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Biomarkers in Chronic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909998
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment
Chronic Arthritis Other: Blood sample

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.

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Study Type : Observational
Actual Enrollment : 379 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Predictive Genetic Markers of Response to Biologic Therapies in Chronic Arthritis
Study Start Date : October 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis


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


Primary Outcome Measures :
  1. Proportion of responsive patients with a given polymorphism (%) [ Time Frame: At the inclusion ]

Secondary Outcome Measures :
  1. Distribution of patients with a given biotherapy (%) [ Time Frame: At the inclusion ]
  2. Distribution of patients presenting a given polymorphism (%) [ Time Frame: At the inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients referred for chronic arthritis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909998


Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Isabelle TOUITOU, MD, PhD Montpellier Hospital University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02909998    
Other Study ID Numbers: 8359
2008-A01087-48 ( Other Identifier: FRANCE: Agence française de Sécurité Sanitaire des Produits de Santé )
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Montpellier:
Biomarkers
Genetic
Chronic arthritis
Treatment
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases