Trial record 1 of 19 for:
Open Studies | "Fatigue Syndrome, Chronic"
Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome
This study is currently recruiting participants.
Verified November 2012 by Haukeland University Hospital
Sponsor:
Haukeland University Hospital
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01730495
First received: November 8, 2012
Last updated: November 15, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Fatigue Syndrome Myalgic Encephalomyelitis |
Drug: Etanercept |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Haukeland University Hospital:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Etanercept |
Drug: Etanercept
Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
|
Eligibility| Ages Eligible for Study: | 18 Years to 66 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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, mycophenolatemofetil, 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730495
Contacts
| Contact: Olav Mella, MD, PhD | 47 55972069 | olav.mella@helse-bergen.no |
| Contact: Øystein Fluge, MD, PhD | 47 55972010 | oystein.fluge@helse-bergen.no |
Locations
| Norway | |
| Dept. of Oncology and Medical Physics, Haukeland University Hospital Bergen, Norway | Recruiting |
| Bergen, Norway, N-5021 | |
| Contact: Olav Mella, MD, PhD 47 55972069 olav.mella@helse-bergen.no | |
| Contact: Øystein Fluge, MD, PhD 47 55972010 oystein.fluge@helse-bergen.no | |
| Principal Investigator: Øystein Fluge, MD, PhD | |
| Sub-Investigator: Olav Mella, MD, PhD | |
Sponsors and Collaborators
Haukeland University Hospital
Investigators
| Principal Investigator: | Øystein Fluge, MD, PhD | Dept. of Oncology and Medical Physics, Haukeland University Hospital |
More Information
Publications:
| Responsible Party: | Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT01730495 History of Changes |
| Other Study ID Numbers: | 2011/2500, 2011-006069-16 |
| Study First Received: | November 8, 2012 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Norway: Directorate of Health Norway: Norwegian Medicines Agency |
Keywords provided by Haukeland University Hospital:
|
Chronic fatigue syndrome CFS Myalgic Encephalomyelitis (ME) CFS/ME |
Tumor necrosis factor-alpha TNF-alpha Etanercept |
Additional relevant MeSH terms:
|
Fatigue Syndrome, Chronic Encephalomyelitis Fatigue Necrosis Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Pathologic Processes |
TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013