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

August 18, 2015 updated by: Helse Stavanger HF

Fatigue and 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Stavanger, Norway, N-4068
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anakinra
Anakinra self-administered s.c. in a dose of 100mg daily
Drug: Anakinra
Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.
Other Names:
  • Kineret
Placebo Comparator: Placebo
Placebo self-adminsitered s.c in a dose 0.67ml daily
Drug: Placebo
Saline 0.67 ml daily subcutaneously as placebo drug.
Other Names:
  • Saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory cytokines and measures of oxidative stress
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

University of Oslo
University of Stavanger

Investigators

  • Principal Investigator: Roald Omdal, PhD, Helse Stavanger HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P REK NORD 60/2007
  • 2007-000475-41 (EudraCT Number)
  • 17772 (Other Identifier: NSD)
  • 07/03834-7 (Other Identifier: Norwegian Medicines Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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