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

Primary Purpose

Interstitial Lung Diseases, Rheumatoid Arthritis, Asthma

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fibrocyte measurement and lung function test.
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Interstitial Lung Diseases focused on measuring Fibrocytes, Interstitial Lung Diseases, Rheumatoid Arthritis, Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fibrocyte measurement and lung function test

Arm Description

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.

Outcomes

Primary Outcome Measures

Measure fibrocytes in peripheral blood.
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).

Secondary Outcome Measures

Compare circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of fibrocytes in cultured cells (fibrocytes/cultured peripheral blood mononuclear cells).
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.
Fibrocytes and lung diffusion capacity.
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).
Fibrocytes and rheumatoid arthritis
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).

Full Information

First Posted
March 13, 2016
Last Updated
April 20, 2017
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02711657
Brief Title
Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.
Official Title
Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study Fibrocytes in patients with Rheumatoid Arthritis, Interstitial lung disease and severe asthma and healthy controls.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Diseases, Rheumatoid Arthritis, Asthma
Keywords
Fibrocytes, Interstitial Lung Diseases, Rheumatoid Arthritis, Asthma

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
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrocyte measurement and lung function test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fibrocyte measurement and lung function test.
Primary Outcome Measure Information:
Title
Measure fibrocytes in peripheral blood.
Description
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).
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Compare circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of fibrocytes in cultured cells (fibrocytes/cultured peripheral blood mononuclear cells).
Description
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.
Time Frame
Baseline
Title
Fibrocytes and lung diffusion capacity.
Description
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).
Time Frame
Baseline
Title
Fibrocytes and rheumatoid arthritis
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Andreas Just, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28720095
Citation
Just SA, Lindegaard H, Hejbol EK, Davidsen JR, Bjerring N, Hansen SWK, Schroder HD, Hansen IMJ, Barington T, Nielsen C. Fibrocyte measurement in peripheral blood correlates with number of cultured mature fibrocytes in vitro and is a potential biomarker for interstitial lung disease in Rheumatoid Arthritis. Respir Res. 2017 Jul 18;18(1):141. doi: 10.1186/s12931-017-0623-9.
Results Reference
derived

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

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