Status:
COMPLETED
Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome
Lead Sponsor:
Helse Stavanger HF
Collaborating Sponsors:
University of Oslo
University of Stavanger
Conditions:
Fatigue
Primary Sjogren
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Fatigue is a prevalent phenomenon in Primary Sjøgrens syndrome (PSS). Observations indicate that the cytokine IL-1 is of importance for this phenomenon. In this study the investigators block IL-1 by g...
Detailed Description
A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.
Eligibility Criteria
Inclusion
- Primary Sjøgrens Syndrome according to the European-American criteria
- Age 18-80 years
- Written informed consent
Exclusion
- Hyper- og hypothyreosis
- Malignant disease
- Parkinsons disease
- Multiple sclerosis
- Conditions or diseases where Anakinra is contraindicated
- Mental depression (BDI \>13)
- Neutropenia (\<1.5\*10.9)
- Frequent infections
- Pregnancy, lactating women.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00683345
Start Date
January 1 2008
End Date
April 1 2010
Last Update
August 19 2015
Active Locations (1)
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1
Stavanger University Hospital
Stavanger, Norway, N-4068