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Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years (ChikRhuma15)

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ClinicalTrials.gov Identifier: NCT04838574
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 13, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Study Description
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Brief Summary:
Reunion Island was struck by a severe Chikungunya outbreak in 2005-2006. Three hundred and seven Chikungunya patients were evaluated by 4 rheumatologists 2 months after the initial infection (RHUMATOCHIK study). Eighty-three percents still reported joint pain and 43% joint swelling in telephone interviews after 32 months (Bouquillard et al., 2018). The primary objective of the present study is to assess and classify precisely persistent Chi-related joint diseases after 15 years, in a second rheumatology examination.

Condition or disease Intervention/treatment
Chikungunya Other: 15 years Follow-up group

Detailed Description:

Reunion Island was struck in 2005-2006 by the most severe Chikungunya outbreak (seroprevalence 38% (Gérardin et al., 2013)) in a developed but previously non-immunized country, providing an unique opportunity for studying Chikungunya-related joint symptoms and their long-term evolution. In a previous study, the investigators demonstrated that at least 17/73 patients initially classified as Chikungunya-related inflammatory joint diseases after 40 months still suffered from inflammatory joint symptoms fullfilling validated classification criteria after 13 years (Guillot et al., 2020). However, in this monocentric study, the investigators did not consider the full spectrum of Chikungunya-related rheumatic diseases, the population was not fully representative and the sample size was not sufficient to perform statistical analyses nor identify poor prognosis markers. In the RHUMATOCHIK cohort study, 307 patients were evaluated by 4 rheumatologists 2 months after the infection, 83% and 43% reported persistent joint pain and joint swelling respectively after 32 months in potentially biased telephone interviews (Bouquillard et al., 2018).

In this context, the present study aims at performing a systematic clinical rheumatologic re-evaluation of the RHUMATOCHIK patients after 15 years, in order to precisely describe and classify the full spectrum of persistent Chikungunya-related joint diseases in a larger population.

After a telephone interview and screening questionnaire, these patients will be clinically re-evaluated by a second rheumatologist in a multicenter transversal follow-up study.

Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years
Actual Study Start Date : February 20, 2023
Estimated Primary Completion Date : February 19, 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Groups and Cohorts
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Intervention Details:
  • Other: 15 years Follow-up group
    Phone recruitment, screening interview and eligibility questionnaire. Patient inclusion during rheumatologic evaluation : questionnaire, examination and data collection in one of the 4 study hospital centers.

Outcome Measures
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Primary Outcome Measures :
  1. Describe the phenotype of chronic post-Chikungunya rheumatological pictures persisting 15 years after the initial infection [ Time Frame: Day 0 ]
    The primary outcome is the distribution (%) of rheumatic disease types among the patients with persistent Chikungunya-related rheumatic symptoms after 15 years ie. the percentage of patients fullfilling validated classification criteria of inflammatory rheumatic diseases (Rheumatoid Arthritis (Aletaha et al., 2010), Spondyloarthritis (Dougados et al., 1991; Rudwaleit et al., 2011a), Psoriatic Arthritis (Taylor et al., 2006), RS3PE - or undifferentiated arthritis), or classified in other rheumatic diseases (osteoarthritis, tendinitis, capsulitis, carpal tunnel syndrome, radicular pain, crystal-induced arthritis (Neogi et al., 2015), fibromyalgia (Wolfe et al., 2011)) - at inclusion.


Secondary Outcome Measures :
  1. To describe the phenotype of post-Chikungunya chronic rheumatological pictures that have resolved 15 years after the initial infection. [ Time Frame: Day 0 ]
    The distribution (%) of rheumatic disease types among the patients with no more Chikungunya-related rheumatic symptoms after 15 years.

  2. To specify the time of onset in relation to the initial infection of rheumatological pictures initially attributed to Chikungunya. [ Time Frame: Day 0 ]
    The mean duration (months) of Chikungunya-related rheumatic diseases.

  3. Timing of onset of rheumatologic symptomatology in relation to CHIKV infection [ Time Frame: Day 0 ]
    Date of infection, date of onset of rheumatologic symptoms, time between the two (months), average duration (months) of rheumatologic symptomatology attributed to CHIKV infection

  4. Rheumatological pictures pre-existing the infection [ Time Frame: Day 0 ]
    Comparison of patients with persistent versus resolving Chikungunya-related rheumatic diseases after 15 years, in order to identify prognostic factors


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients previously included in the RHUMATOCHIK study, or diagnosed as Chikungunya-related Rheumatoid Arthritis in the Reunion Island.
Criteria

Inclusion Criteria:

  • Patients previously included in the RHUMATOCHIK study (N=307), or diagnosed as Chikungunya-related Rheumatoid Arthritis (N=21) after telephonic screening and given their oral consent
  • Chikungunya infection (positive serology and/or evocative symptoms in the epidemic context)

Exclusion Criteria:

  • Impossible informed consent (cognitive impairment,…).
  • Lost-to-follow-up patients, refusal to participate. -Pre-existing chronic inflammatory rheumatic disease (prior to CHIKV infection)-
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838574


Contacts
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Contact: Xavier GUILLOT 0262 90 59 20 xavier.guillot@chu-reunion.fr

Locations
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Réunion
CHU La Réunion (Nord) Recruiting
Saint-Denis, Réunion, 97400
Contact: Xavier GUILLOT       xavier.guillot@chu-reunion.fr   
Principal Investigator: Xavier GUILLOT         
CH Ouest Réunion Not yet recruiting
Saint-Paul, Réunion
Contact: Julia GOOSSENS       Ju.GOOSSENS@chor.re   
Principal Investigator: Julia GOOSSENS         
CHU La Réunion (Sud) Recruiting
Saint-Pierre, Réunion, 97448
Contact: Judith PAYET, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
More Information
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT04838574    
Other Study ID Numbers: 2021/CHU/03
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 13, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chikungunya Fever
Rheumatic Diseases
Alphavirus Infections
Arbovirus Infections
Vector Borne Diseases
Infections
 Virus Diseases
Togaviridae Infections
RNA Virus Infections
Musculoskeletal Diseases
Connective Tissue Diseases