Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome
- Registration Number
- NCT00683345
- Lead Sponsor
- Helse Stavanger HF
- 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 giving Anakinra (an IL-1 receptor antagonist) to patients with PSS.
- Detailed Description
A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Primary Sjøgrens Syndrome according to the European-American criteria
- Age 18-80 years
- Written informed consent
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Exclusion Criteria
- 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo self-adminsitered s.c in a dose 0.67ml daily Anakinra Anakinra Anakinra self-administered s.c. in a dose of 100mg daily
- Primary Outcome Measures
Name Time Method Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale 4 weeks
- Secondary Outcome Measures
Name Time Method Inflammatory cytokines and measures of oxidative stress 4 weeks
Trial Locations
- Locations (1)
Stavanger University Hospital
🇳🇴Stavanger, Norway