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Completed

NCT Number: NCT00683345

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.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Primary Sjogren Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stavanger University Hospital

Stavanger, N-4068, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anakinra

Drug

Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.

Other names: Kineret

Placebo

Drug

Saline 0.67 ml daily subcutaneously as placebo drug.

Other names: Saline 0.9%

Primary outcomes

  1. Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale

    Time frame: 4 weeks

Secondary outcomes

  1. Inflammatory cytokines and measures of oxidative stress

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • University of Oslo
  • University of Stavanger

Registry information

Official study title

Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 23, 2008
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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