Biomarkers in Chronic Arthritis | NCT02909998

Studies
Biomarkers in Chronic Arthritis

NCT02909998

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Sep 21, 2016Estimated

Enrollment

379Actual

Phase

Not provided

Conditions

Chronic Arthritis

Interventions

Blood sample

Countries

Not provided

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

ID	Type	Description	Link
2008-A01087-48	Other Identifier	FRANCE: Agence française de Sécurité Sanitaire des Produits de Santé

Status Module

Record Verification Date

Sep 2016

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

Oct 2008

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Sep 8, 2016

First Submission Date that Met QC Criteria

Sep 19, 2016

First Posted Date

Sep 21, 2016Estimated

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 19, 2016

Last Update Posted Date

Sep 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Chronic arthritis in children and in adults represent a public health problem in number and difficulty of treatment. 30% of patients are non-responders and / or relapse upon discontinuation of treatment. Some of these treatments are not always well tolerated, sometimes with infectious complications including tuberculosis limiting the use of biological therapies. This study will validate a battery of genetic markers to predict responders biotherapy, determine the prognosis of patients, these treatments are reserved for the most severe forms, and thus improve the care of patients.

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

379Actual

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Other	Conservation at the end of the blood sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of responsive patients with a given polymorphism (%)		At the inclusion

Secondary Outcomes

Measure	Description	Time Frame
Distribution of patients with a given biotherapy (%)		At the inclusion
Distribution of patients presenting a given polymorphism (%)		At the inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients referred for chronic arthritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle TOUITOU, MD, PhD	Montpellier Hospital University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32161846	Derived	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.

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis