Back to resultsB-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
Primary Purpose
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic fatigue syndrome, CFS, Myalgic encephalomyelitis, Rituximab, B-cell depletion
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
Sites / Locations
- Department of Oncology, Haukeland University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01156909
First Posted
July 2, 2010
Last Updated
August 29, 2014
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01156909
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Keywords
Chronic fatigue syndrome, CFS, Myalgic encephalomyelitis, Rituximab, B-cell depletion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
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 Outcome Measure Information:
Title
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Description
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.
Time Frame
Major response of at least six weeks duration, independent on when occuring, during the follow-up period.
Secondary Outcome Measure Information:
Title
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
Description
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)
Time Frame
At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Mella, PhD, MD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
19566965
Citation
Fluge O, 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.
Results Reference
background
PubMed Identifier
26132314
Citation
Fluge O, Risa K, Lunde S, Alme K, Rekeland IG, Sapkota D, Kristoffersen EK, Sorland K, Bruland O, Dahl O, Mella O. B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment. PLoS One. 2015 Jul 1;10(7):e0129898. doi: 10.1371/journal.pone.0129898. eCollection 2015.
Results Reference
derived
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B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
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