Chronic Fatigue SyndromePhase 2NCT01730495
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
A Phase 2 study testing Etanercept in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly… Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2012to Aug 2014
- 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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)
- moderate and serious CFS/ME severity
- age 18-66 years
- informed consent
Who cannot join
- patients with fatigue, not fulfilling criteria for CFS
- pregnancy or lactation
- previous malignant disease, except basal cell carcinoma of skin and cervical carcinoma in situ
- previous long-term systemic treatment with immunosuppressive drugs such as cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive lunge disease.
- demyelinating disease, such as multiple sclerosis.
- heart failure.
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- endogenous depression.
- lack of ability to comply to the protocol.
- multi-allergy with risk of serious drug reaction
- reduced renal function (creatinine > 1.5 x UNL)
- reduced liver function (bilirubin or transaminases > 1.5 x UNL)
- HIV positivity. Evidence of clinically significant infection. Previous viral hepatitis with risk of reactivation. High risk of opportunistic infections. Latent tuberculosis must be treated before inclusion.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway
Bergen, N-5021
About this study
Official title: Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Moderate and Serious Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME), Including in Patients With no Clinical Response After B-lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab.
The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly subcutaneous injections.
- Being tested
- Etanercept
- Keywords
- Chronic fatigue syndrome, CFS, Myalgic Encephalomyelitis (ME), CFS/ME, Tumor necrosis factor-alpha, TNF-alpha, Etanercept
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Not described Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.
Measured: Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.
Secondary outcomes (1)
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.
Measured: At 3, 6, 9, 12 months after start of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: After inclusion of four patients, two experienced moderate worsening of symptoms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øystein Fluge, MD, PhD, Principal investigator, Dept. of Oncology and Medical Physics, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730495
- Sponsor's protocol ID
- 2011/2500
- Other IDs
- 2011-006069-16
- Status last verified
- Nov 2015
- First submitted
- 8 Nov 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.
PubMed 22039471Fluge O, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28. doi: 10.1186/1471-2377-9-28.
PubMed 19566965
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Moderate and Serious Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME), Including in Patients With no Clinical Response After B-lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab.
- ClinicalTrials.gov ID
- NCT01730495
- Acronym / sponsor ID
- 2011/2500
- Keywords
- Chronic fatigue syndrome, CFS, Myalgic Encephalomyelitis (ME), CFS/ME, Tumor necrosis factor-alpha, TNF-alpha, Etanercept
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After inclusion of four patients, two experienced moderate worsening of symptoms
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Nov 2012 (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.
The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly subcutaneous injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: Etanercept |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)
- moderate and serious CFS/ME severity
- age 18-66 years
- informed consent
Key exclusion criteria (12 listed)
- patients with fatigue, not fulfilling criteria for CFS
- pregnancy or lactation
- previous malignant disease, except basal cell carcinoma of skin and cervical carcinoma in situ
- previous long-term systemic treatment with immunosuppressive drugs such as cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive lunge disease.
- demyelinating disease, such as multiple sclerosis.
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 |
|---|---|---|
| EtanerceptWeekly subcutaneous injections of Etanercept 50 mg, for up to 12 months. | Drug | Etanercept |
Primary outcome
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Time frame: Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.
The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.
1 secondary outcome
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Time frame: At 3, 6, 9, 12 months after start of intervention.
Results and safety
The study was stopped early (reason given: After inclusion of four patients, two experienced moderate worsening of symptoms). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 22039471Fluge O, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Naess H, Dahl O, Nyland H, Mella O. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358. doi: 10.1371/journal.pone.0026358. Epub 2011 Oct 19.
- Background: PubMed 19566965Fluge O, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28. doi: 10.1186/1471-2377-9-28.
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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.
Øystein Fluge, MD, PhD principal investigator
Dept. of Oncology and Medical Physics, Haukeland University Hospital
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 Etanercept in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Haukeland University Hospital 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Dec 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. 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 was stopped early (reason given: After inclusion of four patients, two experienced moderate worsening of symptoms). Results are not available in the source record.
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?
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes. (time frame: Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.). 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 NCT01730495, which also lists 2 linked publications.
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 2 Dec 2015.