Status:
UNKNOWN
Biomarkers in Rheumatoid Arthritis Treated With Anti-interleukin-6 Therapy
Lead Sponsor:
University Hospital, Caen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The use of anti-interleukin (IL)-6 therapy, including tocilizumab, in rheumatoid arthritis or giant cell arteritis, led to the improvement or even control of disease in some patients for whom no furth...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients:
- Adult patients suffering from rheumatoid arthritis diagnosed according to American College of Rheumatology/European League Against Rheumatism 2010 criteria and requiring an anti-IL-6 therapy by intravenous or subcutaneous injection
- Non-opposition of the patient
- Inclusion Criteria for healthy controls:
- Adult patients not suffering from acute or chronic inflammatory disease at inclusion (normal C-reactive protein and fibrinogen levels)
- Non-opposition of the subject
- Exclusion Criteria for patients:
- Patient is already treated with anti-IL-6 therapy
- Pregnancy or breastfeeding women
- Person under judicial protection, guardianship
- Patient suffering from another chronic inflammatory disease
- Patient suffering from another acute inflammatory disease at inclusion
- Person not beneficiaries of the social security system
- Exclusion Criteria for healthy controls:
- Pregnancy or breastfeeding women
- Person under judicial protection, guardianship
- Patient suffering from acute or chronic inflammatory disease at inclusion
- Previous history of chronic inflammatory disease
- Ongoing anti-inflammatory or immunosuppressive treatment, except aspirin and derivatives at anti-platelet aggregation dose, non-steroidal anti-inflammatory drugs stopped for 10 days or systemic steroids stopped for 1 month
- Person not beneficiaries of the social security system
Exclusion
Key Trial Info
Start Date :
February 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 2 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04281602
Start Date
February 18 2020
End Date
May 2 2024
Last Update
March 4 2020
Active Locations (1)
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1
CHU de Caen Normandie
Caen, France, 14000