boire G, de Brum-Fernandes AJ, Masetto A, Carrier N, Menard HA, Silverman GJ, Rigby WFC. Anti-carbamylated Protein Antibody Levels Correlate with Anti-Sa (Citrullinated Vimentin) Antibody Levels in Rheumatoid Arthritis. J Rheumatol. 2016 Feb;43(2):273-281. doi: 10.3899/jrheum.150179. Epub 2015 Dec 15.

  PMID: 26669911 BACKGROUND

• Carrier N, Marotta A, de Brum-Fernandes AJ, Liang P, Masetto A, Menard HA, Maksymowych WP, Boire G. Serum levels of 14-3-3eta protein supplement C-reactive protein and rheumatoid arthritis-associated antibodies to predict clinical and radiographic outcomes in a prospective cohort of patients with recent-onset inflammatory polyarthritis. Arthritis Res Ther. 2016 Feb 1;18:37. doi: 10.1186/s13075-016-0935-z.

  PMID: 26832367 BACKGROUND

• Boire G, Cossette P, de Brum-Fernandes AJ, Liang P, Niyonsenga T, Zhou ZJ, Carrier N, Daniel C, Menard HA. Anti-Sa antibodies and antibodies against cyclic citrullinated peptide are not equivalent as predictors of severe outcomes in patients with recent-onset polyarthritis. Arthritis Res Ther. 2005;7(3):R592-603. doi: 10.1186/ar1719. Epub 2005 Mar 17.

  PMID: 15899046 RESULT

• Guzian MC, Carrier N, Cossette P, de Brum-Fernandes AJ, Liang P, Menard HA, Boire G. Outcomes in recent-onset inflammatory polyarthritis differ according to initial titers, persistence over time, and specificity of the autoantibodies. Arthritis Care Res (Hoboken). 2010 Nov;62(11):1624-32. doi: 10.1002/acr.20288. Epub 2010 Jul 8.

  PMID: 20617532 RESULT

• Carrier N, Cossette P, Daniel C, de Brum-Fernandes A, Liang P, Menard HA, Boire G. The DERAA HLA-DR alleles in patients with early polyarthritis: protection against severe disease and lack of association with rheumatoid arthritis autoantibodies. Arthritis Rheum. 2009 Mar;60(3):698-707. doi: 10.1002/art.24353.

  PMID: 19248090 RESULT

• Dobkin PL, Liu A, Abrahamowicz M, Carrier N, de Brum-Fernandes AJ, Cossette P, Boire G. Predictors of pain for patients with early inflammatory polyarthritis. Arthritis Care Res (Hoboken). 2013 Jun;65(6):992-9. doi: 10.1002/acr.21923.

  PMID: 23281243 RESULT

• Maksymowych WP, van der Heijde D, Allaart CF, Landewe R, Boire G, Tak PP, Gui Y, Ghahary A, Kilani R, Marotta A. 14-3-3eta is a novel mediator associated with the pathogenesis of rheumatoid arthritis and joint damage. Arthritis Res Ther. 2014 Apr 21;16(2):R99. doi: 10.1186/ar4547.

  PMID: 24751211 RESULT

• Jones JD, Hamilton BJ, Challener GJ, de Brum-Fernandes AJ, Cossette P, Liang P, Masetto A, Menard HA, Carrier N, Boyle DL, Rosengren S, Boire G, Rigby WF. Serum C-X-C motif chemokine 13 is elevated in early and established rheumatoid arthritis and correlates with rheumatoid factor levels. Arthritis Res Ther. 2014 Apr 25;16(2):R103. doi: 10.1186/ar4552.

  PMID: 24766912 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum, genomic DNA and RNA from peripheral blood, peripheral blood mononuclear cells (PBMCs) used for in vitro osteoclastogenesis

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gilles Boire, MD, MSc

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles Boire, MD, MSc

CONTACT

(819) 564-5261; Gilles.Boire@USherbrooke.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 7, 2007
• Study Start: July 1, 1998
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)