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

Chronic Fatigue Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156909
• Other study ID #: 2010/1318
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2010
• Last updated: August 29, 2014
• Start date: October 2010
• Est. completion date: February 2014

Study information

• Verified date: August 2014
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Myalgic Encephalomyelitis
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Norway	Department of Oncology, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Fluge Ø, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28. doi: 10.1186/1471-2377-9-28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.	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.	Major response of at least six weeks duration, independent on when occuring, during the follow-up period.	Yes
Secondary	Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.	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)	At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention	Yes