NCT01730495

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

November 8, 2012

Last Update Submit

November 30, 2015

Conditions

Chronic Fatigue SyndromeMyalgic Encephalomyelitis

Keywords

Chronic fatigue syndromeCFSMyalgic Encephalomyelitis (ME)CFS/METumor necrosis factor-alphaTNF-alphaEtanercept

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

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

    At 3, 6, 9, 12 months after start of intervention.

Study Arms (1)

Etanercept

EXPERIMENTAL
Drug: Etanercept

Interventions

EtanerceptDRUG

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

Etanercept

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bergen, N-5021, Norway

Location

Related Publications (2)

  • 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.

    PMID: 22039471BACKGROUND

  • 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.

    PMID: 19566965BACKGROUND

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Øystein Fluge, MD, PhD

    Dept. of Oncology and Medical Physics, Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 21, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

NO(1)