Fatigue, Primary Sjogren
Conditions
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.
Interventions
DRUGAnakinra
Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.
DRUGPlacebo
Saline 0.67 ml daily subcutaneously as placebo drug.
Sponsors
University of Oslo
University of Stavanger
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary Sjøgrens Syndrome according to the European-American criteria * Age 18-80 years * Written informed consent
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory cytokines and measures of oxidative stress | 4 weeks |
Countries
Norway
Outcome results
None listed