NCT02839278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

9.4 years

First QC Date

July 18, 2016

Last Update Submit

November 25, 2024

Conditions

Inflammation

Keywords

Immunomodulation

Outcome Measures

Primary Outcomes (1)

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

    24 months

Study Arms (1)

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

Blood sampleBIOLOGICAL
Immune-mediated inflammatory disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant woman
  • Subject without health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Besançon, France

Location

MeSH Terms

Conditions

Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

April 1, 2015

Primary Completion

September 2, 2024

Study Completion

September 2, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)