MedDataX Logo

Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome

NCT ID: NCT01730495

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Fatigue Syndrome Myalgic Encephalomyelitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Etanercept

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etanercept

Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)
* moderate and serious CFS/ME severity
* age 18-66 years
* informed consent

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Øystein Fluge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Oncology and Medical Physics, Haukeland University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway

Bergen, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22039471 (View on PubMed)

Fluge 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.

Reference Type BACKGROUND
PMID: 19566965 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-006069-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2011/2500

Identifier Type: -

Identifier Source: org_study_id