Status:
UNKNOWN
Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission.
Lead Sponsor:
Hospital of Prato
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Interleukin-6 (IL-6), a pro-inflammatory cytokine, has been found to have a crucial role in the pathogenesis of Giant cel arteritis (GCA). Based on this rationale, several recent studies demonstrated ...
Detailed Description
Study design. Open-label, prospective, pilot study on patients with giant cell arteritis (GCA) resistant to corticosteroids (CS) . Setting. Rheumatology department, Hospital of Prato, Prato, Italy. T...
Eligibility Criteria
Inclusion
- \- All consecutive patients meeting the 1990 ACR classification criteria for GCA.
Exclusion
- Corticosteroid treatment during the previous 6 months.
- Uncontrolled diabetes.
- Uncontrolled hypertension.
- History of cancer within the past 5 years.
- History of frequent infections in the past.
- Positivity of screening procedures for latent tuberculosis infection.
- Uncontrolled dyslipidemia at baseline.
- Known intestinal diverticulosis.
- Concomitant hematologic disorders.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03244709
Start Date
January 1 2015
End Date
December 31 2017
Last Update
August 10 2017
Active Locations (1)
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1
Fabrizio Cantini
Prato, Tuscany, Italy, 59100