Biomarkers in Chronic Arthritis

Chronic Arthritis Clinical Trial

Official title:

Evaluation of Predictive Genetic Markers of Response to Biologic Therapies in Chronic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909998
• Other study ID #: 8359
• Secondary ID: 2008-A01087-48
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 19, 2016
• Start date: October 2008
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Chronic Arthritis

Intervention

Other:
• Blood sample
Conservation at the end of the blood sample

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of responsive patients with a given polymorphism (%)		At the inclusion	No
Secondary	Distribution of patients with a given biotherapy (%)		At the inclusion	No
Secondary	Distribution of patients presenting a given polymorphism (%)		At the inclusion	No