Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome
Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome
4 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 20, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 19, 2015
August 1, 2015
2.2 years
May 20, 2008
August 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale
4 weeks
Secondary Outcomes (1)
Inflammatory cytokines and measures of oxidative stress
4 weeks
Study Arms (2)
Anakinra
ACTIVE COMPARATORAnakinra self-administered s.c. in a dose of 100mg daily
Placebo
PLACEBO COMPARATORPlacebo self-adminsitered s.c in a dose 0.67ml daily
Interventions
Eligibility Criteria
You may qualify if:
- Primary Sjøgrens Syndrome according to the European-American criteria
- Age 18-80 years
- Written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Stavanger HFlead
- University of Oslocollaborator
- University of Stavangercollaborator
Study Sites (1)
Stavanger University Hospital
Stavanger, N-4068, Norway
Related Publications (1)
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.
PMID: 22253903DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roald Omdal, PhD
Helse Stavanger HF
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2008
First Posted
May 23, 2008
Study Start
January 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
August 19, 2015
Record last verified: 2015-08