Fibrocytes in Early and Longstanding Rheumatoid Arthritis

NCT02652299 | Completed

• 1 other identifier: S-20140062
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will focus on a rare cell population called fibrocytes in peripheral blood and synovial tissue in Rheumatoid Arthritis (RA). One group of patients with early RA and one group with long-standing RA. Both groups will be followed for 6 months. After informed and written consent a control groups is also formed: One for synovial biopsies for patients undergoing a routine arthroscopy, where a peripheral blood sample is also taken. The hypothesis is that fibrocytes are present in the blood and synovial tissue in RA. Patients with early and long-standing RA have higher concentrations of fibrocytes in peripheral blood and synovial tissue compared to a control groups. Levels of fibrocytes in peripheral blood and synovial tissue are correlated with RA disease activity measures and imaging findings.

Conditions

Rheumatoid Arthritis

Keywords

Fibrocytes; Synovial biopsy

Outcome Measures

Primary Outcomes (1)

• Fibrocytes in the peripheral blood.

  Compare level of fibrocytes (Fibrocytes/uL) in peripheral blood between the group of healthy controls and patients with early and long-standing RA. Compare level of fibrocytes (Fibrocytes/uL) at start of observation to end of observation in both RA groups.

  6 months

Secondary Outcomes (2)

• Interstitial lung disease and fibrocyte level.

  6 months

• Fibrocytes and RA disease activity by imaging, and synovial tissue analysis.

  6 months

Other Outcomes (1)

• Fibrocytes in the synovial tissue.

  6 months

Study Arms (3)

Early Rheumatoid Arthritis group

Following informed written consent, 20 patients with early RA will be enrolled from Odense University Hospital (OUH) during a 12 month period

Biological: Synovial biopsy

Longstanding Rheumatoid Arthritis group

Following informed written consent, 20 patients with longstanding RA will be enrolled from Odense University Hospital (OUH) during a 12 month period

Biological: Synovial biopsy

Control group: Synovial tissue and peripheral blood

20 Non-RA patients who are referred to arthroscopy in a joint of the hand at OUH Department of Orthopedics, Section of hand surgery, are asked to participate by the surgeon at the first ambulatory consultation. Following informed written consent, MRI of hand, a blood sample and synovial biopsies, will be used as control for synovial and plasma fibrocyte levels. The synovial biopsies will be obtained during the planned arthroscopy.

Biological: Synovial biopsy

Interventions

Synovial biopsy BIOLOGICAL

Synovial tissue for analysis and biobank.

Control group: Synovial tissue and peripheral blood; Early Rheumatoid Arthritis group; Longstanding Rheumatoid Arthritis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Following informed written consent, RA patients will be enrolled from Odense University Hospital (OUH) during a 12 month period.

You may qualify if:

• Patients with newly diagnosed RA (according to 2010 classification criteria) who have been diagnosed ≤ 6 months, and who have at least one swollen joint in hands/fingers.
• Patients with longstanding RA (\>5 years duration).
• Ability and willingness to give written informed consent and to meet the requirements of this protocol.

You may not qualify if:

• Age \< 18 years.
• Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis or primary vasculitis.
• History of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, spondyloarthropathy, Lyme disease).
• Allergy to local aesthetics.
• Hereditary or acquired (e.g. Anticoagulant Treatment, apart from low dose aspirin) coagulation abnormality.
• Prednisolone above 7.5 mg/day
• Skin pathology at site of joint biopsy.
• Obesity, BMI \> 30.
• Functional class IV as defined by the criteria for classification of functional status in RA.
• Heart failure (NYHA class III/IV), immunodeficiency, current or past malignant disease (except for non-melanoma skin cancer), recurrent or chronic infections (viral, fungal or bacterial), inflammatory bowel disease, myeloproliferative disorder or other bone marrow disease.
• Severe nervous system, liver, pulmonary, renal or endocrine disease (including Type 1 diabetes, stable type 2 diabetes is allowable).

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Just SA, Nielsen C, Werlinrud JC, Larsen PV, Hejbol EK, Tenstad HB, Daa Schroder H, Barington T, Torfing T, Humby F, Lindegaard H. Fibrocytes in early and long-standing rheumatoid arthritis: a 6-month trial with repeated synovial biopsy, imaging and lung function test. RMD Open. 2021 Mar;7(1):e001494. doi: 10.1136/rmdopen-2020-001494.

  PMID: 33674419 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood, Synovial tissue biopsies

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Søren Andreas Just, MD

  Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: January 11, 2016
• Study Start: March 1, 2016
• Primary Completion: April 4, 2018
• Study Completion: April 4, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

DK (1)