NCT02909998

Brief Summary

Use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

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

October 1, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

6.2 years

First QC Date

September 8, 2016

Last Update Submit

September 19, 2016

Conditions

Chronic Arthritis

Keywords

BiomarkersGeneticChronic arthritisTreatment

Outcome Measures

Primary Outcomes (1)

  • Proportion of responsive patients with a given polymorphism (%)

    At the inclusion

Secondary Outcomes (2)

  • Distribution of patients with a given biotherapy (%)

    At the inclusion

  • Distribution of patients presenting a given polymorphism (%)

    At the inclusion

Interventions

Blood sampleOTHER

Conservation at the end of the blood sample

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients referred for chronic arthritis

You may qualify if:

  • All patients treated with biotherapy may be included in this study with all information necessary for regular medical consultations (filling specific monitoring by GPs questionnaires), physical therapists visits, occupational therapists, psychologists.. etc

You may not qualify if:

  • Patients treated with biological therapy for non rheumatic disease
  • Other inflammatory diseases such as Crohn's disease
  • Refusal to participate in the collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ladhari C, Le Blay P, Vincent T, Larbi A, Rubenstein E, Lopez RF, Jorgensen C, Pers YM. Successful long-term remission through tapering tocilizumab infusions: a single-center prospective study. BMC Rheumatol. 2020 Feb 28;4:5. doi: 10.1186/s41927-019-0109-0. eCollection 2020.

    PMID: 32161846DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Isabelle TOUITOU, MD, PhD

    Montpellier Hospital University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 21, 2016

Study Start

October 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share