NCT04838574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

March 19, 2021

Last Update Submit

March 3, 2026

Conditions

Chikungunya

Outcome Measures

Primary Outcomes (1)

  • Describe the phenotype of chronic post-Chikungunya rheumatological pictures persisting 15 years after the initial infection

    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.

    Day 0

Secondary Outcomes (4)

  • To describe the phenotype of post-Chikungunya chronic rheumatological pictures that have resolved 15 years after the initial infection.

    Day 0

  • To specify the time of onset in relation to the initial infection of rheumatological pictures initially attributed to Chikungunya.

    Day 0

  • Timing of onset of rheumatologic symptomatology in relation to CHIKV infection

    Day 0

  • Rheumatological pictures pre-existing the infection

    Day 0

Interventions

15 years Follow-up groupOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients previously included in the RHUMATOCHIK study, or diagnosed as Chikungunya-related Rheumatoid Arthritis in the Reunion Island.

You may qualify if:

  • 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)

You may not qualify if:

  • Impossible informed consent (cognitive impairment,…).
  • Lost-to-follow-up patients, refusal to participate. -Pre-existing chronic inflammatory rheumatic disease (prior to CHIKV infection)-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU La Réunion (Nord)

Saint-Denis, 97400, Reunion

Location

CH Ouest Réunion

Saint-Paul, Reunion

Location

CHU La Réunion (Sud)

Saint-Pierre, 97448, Reunion

Location

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus InfectionsArbovirus InfectionsVector Borne DiseasesInfectionsMosquito-Borne DiseasesVirus DiseasesTogaviridae InfectionsRNA Virus Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

April 9, 2021

Study Start

February 20, 2023

Primary Completion

January 26, 2026

Study Completion

January 26, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

RE(3)