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History of Changes for Study: NCT04838574
Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years (ChikRhuma15)
Latest version (submitted April 6, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 6, 2021 None (earliest Version on record)
Comparison Format:

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Study NCT04838574
Submitted Date:  April 6, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2021/CHU/03
Brief Title: Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years (ChikRhuma15)
Official Title: Post-Chikungunya Rheumatism - Rheumatology Follow-up of Patients After 15 Years
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Not yet recruiting
Study Start: June 2021
Primary Completion: June 2024 [Anticipated]
Study Completion: June 2024 [Anticipated]
First Submitted: March 19, 2021
First Submitted that
Met QC Criteria:
April 6, 2021
First Posted: April 9, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 6, 2021
Last Update Posted: April 9, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Centre Hospitalier Universitaire de la Réunion
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Chikungunya
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 220 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: Adult patients previously included in the RHUMATOCHIK study, or diagnosed as Chikungunya-related Rheumatoid Arthritis in the Reunion Island.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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)-
Open or close this module Contacts/Locations
Central Contact Person: Xavier GUILLOT
Telephone: 0262 90 59 20
Email: xavier.guillot@chu-reunion.fr
Locations: Réunion
GH Est Réunion
Saint-Benoît, Réunion
Contact:Contact: Elsa DENOIX elsa.denoix@chu-reunion.fr
Contact:Principal Investigator: Elsa DENOIX
CHU La Réunion
Saint-Denis, Réunion, 97400
Contact:Contact: Xavier GUILLOT xavier.guillot@chu-reunion.fr
Contact:Principal Investigator: Xavier GUILLOT
Contact:Sub-Investigator: Judith PAYET
CH Ouest Réunion
Saint-Paul, Réunion
Contact:Contact: Julia GOOSSENS Ju.GOOSSENS@chor.re
Contact:Principal Investigator: Julia GOOSSENS
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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