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 was to confirm or disprove the results from two smaller phase II studies, which indicated improvement in symptoms in a subgroup of ME patients after rituximab treatment.
The study was randomized, double-blind and placebo controlled. This means that out of 151 participants, half received treatments with rituximab and the other half with placebo (saline). The treatments were allocated at random, and neither patient nor doctor were informed of which intervention group the patients were allocated to, until follow-up for the last patient was completed.
The participants received six intravenous treatments during one year, followed by one year of regular consultations and blood tests. The participants completed examinations and tests before and after treatment, and they submitted 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 patient treatment and follow-up were completed according to schedule in September 2017. The placebo and rituximab groups were revealed to the scientists in October, and all participants were informed. The results have been published in Annals of Internal Medicine; please refer to the links section below for a link to the research article (limited access) and a summary of the results by the research team on the Kavli Trust website. We are presently working on further analyses and comprehensive laboratory studies based on biobank samples and clinical data from the trial and substudies.