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

Primary Purpose

Fatigue, Primary Sjogren

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Anakinra
Placebo
Sponsored by
Helse Stavanger HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stavanger University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Anakinra

Placebo

Arm Description

Anakinra self-administered s.c. in a dose of 100mg daily

Placebo self-adminsitered s.c in a dose 0.67ml daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Inflammatory cytokines and measures of oxidative stress

Full Information

First Posted
May 20, 2008
Last Updated
August 18, 2015
Sponsor
Helse Stavanger HF
Collaborators
University of Oslo, University of Stavanger
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1. Study Identification

Unique Protocol Identification Number
NCT00683345
Brief Title
Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome
Official Title
Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
University of Oslo, University of Stavanger

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Primary Sjogren

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anakinra
Arm Type
Active Comparator
Arm Description
Anakinra self-administered s.c. in a dose of 100mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo self-adminsitered s.c in a dose 0.67ml daily
Intervention Type
Drug
Intervention Name(s)
Anakinra
Other Intervention Name(s)
Kineret
Intervention Description
Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline 0.9%
Intervention Description
Saline 0.67 ml daily subcutaneously as placebo drug.
Primary Outcome Measure Information:
Title
Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Inflammatory cytokines and measures of oxidative stress
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roald Omdal, PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
ZIP/Postal Code
N-4068
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22253903
Citation
Norheim KB, Harboe E, Goransson LG, Omdal R. Interleukin-1 inhibition and fatigue in primary Sjogren's syndrome--a double blind, randomised clinical trial. PLoS One. 2012;7(1):e30123. doi: 10.1371/journal.pone.0030123. Epub 2012 Jan 10.
Results Reference
derived

Learn more about this trial

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

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