Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøg... | NCT00683345

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

NCT00683345

Sponsor

Helse Stavanger HF

Status

Completed

Last Update Posted

Aug 19, 2015Estimated

Enrollment

28Actual

Phase

Phase 2

Conditions

Fatigue
Primary Sjogren

Interventions

Anakinra
Placebo

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
2007-000475-41	EudraCT Number
17772	Other Identifier	NSD
07/03834-7	Other Identifier	Norwegian Medicines Agency

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

May 20, 2008

First Submission Date that Met QC Criteria

May 22, 2008

First Posted Date

May 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2015

Last Update Posted Date

Aug 19, 2015Estimated

Name	Class
University of Oslo	OTHER
University of Stavanger	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anakinra	Active Comparator	Anakinra self-administered s.c. in a dose of 100mg daily	Drug: Anakinra
Placebo	Placebo Comparator	Placebo self-adminsitered s.c in a dose 0.67ml daily	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anakinra	Drug	Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.	Anakinra

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roald Omdal, PhD	Helse Stavanger HF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stavanger University Hospital		Stavanger		N-4068	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22253903	Derived	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.

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D053590	Interleukin 1 Receptor Antagonist Protein
D012965	Sodium Chloride

ID	Term
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins