Skip to main content
OpenTrials
Completed

NCT Number: NCT02711657

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

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibrocyte measurement and lung function test.

Other

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 17, 2016
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.