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Research // Taking part in research // Bimagrumab Clinical Trial in Inclusion Body Myositis (IBM)

Update 1st October 2014
Phase IIb/III Bimafrumab Study has started
Patients at the three study centres are now in the Novartis phase IIb/III bimagrumab study. This trial was described to IBM members at our conference in July. This is a clinical trial for a drug that may have therapeutic benefit in IBM, the purpose of the study is to further develop an understanding of it's safety, side effects and if improvement/stablilisation of symptoms does occur. Bimagrumab will require further study if positive data is obtained from the trial. The trial is happening at centres across the world to gain enough data from enough patients with IBM to draw a scientific conclusion. Recruitment to the trial has been completed although not all patients have yet started on the study. The three centres, London (UCL - Queens' Square), Newcastle (Newcastle Upon Tyne University Hospital NHS Foundation Trust, Clinical Aging Research Unit (CARU)) and Manchester (Salford Royal Hospital) are actively involved in research and if you are seen here they would of already recorded your preference to be involved in clinical trials. If you were suitable, there were strict criteria set out by the trial organisers, you would of been contacted by your doctor. If you are not seen at these centres but would like to be considered for future trials please discuss this with your doctor or contact Dr Pedro Machado at Queen's Square UCL for information.

Update 30th June 2014
Statement from Novartis
"Following a robust feasibility and clinical trial site selection process the following sites have been selected (pending local R&D approvals) to take part in the Phase IIb/III bimagrumab study:
Newcastle (Newcastle Upon Tyne University Hospital NHS Foundation Trust, Clinical Aging Research Unit (CARU))
Manchester (Salford Royal Hospital)
London (UCL - Queens' Square)
Unfortunately, Novartis cannot comment on the individual situation with Southampton University Hospital."

Update 26th June 2014
Myositis UK are disappointed to hear that the Muscle Unit at Southampton will now not be one of the proposed centres for the clinical trial. This leaves 3 centres in the UK, one being Queens Square UCL in London. It was hoped Southampton would be a centre for the clinical trial as if offered a location in the south and outside of London. Dr Hammans and his team who were at the advanced stage of organisation for Southampton to be a centre recruiting onto the Bimagrumab trial have written to their patients informing them of this. Myositis UK have contacted Novartis for a statement as the charity has received enquiries from Southampton patients (willing to be considered for the clinical trial) for more clarification as the alternative, travelling to London, is not a suitable alternative for them.

Update 12th June 2014
Results of one of the Phase 2 trials have been published on the Novartis website. To view you need tovisit their website,agree to the terms and then scroll down and click on Myositis to access the PDF.

The pharmaceutical company Novartis have a new drug that may be of benefit in the treatment of IBM. Before it can be used routinely new drugs have to undergo a set of clinical trials.

Bimagrumab has been shown to be safe for use in a phase 1 trial (conducted in the USA) and is now entering a phase 2 trial (global) where the efficacy, safety and tolerability of multiple doses of Bimagrumab will be further studied.

This is a global study recruiting 240 patients and the UK is hoped to have four centres involved including Queens Square London.

Myositis UK have met with Novartis who presented the treatment and why it may be of benefit in IBM. At this point the charity is unable to publish further details, at the request of Novartis, except to say at the meeting for ethics approval some questions were raised that need to be addressed although more information should be with us in the next few months.

Some of the details have been listed on the Clinical Trials website which has information on inclusion and exclusion criteria.

Novartis are pleased to hear that there is great interest for the study from Myositis UK members and they look forward to updating everyone soon.

What is the new drug?
Bimagrumab/BYM338.
Awaiting further details.

Why may it be of benefit in IBM?
Waiting update

Can I participate?
Unfortunately, clinical trials have inclusion and exclusion criteria for many reasons, mostly to make the trial as robust as possible. Details of the UK arm have not yet been disclosed but the criteria can be found on the clinical trials website. Four centres in the UK are being considered to allow accessibility for more patients.

If you are interested in being part of a clinical trial please discuss this with your doctor who will be able to contact the trial organizer and discuss your participation.

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