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

• ClinicalTrials.gov Identifier: NCT01730495
• Recruitment Status: Terminated
• First Posted: November 21, 2012
• Last Update Posted: December 2, 2015
• Sponsor: Haukeland University Hospital
• Information provided by (Responsible Party): Haukeland University Hospital

Tracking Information

• First Submitted Date: November 8, 2012
• First Posted Date: November 21, 2012
• Last Update Posted Date: December 2, 2015
• Study Start Date: October 2012
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 15, 2012)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 15, 2012)

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. ]

The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Chronic Fatigue Syndrome
• Myalgic Encephalomyelitis

Intervention

Drug: Etanercept

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

Study Arms

Experimental: Etanercept

Intervention: Drug: Etanercept

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.
• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 29, 2014): 4
• Original Estimated Enrollment (submitted: November 15, 2012): 15
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 66 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT01730495
• Other Study ID Numbers: 2011/2500; 2011-006069-16 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Haukeland University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Haukeland University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Haukeland University Hospital
• Verification Date: November 2015