Clinical trial NCT02711657: Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.
Official title: Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Diseases
Rheumatoid Arthritis
Asthma
Keywords: Fibrocytes
Interstitial Lung Diseases
Rheumatoid Arthritis
Asthma
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Measure fibrocytes in peripheral blood.
timeFrame: Baseline
Secondary outcomes:
measure: Compare circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of fibrocytes in cultured cells (fibrocytes/cultured peripheral blood mononuclear cells).
timeFrame: Baseline
measure: Fibrocytes and lung diffusion capacity.
timeFrame: Baseline
measure: Fibrocytes and rheumatoid arthritis
timeFrame: Baseline
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Søren Andreas Just, MD
role: STUDY_CHAIR
References:
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.