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

Primary Purpose

Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring Immunomodulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immune-mediated inflammatory disease

Arm Description

Patients with an immune-mediated inflammatory disease. A blood sample is achieved at T0 (no follow-up).

Outcomes

Primary Outcome Measures

Expression of costimulatory molecules CD86, CD80, CD40 and class II (HLA-DR) on monocytes

Secondary Outcome Measures

Full Information

First Posted
July 18, 2016
Last Updated
September 2, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02839278
Brief Title
Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases
Acronym
Super-Bio
Official Title
Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Immunomodulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immune-mediated inflammatory disease
Arm Type
Experimental
Arm Description
Patients with an immune-mediated inflammatory disease. A blood sample is achieved at T0 (no follow-up).
Intervention Type
Biological
Intervention Name(s)
Blood sample
Primary Outcome Measure Information:
Title
Expression of costimulatory molecules CD86, CD80, CD40 and class II (HLA-DR) on monocytes
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Perruche, Doctor
Email
sylvain.perruche@inserm.fr
First Name & Middle Initial & Last Name & Degree
Stéphanie François
Email
sfrancois@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Lucine Vuitton, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases

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