NCT04832022

Brief Summary

To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

13 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 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

March 31, 2021

Last Update Submit

August 11, 2023

Conditions

Rheumatic DiseasesSARS-CoV InfectionCOVID-19

Outcome Measures

Primary Outcomes (2)

  • Proportion of documented COVID-19 infection in vaccinated chronic inflammatory Rheumatism patients

    Proportion of documented COVID-19 infection according to Food and Drug Administration criteria in vaccinated chronic inflammatory Rheumatism patients

    At 3 months of the 1st dose of vaccine SARS-COV-2

  • Proportion of documented COVID-19 infection in non vaccinated chronic inflammatory Rheumatism patients

    Proportion of documented COVID-19 infection according to Food and Drug Administration criteria in non vaccinated chronic inflammatory Rheumatism patients

    At 3 months of the 1st dose of vaccine SARS-COV-2

Secondary Outcomes (29)

  • Proportion of documented COVID-19 infection

    6 months from 1st vaccine dose

  • Proportion of documented COVID-19 infection

    12 months from 1st vaccine dose

  • occurrence of infections by type of treatment

    6 months from 1st vaccine dose

  • occurrence of infections by type of treatment

    12 months from 1st vaccine dose

  • occurrence of infections by type of vaccine

    3 months from 1st vaccine dose

  • +24 more secondary outcomes

Study Arms (2)

Vaccinated

Seronegative Chronic Inflammatory Rheumatism (CIR) who accepted vaccination against SARS-CoV2

Other: Biological samples

Non vaccinated

Seronegative Chronic Inflammatory Rheumatism (CIR) who refused vaccination against SARS-CoV2

Other: Biological samples

Interventions

Biological samplesOTHER

Serum and plasma samples. At baseline, 3, 6 and 12 months

Non vaccinatedVaccinated

Eligibility Criteria

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

1500 CIR patients with or without SARS-COV2 vaccine.

You may qualify if:

  • Adult ≥ 18 years old,
  • Chronic inflammatory arthritis: rheumatoid arthritis, psoriatic arthritis, axial SpA, diagnosed by a rheumatologist
  • Under csDMARD (conventional synthetic Disease-modifying antirheumatic drug), biotherapy, JAK inhibitor or under symptomatic treatment such as NSAIDs or corticosteroids alone or in combination with a DMARD (Disease-modifying antirheumatic drug)
  • Subject having signed a consent
  • Affiliated with Social Security
  • Having accepted or agreed to be vaccinated against COVID-19 (for vaccine group)
  • Having refused to be vaccinated against COVID-19 (for non-vaccine group)

You may not qualify if:

  • Adult patient under legal protection (guardian, curator)
  • Patient vaccinated with an anti-SARS-CoV-2 vaccine before the serological test
  • Refusal to be vaccinated (for vaccine group)
  • Acceptance to be vaccinated (for non-vaccine group))
  • Refusal to participate in the study
  • Pregnancy and breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Centre hospitalier universitaire de Montpellier

Montpellier, Occitanie, 34295, France

Location

CHU Brest

Brest, 29200, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU Marseille

Marseille, 13274, France

Location

CHU Nancy

Nancy, 54511, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Nice

Nice, 06001, France

Location

CHU Nîmes

Nîmes, 30029, France

Location

APHP Saint Antoine

Paris, 75012, France

Location

APHP La pitié Salpêtrière

Paris, 75013, France

Location

CHU Rouen

Rouen, 76000, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

CHU Tours

Tours, 37170, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples. At visit baseline, 3, 6, 12 months.

MeSH Terms

Conditions

Rheumatic DiseasesSevere Acute Respiratory SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesRespiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Design

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

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

April 7, 2021

Primary Completion

June 21, 2022

Study Completion

June 27, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

FR(13)