Rheumatoid Arthritis Clinical Trial
Official title:
Fibrocytes in Early and Longstanding Rheumatoid Arthritis
NCT number | NCT02652299 |
Other study ID # | S-20140062 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | April 4, 2018 |
Verified date | March 2019 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 4, 2018 |
Est. primary completion date | April 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. Patients with longstanding RA (>5 years duration). 3. Ability and willingness to give written informed consent and to meet the requirements of this protocol. Exclusion criteria 1. Age < 18 years. 2. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis or primary vasculitis. 3. History of or current inflammatory joint disease other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, spondyloarthropathy, Lyme disease). 4. Allergy to local aesthetics. 5. Hereditary or acquired (e.g. Anticoagulant Treatment, apart from low dose aspirin) coagulation abnormality. 6. Prednisolone above 7.5 mg/day 7. Skin pathology at site of joint biopsy. 8. Obesity, BMI > 30. 9. Functional class IV as defined by the criteria for classification of functional status in RA. 10. 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. 11. Severe nervous system, liver, pulmonary, renal or endocrine disease (including Type 1 diabetes, stable type 2 diabetes is allowable). 12. Major surgery within 8 weeks. Laboratory exclusion Criteria Platelet count <100 x 109 /L or Haemoglobin <5 mmol/L or White blood cells <3 x 109/L or estimated Glomerular Filtration Rate (eGFR) <60. |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Fibrocytes in the synovial tissue. | Compare level of fibrocytes in synovial tissue (Fibrocytes/mm3) between healthy controls and RA groups. Compare level of fibrocytes in synovial tissue between RA groups, at start of observation to biopsy at end of observation (time 6 months). | 6 months | |
Primary | 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 | Interstitial lung disease and fibrocyte level. | Is the fibrocyte level in peripheral blood at presentation correlated with signs of beginning interstitial lung disease, defined as a reduction in the Carbon monoxide diffusion capacity (as mL/min/mm Hg and as a percentage of a predicted value) measured by a lung function test at presentation and at the end of the 6 months period. | 6 months | |
Secondary | Fibrocytes and RA disease activity by imaging, and synovial tissue analysis. | Fibrocyte levels are correlated to disease activity measured by imaging findings on x-ray (Larsen Score), ultrasound (Synovitis and Doppler Score (0-3)) and MRI (RAMRIS score) and degree of synovial that inflammation. | 6 months |
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