NCT04393233

Brief Summary

The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 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

April 22, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2020

Completed
Last Updated

August 9, 2024

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 22, 2020

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis

    Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD

    1 Day

Eligibility Criteria

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

Rheumatoid arthritis patients with ongoing DMARD therapy.

You may qualify if:

  • Rheumatoid arthritis satisfying ACR/EULAR criteria
  • Ongoing DMARD therapy

You may not qualify if:

  • Inhability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

April 22, 2020

First Posted

May 19, 2020

Study Start

April 23, 2020

Primary Completion

August 23, 2020

Study Completion

August 23, 2020

Last Updated

August 9, 2024

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning one month and ending five years following the end study
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations