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

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Brief Title

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

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.

Brief 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 subcutaneous injections.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.

Secondary Outcome

 Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.

Condition

Chronic Fatigue Syndrome

Intervention

Etanercept

Study Arms / Comparison Groups

 Etanercept
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

4

Start Date

October 2012

Completion Date

August 2014

Primary Completion Date

August 2014

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 66 Years

Accepts Healthy Volunteers

No

Contacts

Øystein Fluge, MD, PhD, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT01730495

Organization ID

2011/2500

Secondary IDs

2011-006069-16

Responsible Party

Sponsor

Study Sponsor

Haukeland University Hospital


Study Sponsor

Øystein Fluge, MD, PhD, Principal Investigator, Dept. of Oncology and Medical Physics, Haukeland University Hospital


Verification Date

November 2015