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CompletedNCT04393233RHUMACOVIDUpdated Aug 9, 2024

Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation

An observational study in Rheumatoid Arthritis and COVID, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Rheumatoid Arthritis
  • COVID
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In context

Arthritis, Rheumatoid

2,963 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 300 is above the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 600 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Rheumatoid arthritis patients with ongoing DMARD therapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inhability to consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No
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What researchers measure

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

    Time frame: 1 Day

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Study locations

1 site
  • CHRU de Brest
    Brest, 29609, France
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References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04393233
Responsible party
Sponsor
First posted
May 19, 2020
Start date
Apr 23, 2020
Primary completion
Aug 23, 2020
Completion
Aug 23, 2020
Last update
Aug 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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