Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Conditions
Keywords
Chronic fatigue syndrome, CFS, Myalgic encephalomyelitis, Rituximab, B-cell depletion
Brief summary
Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that severely affected 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 chronic fatigue syndrome (CFS) patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms. An approved amendment (April 15th 2011): the study will be extended with up to 5 patients. For up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior to start of B-lymphocyte depletion using Rituximab (as in the protocol). Approved amendment (December 2011): 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.
Interventions
DRUGRituximab
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. For up to 5 patients in the study, standard plasma exchange (one plasma volume, up to 5 treatments, during 1-2 weeks) will be performed 2-3 weeks prior to start of Rituximab therapy. 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.
Sponsors
Haukeland University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
* patients severely affected by chronic fatigue syndrome, in WHO performance status III or IV. * 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 * 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 upper normal limit \[UNL\]) * reduced liver function (bilirubin or transaminases \> 1.5 x UNL) * HIV positivity * evidence of clinically significant infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Norway
Outcome results
None listed