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Trial record 2 of 3 for:    kts-1-2008
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B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01156909
First received: July 2, 2010
Last updated: August 29, 2014
Last verified: August 2014
History of Changes
  Purpose

Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.

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


Condition Intervention Phase
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
 Drug: Rituximab
 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: B-lymphocyte Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. An Open Label Phase II Study With Rituximab Induction and Maintenance Treatment

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: Major response of at least six weeks duration, independent on when occuring, during the follow-up period. ] [ Designated as safety issue: Yes ]
    The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 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, 10, 15, 20, 24, 30, 36 months after intervention ] [ Designated as safety issue: Yes ]
    The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion)
Enrollment: 29
Study Start Date: October 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
Rituximab induction using two infusions (500mg/m2, max 1000 mg) two weeks apart, followed by maintenance Rituximab infusions (500 mg/m2, max 1000 mg) after 3, 6, 10 and 15 months.
 Drug: Rituximab

Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months.

Approved amendment: for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.

  Eligibility
Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with CFS
  • 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 major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis
  • previous long-term use of immunosuppressive drugs, except steroids e.g. in obstructive lunge disease
  • endogenous depression
  • lack of ability to comply by the protocol
  • multi-allergy with risk of serious drug reaction
  • reduced renal function (creatinin > 1.5 x UNL)
  • reduced liver function (bilirubin or transaminases > 1.5 x UNL)
  • HIV positivity
  • evidence of clinically significant infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156909

Locations
Norway
Department of Oncology, Haukeland University Hospital
Bergen, Norway, N-5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Olav Mella, PhD, MD Haukeland University Hospital
  More Information

Publications:

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01156909     History of Changes
Other Study ID Numbers: 2010/1318
Study First Received: July 2, 2010
Last Updated: August 29, 2014
Health Authority: Norway: Directorate of Health

Keywords provided by Haukeland University Hospital:
Chronic fatigue syndrome
CFS
Myalgic encephalomyelitis
Rituximab
B-cell depletion

Additional relevant MeSH terms:
Encephalomyelitis
Fatigue
Fatigue Syndrome, Chronic
Syndrome
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Disease
Encephalitis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
 Neuromuscular Diseases
Pathologic Processes
Signs and Symptoms
Virus Diseases
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015