Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome|
- Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
- Inflammatory cytokines and measures of oxidative stress [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Anakinra
Anakinra self-administered s.c. in a dose of 100mg daily
Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.
Other Name: Kineret
Placebo Comparator: Placebo
Placebo self-adminsitered s.c in a dose 0.67ml daily
Saline 0.67 ml daily subcutaneously as placebo drug.
Other Name: Saline 0.9%
A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.
|Stavanger University Hospital|
|Stavanger, Norway, N-4068|
|Principal Investigator:||Roald Omdal, PhD||Helse Stavanger HF|