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

This study has been completed.
Sponsor:
Collaborators:
University of Oslo
University of Stavanger
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00683345
First received: May 20, 2008
Last updated: September 9, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Fatigue
Primary Sjogren
 Drug: Anakinra
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome

Resource links provided by NLM:

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

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory cytokines and measures of oxidative stress [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683345

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

No publications provided by Helse Stavanger HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Roald Omdal, Prof of Medicine, Stavanger University Hospital
ClinicalTrials.gov Identifier: NCT00683345     History of Changes
Other Study ID Numbers: P REK NORD 60/2007, 2007-000475-41, 17772, 07/03834-7
Study First Received: May 20, 2008
Last Updated: September 9, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Fatigue
Sjogren's Syndrome
Signs and Symptoms
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013