Rixtuximab Chronic Fatigue Syndrome (ME/CFS) Studies

Fluge & Mella – phase II – Under way

  • An open-label study
  • Aim: to test the impact of adding maintenance treatments of Rituximab (at 3, 6, 10 & 15 months) to their existing protocol. Fluge and Mella are hoping that regular infusions will allow patients to maintain their improvements (instead of relapsing). In an interview they reported they’ve been able to achieve this in some patients.
  • Follow-up period: 36 months
  •  n=30 (sample size)
  • Expected completion of data collection December 2013 (so publication would be unlikely before mid 2014)

http://clinicaltrials.gov/ct2/show/NCT01156909?term=kts-1-2008&rank=2

Fluge & Mella – phase II – Still recruiting

  • An open-label study
  • This small study differs from their other current Phase II trial in two key ways:
  • (i) The cohort for this trial is to consist of (only) severely ill ME/CFS patients
  • (ii) Up to half of the patients in this trial are to receive plasma exchange as well as Rituximab (see notes below on plasma exchange therapy**)
  •  n=10
  • Follow-up period: 36mths

http://clinicaltrials.gov/ct2/show/NCT01156922?term=NCT01156922&rank=1

Fluge & Mella – phase III – Not yet underway

  • The Norwegian ME Association reported this is to be a large randomized, double-blinded placebo-controlled study containing as many as 100-140 patients that meet the Canadian Consensus Criteria. The authors are working on the protocols now.  (Check out more here).
  • It is to be a multi-center study, conducted at several Norwegian university clinics.
  • The Norwegian government reportedly allocated two million Norwegian Kroners (approx. 220,000 USD) in funding. Much more money is needed.
  • This study will utilize the findings from their current (n=30) study. It’s final design will be influenced by those findings, and so it can’t commence until they have collected at least preliminary data from that current study. It’s been reported in Norway that the study may commence in summer.

Pathogenesis Study

  •  Fluge and Mella are digging into their now impressive biobank of samples and try to figure out just what is happening to ME/CFS patients as they improve on the drug.

Open Medicine Institute (OMI) Study

  • At the Invest in ME Conference Dr. Kogelnik announced the OMI will participate in or is participating in a trial. Patient reports suggest Kogelnik is working closely with Fluge/Mella to develop the trial, which will reportedly be six months long.  Dr. Peterson has indicated he will participate in the trial later this year.

PHANU (Griffiths University, Australia

  • Earlier in the year Dr. Marshall-Gradisnuk indicated that PHANU was interested in producing a trial.

(Etanercept (Enbrel))

  •  Etanercept is not Rituximab but it is an autoimmune drug. Fluge and Mella have received permission from the Norwegian government to give the tumor necrosis factor inhibitor Etanercept (Ebrel) to a set of patients who didn’t respond to Rituximab.

(The Phoenix Rising Forums provided most of the information for this page. Check out this thread for a good deal more….)

1 comment

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Maree Hibberd December 9, 2012 at 9:56 pm

I am very proud of every researcher working on this study. I have suffered from modertate to severe ME/CFS fro 20 years. It started when I was thirty. Bringing my very small family up in this weakened state has been incredibly hard and heart breaking. I was medically trained and loved my job but have not contribited towards the working world since my illness but have substantially contributed alot of money to many medical specalists,allied health workers and pharmacists over that time. So in effect I have keapt the economy chugging along. Many health proffesionals have been willing to help me but clearly lack either interest or knowledge in this area. I was fortunate enough to have found a doctor able to prescribe a drug to me which helps raise my cortisol levels. Without this drug I become very unwell and bed bound, whilst with it I can funtion sum what better but not to a normal level of health. I have to rest frequently due to the fatigue and migrane headaches. I also visit a neurologist who is trying his hardest with the headaches. I look forward to the future work being done by every Doctor involved and can be contacted if any person would like my past and present health profile.Thankyou to the team with all the very best from Maree.

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