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NCT Number: NCT01156909

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

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.

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Myalgic Encephalomyelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, Haukeland University Hospital

Bergen, N-5021, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

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.

Primary outcomes

  1. 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.

    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 outcomes

  1. 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

    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)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 5, 2010
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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