NCT04933097

Brief Summary

Evaluation of a new screening method for sarcopenia in rheumatoid arthritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable rheumatoid-arthritis

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

2.8 years

First QC Date

June 11, 2021

Last Update Submit

May 17, 2024

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Quadricepsmeasurement

    The three measurements will be performed by two different operators and the results will be expressed in Newton/m.

    Day 0

Study Arms (1)

Sarcopenia

EXPERIMENTAL

Only one arm with the sarcopenia assessment.

Device: Microfet2®

Interventions

Microfet2®DEVICE

Conducting a day hospitalization including analyses: 1. Quantitative muscular analysis by measuring the DEXA of the whole body, the reference method for measuring body compartments and allowing the diagnosis of sarcopenia (IMMA\<7 in men and 5.5 in women) 2. Qualitative muscular analysis: * isokinetic measurement of muscular strength carried out on 3 muscle groups using a manual measurement sensor such as Microfet2 ® : quadriceps, triceps brachii, biceps * measurement of grip strength using Jamar® equipment validated as recommended by the EWGSOP * a walking test to assess the functional impact of sarcopenia and its severity

Sarcopenia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis defined according to ACR/EULAR 2010 criteria,
  • Follow-up at the University Hospital of Reims,
  • Signed consent

You may not qualify if:

  • Inability to perform a functional test (walking test)
  • Patient under legal protection
  • Patients not affiliated to the social security system
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, 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
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 21, 2021

Study Start

July 29, 2021

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

FR(1)