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

Phase 2

Completed

• Conditions: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome
• Interventions: Drug: Rituximab

• Registration Number: NCT01156909
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Study Start: 2010-10
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-29
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• patients with CFS
• age 18-66 years
• informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab	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.

Primary Outcome Measures

Name	Time	Method
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Oncology, Haukeland University Hospital; 🇳🇴 Bergen, Norway