NCT02711657

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

March 13, 2016

Last Update Submit

April 20, 2017

Conditions

Interstitial Lung DiseasesRheumatoid ArthritisAsthma

Keywords

FibrocytesInterstitial Lung DiseasesRheumatoid ArthritisAsthma

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline

Secondary Outcomes (3)

  • Compare circulating CD45+, CD34+, CD11b+ cells (cells/uL) with number of fibrocytes in cultured cells (fibrocytes/cultured peripheral blood mononuclear cells).

    Baseline

  • Fibrocytes and lung diffusion capacity.

    Baseline

  • Fibrocytes and rheumatoid arthritis

    Baseline

Study Arms (1)

Fibrocyte measurement and lung function test

EXPERIMENTAL

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.

Interventions

Fibrocyte measurement and lung function test.OTHER
Fibrocyte measurement and lung function test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 28720095DERIVED

MeSH Terms

Conditions

Lung Diseases, InterstitialArthritis, RheumatoidAsthma

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivity

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • Søren Andreas Just, MD

    Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D. Student

Study Record Dates

First Submitted

March 13, 2016

First Posted

March 17, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

April 1, 2017

Last Updated

April 21, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)