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

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02711657

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Diseases Rheumatoid Arthritis Asthma	Other: Fibrocyte measurement and lung function test.	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Measure fibrocytes in peripheral blood. [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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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