NCT02894047

Brief Summary

Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in adults. The erosive damage influences the functional prognosis in patients with RA. At present, there are no sufficiently sensitive and specific predictive markers of erosive damage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

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

Study Start

First participant enrolled

July 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

September 5, 2016

Last Update Submit

September 5, 2016

Conditions

Arthritis, Rheumatoid

Keywords

calcium-sensitive receptor

Outcome Measures

Primary Outcomes (1)

  • CaSR expression rate level on synovial monocytes

    measured by flow cytometry

    1 year

Interventions

bloodBIOLOGICAL

measurement of CaSR expression levels on synovial fluid monocytes

Eligibility Criteria

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

\- Patients consulting in the Department of Rheumatology at Amiens University Hospital

You may qualify if:

  • Patients consulting in the Department of Rheumatology at Amiens University Hospital
  • Age ≥ 18
  • RA meeting the 2010 ACR/EULAR criteria
  • Less than 2 years of RA progression
  • Effusion in at least 1 joint

You may not qualify if:

  • Inability to give informed consent
  • Ongoing pregnancy
  • Previous treatment with an anti-osteoporosis medication
  • Intra-articular corticoid or hyaluronic acid injection in the previous 6 months
  • Coagulation disorders preventing arthrocentesis
  • Incarceration or legal guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Vincent GOEB, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

July 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations

FR(1)