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

Fatigue Clinical Trial

Official title:

Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683345
• Other study ID #: P REK NORD 60/2007
• Secondary ID: 2007-000475-4117
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2008
• Last updated: August 18, 2015
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2015
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Description:

A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Primary Sjogren
• Sjogren's Syndrome

Intervention

Drug:
• Anakinra
Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.
• Placebo
Saline 0.67 ml daily subcutaneously as placebo drug.

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
Helse Stavanger HF	University of Oslo, University of Stavanger

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale		4 weeks	No
Secondary	Inflammatory cytokines and measures of oxidative stress		4 weeks	No