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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00683345
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : August 19, 2015
University of Oslo
University of Stavanger
Information provided by (Responsible Party):
Helse Stavanger HF

Brief 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.

Condition or disease Intervention/treatment Phase
Fatigue Primary Sjogren Drug: Anakinra Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra
U.S. FDA Resources

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 Name: 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 Name: Saline 0.9%

Primary Outcome Measures :
  1. Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Inflammatory cytokines and measures of oxidative stress [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00683345

Stavanger University Hospital
Stavanger, Norway, N-4068
Sponsors and Collaborators
Helse Stavanger HF
University of Oslo
University of Stavanger
Principal Investigator: Roald Omdal, PhD Helse Stavanger HF

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Helse Stavanger HF Identifier: NCT00683345     History of Changes
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 )
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Sjogren's Syndrome
Signs and Symptoms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents