Clinical trial NCT04838574: Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years
Official title: Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chikungunya
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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)-

Primary outcomes:
measure: Describe the phenotype of chronic post-Chikungunya rheumatological pictures persisting 15 years after the initial infection
timeFrame: Day 0
Secondary outcomes:
measure: To describe the phenotype of post-Chikungunya chronic rheumatological pictures that have resolved 15 years after the initial infection.
timeFrame: Day 0
measure: To specify the time of onset in relation to the initial infection of rheumatological pictures initially attributed to Chikungunya.
timeFrame: Day 0
measure: Timing of onset of rheumatologic symptomatology in relation to CHIKV infection
timeFrame: Day 0
measure: Rheumatological pictures pre-existing the infection
timeFrame: Day 0
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU La Réunion (Nord)
city: Saint-Paul
country: Réunion
facility: CH Ouest Réunion
city: Saint-Pierre
country: Réunion
facility: CHU La Réunion (Sud)
Study officials:
References: