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

Chronic Fatigue Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01730495
• Other study ID #: 2011/2500
• Secondary ID: 2011-006069-16
• Status: Terminated
• Phase: Phase 2
• First received: November 8, 2012
• Last updated: November 30, 2015
• Start date: October 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical 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 subcutaneous injections.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Myalgia
• Myalgic Encephalomyelitis
• Necrosis
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Norway	Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Fluge Ø, Bruland O, Risa K, Storstein A, Kristoffersen EK, Sapkota D, Næss 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. — View Citation

Fluge Ø, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.	Yes
Secondary	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.	At 3, 6, 9, 12 months after start of intervention.	Yes