Status:
COMPLETED
B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
The Research Council of Norway
Norwegian Department of Health and Social Affairs
Conditions:
Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from B-lymphocyte treatment usin...
Detailed Description
We have published a case series of pilot patient observations with B-cell depletion in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) (Fluge and Mella, BMC Neurol, 2009). Subsequently, we p...
Eligibility Criteria
Inclusion
- Patients with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) according to Canadian diagnostic criteria (Carruthers, 2003)
- Duration of CFS/ME disease 2-15 years. For patients with mild CFS/ME duration of disease must be 5-15 years.
- Mild, Mild/Moderate, Moderate, Moderate/Severe and Severe CFS/ME may be included
- Signed informed consent
Exclusion
- Patients with fatigue, who do not comply with Canadian diagnostic criteria (2003)
- Duration of CFS/ME \< 2 years or \>15 years
- Patients with very severe CFS/ME
- Pregnancy or lactation.
- Previous malignant disease (except basal cell carcinoma in skin or uterine cervical dysplasia)
- Previous treatment with B-lymphocyte depleting therapeutic monoclonal antibodies, such as rituximab
- Previous long-term systemic immunosuppressive treatment, including drugs such as cyclosporine, azathioprine, mycophenolate mofetil, but except steroid treatment e.g. for obstructive lung disease or for other autoimmune diseases such as ulcerative colitis
- Severe endogenous depression
- Lack of ability to adhere to protocol
- Known multi-allergy with clinically assessed risk from rituximab infusion
- Reduced kidney function (serum creatinine \> 1,5x upper normal level)
- Reduced liver function (serum bilirubin or transaminases \> 1,5x upper normal level)
- Known HIV positivity, previous hepatitis B or hepatitis C
- Evidence of ongoing, active and clinically relevant infection
- Known immunodeficiency with risk from therapeutic B-cell depletion, such as hypogammaglobulinemia
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT02229942
Start Date
September 1 2014
End Date
November 1 2017
Last Update
May 11 2021
Active Locations (5)
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1
Dept. of Oncology, Haukeland University Hospital
Bergen, Norway, N-5021
2
Notodden Hospital
Notodden, Norway, N-3675
3
CFS/ME centre, Oslo University Hospital
Oslo, Norway, N-0424
4
Division of Rehabilitation Services, University Hospital of North Norway
Tromsø, Norway, N-9038