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

Sponsor

Haukeland University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01156909

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome Myalgic Encephalomyelitis	Drug: Rituximab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 66 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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