Biological Evaluation of a Novel Anti-inflammatory Treatm... | NCT02839278

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

NCT02839278

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Nov 27, 2024Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Inflammation

Interventions

Blood sample

Countries

France

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

Status Module

Record Verification Date

Nov 2024

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

Apr 2015

Primary Completion Date

Sep 2, 2024Actual

Completion Date

Sep 2, 2024Actual

First Submitted Date

Jul 18, 2016

First Submission Date that Met QC Criteria

Jul 18, 2016

First Posted Date

Jul 20, 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

Nov 25, 2024

Last Update Posted Date

Nov 27, 2024Actual

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

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immune-mediated inflammatory disease	Experimental	Patients with an immune-mediated inflammatory disease. A blood sample is achieved at T0 (no follow-up).	Biological: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Biological		Immune-mediated inflammatory disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of costimulatory molecules CD86, CD80, CD40 and class II (HLA-DR) on monocytes		24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Besançon			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided