NCT04530682

Brief Summary

Accurate knowledge of the humoral immune responses induced by SARS-CoV-2 in patients undergoing immunosuppressive therapy is essential to guide recommendations for infected patients and for vaccination policy for uninfected immunosuppressed patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

July 27, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

July 27, 2020

Last Update Submit

April 29, 2024

Conditions

Chronic Inflammatory Rheumatism

Keywords

COVID-19SARS-CoV2Rheumatoid arthritisSpondyloarthritisSeroprevalenceSeropersistence

Outcome Measures

Primary Outcomes (2)

  • Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms

    Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline in patients with chronic inflammatory rheumatisms

    at baseline

  • Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms

    Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at 6 months in patients with chronic inflammatory rheumatisms

    at 6 months after inclusion

Secondary Outcomes (6)

  • To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls.

    at 12 months after inclusion

  • To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls

    at 24 months after inclusion

  • Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms

    baseline

  • Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms

    at 6 month after inclusion

  • Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms

    at 12 month after inclusion

  • +1 more secondary outcomes

Study Arms (2)

SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs)

200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort.

Biological: Biological samples

Control group

100 health professionals participating in the COVID-BIOTOUL cohort will be selected to be matched on age, gender, and the time between the date of infection with Covid-19 and the first serology of CIR patients.

Interventions

Biological samplesBIOLOGICAL

Serum and plasma samples. At baseline, 6, 12 and 24 months

SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs)

Eligibility Criteria

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

200 participants with chronic inflammatory rheumatisms and positive status in the serology for SARS-CoV-2. This population will be compared with a healthy control group from the cohort Covid-Biotoul

You may qualify if:

  • Patients with rheumatoid arthritis or spondyloarthritis
  • Under biotherapy, or conventional synthetic Disease-modifying antirheumatic drugs (csDMARD) or Nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids for at least one month during the year 2020
  • Agreeement to participate two years in the study

You may not qualify if:

  • Pregnant or breastfeeding woman
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hopsitalier universitaire de Montpellier

Montpellier, Occitanie, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples at baseline. Serum samples at 0, 6, 12 and 24 months.

MeSH Terms

Conditions

COVID-19Arthritis, RheumatoidSpondylarthritis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone Diseases

Study Design

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

Study Record Dates

First Submitted

July 27, 2020

First Posted

August 28, 2020

Study Start

March 5, 2021

Primary Completion

June 23, 2022

Study Completion

February 15, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations

FR(1)