Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.

April 20, 2017 updated by: Søren Andreas Just, Odense University Hospital
To study Fibrocytes in patients with Rheumatoid Arthritis, Interstitial lung disease and severe asthma and healthy controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: 1) To demonstrate that circulating CD45+ CD34+ CD11b+ cells can express Procollagen 1 and thereby show that these markers can be used to identify circulating fibrocytes. 2) To measure the levels of circulating CD45+, CD34+, CD11b+ cells in patients with RA, Fibrotic ILDs, severe asthma and in healthy controls (HC). 3) To compare the levels with number of peripheral blood mononuclear cells (PBMC) that differentiate to mature fibrocytes in vitro.

Method: The CD45+, CD34+, CD11b+ cells from 4 patients were isolated by cell sorting, and stained for Procollagen. 30 patients (10 of each RA, fibrotic ILDs: IPF or non-specific interstitial pneumonitis (NSIP), severe asthma) and 10 HC were included. Current medication, disease activity, lung function and radiographic data were collected. In 100 µL of lysed blood cells were enumerated by flowcytometry. Further, PBMC were isolated and cultured for 5 days. Coverslips from two wells were stained and mature fibrocytes counted and reported as fibrocytes per 106 PBMC originally added to the well.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 10 patient with rheumatoid arthritis.
  • 10 patient with rheumatoid arthritis and interstitial lung disease
  • 10 patients with interstitial lung disease (idiopathic pulmonary fibrosis or nonspecific interstitial pneumonia)
  • 10 patients with asthma
  • 10 healthy volunteers

Exclusion Criteria:

  • Unable to sign written informed consent to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fibrocyte measurement and lung function test
All participants has a peripheral blood sample taken, where fibrocytes are measured using flowcytometry. Further peripheral blood mononuclear cells (PBMC) are isolated and cultured. All, except healthy controls, have their lung function measured.
Other: Fibrocyte measurement and lung function test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure fibrocytes in peripheral blood.
Time Frame: Baseline
To measure the levels of circulating CD45+, CD34+, CD11b+ cells (cells/uL) in patients with RA, Fibrotic ILDs, severe asthma and in healthy controls (HC).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of fibrocytes in cultured cells (fibrocytes/cultured peripheral blood mononuclear cells).
Time Frame: Baseline
To compare the levels of circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of peripheral blood mononuclear cells (PBMC) that differentiate to mature fibrocytes in vitro.
Baseline
Fibrocytes and lung diffusion capacity.
Time Frame: Baseline
Is the level of fibrocytes in peripheral blood (cells/uL) correlated signs of interstitial lung disease in a lung function measured by diffusing capacity for carbon monoxide (DLCO) (mmol CO per min per kPa).
Baseline
Fibrocytes and rheumatoid arthritis
Time Frame: Baseline
Is the level of fibrocytes in peripheral blood (cells/uL) correlated to disease activity in rheumatoid arthritis, measured by disease activity score in 28 joints (DAS28).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 13, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20150172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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