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

This study has been completed.
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00848692
First received: February 19, 2009
Last updated: June 1, 2011
Last verified: June 2011
History of Changes
  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 2
Phase 3

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:

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):

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 May 21, 2013