Drug Intervention in Chronic Fatigue Syndrome - Full Text View

Sponsor:	Haukeland University Hospital
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00848692

Purpose

Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.

The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.

Condition	Intervention	Phase
Chronic Fatigue Syndrome	Drug: Rituximab Drug: Saline (NaCl 0,9 %) (placebo)	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.

Resource links provided by NLM:

MedlinePlus related topics: Chronic Fatigue Syndrome Fatigue

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:

Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: 3 months after intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes [ Time Frame: 2, 4, 6, 8, 10, 12 months after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	June 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Rituximab	Drug: Rituximab Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
Placebo Comparator: 2 Placebo (saline)	Drug: Saline (NaCl 0,9 %) (placebo) Two infusions of saline (NaCl 0,9 %) given two weeks apart

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

verified chronic fatigue syndrome (CDC-criteria)
age >18 and <60 years
informed consent

Exclusion Criteria:

pregnancy or lactation
previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
previous long-term use of immunosuppressive drugs
previous exposure to rituximab
endogenous depression
multi-allergy with risk of serious drug reaction
reduced renal function (creatinin > 1.2 x UNL)
reduced liver function (bilirubin or transaminases > 1.5 x UNL)
known HIV infection
signs of active viral infection by pretreatment investigations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848692

Locations

Norway
Department of Oncology and Medical Physics, Haukeland University Hospital
Bergen, Norway, N-5021

Sponsors and Collaborators

Haukeland University Hospital

Investigators

Principal Investigator:

Olav Mella, MD, PhD

Department of Oncology and Medical Physics, Haukeland University Hospital

More Information

No publications provided by Haukeland University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Oct 19.

Responsible Party:	Olav Mella, Professor, Department Director, Department of Oncology and Medical Physics, Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00848692 History of Changes
Other Study ID Numbers:	18257, EudraCT: 2007-007973-22
Study First Received:	February 19, 2009
Last Updated:	June 1, 2011
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Haukeland University Hospital:

Chronic Fatigue Syndrome
CFS
Myalgic Encephalomyelitis

Rituximab
B-lymphocyte depletion
B-cell depletion

Additional relevant MeSH terms:

Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases

Neuromuscular Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012