NCT00683345

Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome

Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fatigue
• Primary Sjogren

Interventions

Type	Name	Description
DRUG	Anakinra	Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.
DRUG	Placebo	Saline 0.67 ml daily subcutaneously as placebo drug.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-05-23
• Last updated: 2015-08-19

Locations

1 site across 1 country: Norway