B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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 using the monoclonal anti-CD20 antibody rituximab with induction and maintenance treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Collaborators: MEandYou Foundation; Norwegian Department of Health and Social Affairs; Oslo University Hospital; St. Olavs Hospital; Sykehuset Telemark; The Kavli Foundation; The Norwegian ME association; The Research Council of Norway; Trondheim University Hospital; University Hospital of North Norway
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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