Drug Intervention in Chronic Fatigue Syndrome (KTS-1-2008)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Chronic Fatigue Syndrome	Drug: Rituximab; Drug: Saline (NaCl 0,9 %) (placebo)	Phase 2; Phase 3

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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.
Study Start Date :	June 2008
Actual Primary Completion Date :	June 2010
Actual Study Completion Date :	June 2010

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. doi: 10.1371/journal.pone.0026358. 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
First Posted:	February 20, 2009
Last Update Posted:	June 2, 2011
Last Verified:	June 2011

Keywords provided by Haukeland University Hospital:

Chronic Fatigue Syndrome; CFS; Myalgic Encephalomyelitis	Rituximab; B-lymphocyte depletion; B-cell depletion

Additional relevant MeSH terms:

Syndrome; Fatigue; Fatigue Syndrome, Chronic; Disease; Pathologic Processes; Signs and Symptoms; Virus Diseases; Muscular Diseases; Musculoskeletal Diseases	Encephalomyelitis; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Rituximab; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents