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Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases (Super-Bio)

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ClinicalTrials.gov Identifier: NCT02839278
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
The aim of the study is to investigate in vitro the impact of a novel anti-inflammatory treatment on costimulatory molecules expressed on monocytes.

Condition or disease Intervention/treatment Phase
Inflammation Biological: Blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases
Study Start Date : April 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Immune-mediated inflammatory disease
Patients with an immune-mediated inflammatory disease. A blood sample is achieved at T0 (no follow-up).
Biological: Blood sample



Primary Outcome Measures :
  1. Expression of costimulatory molecules CD86, CD80, CD40 and class II (HLA-DR) on monocytes [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Immune-mediated inflammatory disease (non-ST segment elevation myocardial infarction, Rheumatoid arthritis, Chronic obstructive pulmonary disease, Idiopathic pulmonary fibrosis, Crohn's disease, Ulcerative colitis, Cystic fibrosis, Psoriasis, Multiple sclerosis or major depressive episode)
  • Patient able to understand the reason of the study
  • Patient not opposed to the conservation of biological samples for scientific research

Exclusion Criteria:

  • Pregnant woman
  • Subject without health insurance

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): NCT02839278


Locations
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France
University Hospital Recruiting
Besançon, France
Contact: Sylvain Perruche, Doctor       sylvain.perruche@inserm.fr   
Contact: Stéphanie François       sfrancois@chu-besancon.fr   
Principal Investigator: Lucine Vuitton, Doctor         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02839278    
Other Study ID Numbers: P/2014/233
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Immunomodulation
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes