FatiguePhase 2NCT00683345
Fatigue and Interleukin-1 (IL-1) Blockade in Primary Sjøgrens Syndrome
A Phase 2 study testing Anakinra in people with Fatigue and Primary Sjogren, run by Helse Stavanger HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fatigue, Primary Sjogren
- What is being tested?
- Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Sjøgrens Syndrome according to the European-American criteria
- Age 18-80 years
- Written informed consent
Who cannot join
- Hyper- og hypothyreosis
- Malignant disease
- Parkinsons disease
- Multiple sclerosis
- Conditions or diseases where Anakinra is contraindicated
- Mental depression (BDI >13)
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- Neutropenia (<1.5*10.9)
- Frequent infections
- Pregnancy, lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome
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.
Read the detailed description
A double-blind, placebo-controlled, parallel study of the effect on fatigue of daily injections of Anakinra for one month.
- Conditions
- Fatigue, Primary Sjogren
- Being tested
- Anakinra, Placebo
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret
Anakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks.
PlaceboDrug
Also called Saline 0.9%
Saline 0.67 ml daily subcutaneously as placebo drug.
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Active comparator | Anakinra self-administered s.c. in a dose of 100mg daily Receives: Drug: Anakinra |
| Placebo | Placebo comparator | Placebo self-adminsitered s.c in a dose 0.67ml daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale
Measured: 4 weeks
Secondary outcomes (1)
Inflammatory cytokines and measures of oxidative stress
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- University of Oslo, University of Stavanger
- Responsible party
- Sponsor
- Investigators
- Roald Omdal, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683345
- Sponsor's protocol ID
- P REK NORD 60/2007
- Other IDs
- 2007-000475-41, 17772, 07/03834-7
- Status last verified
- Aug 2015
- First submitted
- 20 May 2008
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22253903
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue and IL-1 Blockade in Primary Sjøgrens Syndrome
- ClinicalTrials.gov ID
- NCT00683345
- Acronym / sponsor ID
- P REK NORD 60/2007
- Conditions
- Fatigue, Primary Sjogren
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- University of Oslo, University of Stavanger
- Study start
- Jan 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Active comparator | Drug: AnakinraAnakinra self-administered s.c. in a dose of 100mg daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo self-adminsitered s.c in a dose 0.67ml daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary Sjøgrens Syndrome according to the European-American criteria
- Age 18-80 years
- Written informed consent
Key exclusion criteria (9 listed)
- Hyper- og hypothyreosis
- Malignant disease
- Parkinsons disease
- Multiple sclerosis
- Conditions or diseases where Anakinra is contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnakinraAlso: KineretAnakinra 0.67 ml (100 mg) daily subcutaneously for 4 weeks. | Drug | Anakinra |
| PlaceboAlso: Saline 0.9%Saline 0.67 ml daily subcutaneously as placebo drug. | Drug | Placebo |
Primary outcome
Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale
Time frame: 4 weeks
1 secondary outcome
Inflammatory cytokines and measures of oxidative stress
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Derived from this study: PubMed 22253903Norheim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roald Omdal, PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra in people with Fatigue and Primary Sjogren, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue as measured by Fatigue Severity Scale and a visual analogue fatigue scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00683345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015; AzTrials last refreshed its copy on 6 Nov 2026.