Following the news of the null result of the Norwegian Phase III trial, and interest in how this impacts the planned UK trial, I thought it might be useful to open a thread for this.
The microsite for this UK rituximab trial and associated B-cell research is on Invest in ME Research Centre of Excellence website, so anyone wanting to know the background may follow the links here: http://www.investinme.org/ukrtbcell-ce-index.shtml
The plan was for the Haukeland team to visit the UK team again before the end of this year, once the codes for the Phase III trial had been broken in October, and following from their visit to Norwich in January (which included public talks) to discuss a UK trial to begin in 2018.
It's been reported that announcement of the null result was made early for the sake of patients, as particpants receiving placebo had been promised attempts to include them in a new trial if rituximab had proved effective, so it wouldn't be fair to keep them in false hope for months until publication; and they wanted to avoid patients going for treatment outside of clinical trials and with unselected patients, which they have always advised against.
Likewise, one of the reasons for delay in starting a UK trial is because the preceding B-cell research, as advised by Jonathan Edwards and led by Jo Cambridge at UCL, was aimed at being able to identify a subset of likely responders to rituximab in the ME/CFS patient group, while being useful research in its own right, so this work has proceeded with great care and caution to the credit of all the researchers involved.
So, at the time of writing, the B-cell research is ongoing, and Invest in ME Research stated that they hope (as originally planned) to meet with the researchers soon. This was their initial statement in response to the news from Norway of a null result:
http://www.investinme.org/IIMER-Newslet-1711-03.shtml
EDITED 12th February 2018 to add statement by Invest in ME Research: http://www.investinme.org/IIMER-Newslet-1802-01.shtml
(in short, they will not be going ahead with a UK trial of rituximab).
The microsite for this UK rituximab trial and associated B-cell research is on Invest in ME Research Centre of Excellence website, so anyone wanting to know the background may follow the links here: http://www.investinme.org/ukrtbcell-ce-index.shtml
The plan was for the Haukeland team to visit the UK team again before the end of this year, once the codes for the Phase III trial had been broken in October, and following from their visit to Norwich in January (which included public talks) to discuss a UK trial to begin in 2018.
It's been reported that announcement of the null result was made early for the sake of patients, as particpants receiving placebo had been promised attempts to include them in a new trial if rituximab had proved effective, so it wouldn't be fair to keep them in false hope for months until publication; and they wanted to avoid patients going for treatment outside of clinical trials and with unselected patients, which they have always advised against.
Likewise, one of the reasons for delay in starting a UK trial is because the preceding B-cell research, as advised by Jonathan Edwards and led by Jo Cambridge at UCL, was aimed at being able to identify a subset of likely responders to rituximab in the ME/CFS patient group, while being useful research in its own right, so this work has proceeded with great care and caution to the credit of all the researchers involved.
So, at the time of writing, the B-cell research is ongoing, and Invest in ME Research stated that they hope (as originally planned) to meet with the researchers soon. This was their initial statement in response to the news from Norway of a null result:
http://www.investinme.org/IIMER-Newslet-1711-03.shtml
EDITED 12th February 2018 to add statement by Invest in ME Research: http://www.investinme.org/IIMER-Newslet-1802-01.shtml
(in short, they will not be going ahead with a UK trial of rituximab).
Last edited:
