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
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|Condition or disease||Intervention/treatment|
|Chikungunya||Other: 15 years Follow-up group|
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 Type :||Observational|
|Estimated Enrollment :||220 participants|
|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|
- 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.
- 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.
- 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.
- 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.
- 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
- 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
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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|
- 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)
- Impossible informed consent (cognitive impairment,…).
- Lost-to-follow-up patients, refusal to participate. -Pre-existing chronic inflammatory rheumatic disease (prior to CHIKV infection)-
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
|Contact: Xavier GUILLOT||0262 90 59 email@example.com|
|CHU La Réunion (Nord)||Recruiting|
|Saint-Denis, Réunion, 97400|
|Contact: Xavier GUILLOT firstname.lastname@example.org|
|Principal Investigator: Xavier GUILLOT|
|CH Ouest Réunion||Not yet recruiting|
|Contact: Julia GOOSSENS Ju.GOOSSENS@chor.re|
|Principal Investigator: Julia GOOSSENS|
|CHU La Réunion (Sud)||Recruiting|
|Saint-Pierre, Réunion, 97448|
|Contact: Judith PAYET, MD|
|Responsible Party:||Centre Hospitalier Universitaire de la Réunion|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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