B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome

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Brief Title

B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome

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

Brief Summary

      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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.

Secondary Outcome

 Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.

Condition

Chronic Fatigue Syndrome

Intervention

Rituximab

Study Arms / Comparison Groups

 Rituximab
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

29

Start Date

October 2010

Completion Date

February 2014

Primary Completion Date

February 2014

Eligibility 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
      

Gender

All

Ages

18 Years - 66 Years

Accepts Healthy Volunteers

No

Contacts

Olav Mella, PhD, MD, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT01156909

Organization ID

2010/1318


Responsible Party

Sponsor

Study Sponsor

Haukeland University Hospital


Study Sponsor

Olav Mella, PhD, MD, Principal Investigator, Haukeland University Hospital


Verification Date

August 2014