RituxME is a multicentre study conducted in five study centres in Norway: the Oncology Department at Haukeland University Hospital, the ME/CFS Centre at Oslo University Hospital (Aker), the Dept of Medicine at Notodden Hospital, the Dept. of Pain and Complex Disorders at St. Olav's Hospital in Trondheim, and the Division of Rehabilitation Services at the University Hospital of North Norway in Tromsø.
The purpose of the study is to confirm or disprove the results from two smaller phase II studies, which have indicated improvement in symptoms in a subgroup of ME patients after rituximab treatment.
The study is randomized, double-blind and placebo controlled. This means that out of 152 participants, half will receive treatments with rituximab and the other half will be treated with placebo (saline). The treatments are allocated at random, and neither patient nor doctor is informed of which intervention group the patient is allocated to.
All participants receive six intravenous treatments during one year, followed by one year of regular consultations and blood tests. The participants complete examinations and tests before and after treatment, and they submit regular reports on any changes in symptoms and physical function.
The clinical study also encompasses three substudies:
- Endothelial function in ME/CFS – at Haukeland University Hospital and Notodden Hospital
- Ergospirometry in ME/CFS – at Haukeland University Hospital, Notodden Hospital and Oslo Universitety Hospital.
- Irritable Bowel Syndrome and functional dyspepsia in ME/CFS – at Haukeland University Hospital.
All 152 participants have been included in the trial and have commenced treatment. The study centres are no longer accepting applications for participation in the trial.
Each participant will receive follow-up for two years from start of their treatment. Both patient and doctor must remain unaware of the allocated treatment until the end of follow-up. Hence the study will be completed and the placebo and Rituximab treatment groups will be revealed two years after the last participant received his first treatment, i.e. late September 2017. We expect to publish the results of the study in 2018.