Virtual Management of Rheumatoid Arthritis | NCT05124782

Studies
Virtual Management of Rheumatoid Arthritis

NCT05124782

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Sep 15, 2025Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Rheumatoid Arthritis Impact of Disease questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2021Actual

Primary Completion Date

Nov 22, 2023Actual

Completion Date

Nov 22, 2023Actual

First Submitted Date

Oct 22, 2021

First Submission Date that Met QC Criteria

Nov 15, 2021

First Posted Date

Nov 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2025

Last Update Posted Date

Sep 15, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to optimize the care of patients with RA seen in virtual consultation.

Detailed Description

This study will be organized in two consecutive steps:

A first descriptive step that will consist of a retrospective analysis of virtual consultation records of patients with RA during the pandemic and lockdown period in order to analyze on which criteria the patients were assessed and followed during this period.
The second step will consist in evaluating the interest of the systematic use in virtual consultation of a patient reported outcome (PRO), the RAID (Rheumatoid Arthritis Impact of Disease) questionnaire; and analyze how its results influence the rheumatologist decision-making.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with rheumatoid arthritis		Patients seen in virtual consultation	Other: Rheumatoid Arthritis Impact of Disease questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rheumatoid Arthritis Impact of Disease questionnaire	Other	Rheumatoid Arthritis Impact of Disease questionnaire	Patients with rheumatoid arthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of face to face consultation, hospitalization and therapeutic modifications	The primary outcome will be the rate of face to face consultation, hospitalization and therapeutic modifications decided by the rheumatologist during the virtual consultation	Inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria
Follow-up in the rheumatology department of Cochin Hospital
Affiliated with a social security scheme
Non-opposition to participating in the study
Patients with a valid email address (registration to the virtual consultation system)

Exclusion Criteria:

Opposition to participate to this research
Inability to understand or speak French
Patient under tutor or curator ship
patients under medical state help

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with rheumatoid arthritis followed in a tertiary center (University Hospital Cochin)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jérôme AVOUAC, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rheumatology Department, Cochin Hospital		Paris	IDF	75014	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided