Inclusion Criteria:
- 18 Years to 55 years
- Confirmed RRMS according to revised 2010 McDonald criteria and MRI brain lesions consistent with MS
- At least 2 documented relapses within the past 3 years prior to screening or at least one documented relapse within 1 year prior to screening
- EDSS between 0.0 and 5.0 at screening
- Subjects in the phase 1 part should have at least 1 but not more than 15 gadolinium-enhancing lesion(s) by cranial MRI at screening
- Subjects participating in the phase 2 part can have 0-15 gadolinium-enhancing lesion(s)
Exclusion Criteria:
- Subjects with impaired renal function
- Major surgery within 8 weeks of the screening visit
- Subjects who are unable to undergo cranial MRI scan
- A history of hypersensitivity to Gd-containing MRI contrast agents
- A history of hypersensitivity to natural or recombinant interferon beta (Phase 2)
- Has received at any time monoclonal antibodies or experimental B-cell depleting agents
- Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification for RRMS
- Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug
- Diagnosis of a non-RRMS neuro-inflammatory or demyelinating disease
- Any history of opportunistic infection or the presence of active infection within two months prior to screening or any herpes zoster infection that has not resolved within 12 weeks prior to screening
- Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol
“For those of you interested in biology: the reason why I think anti-CD19 may prove to superior to anti-CD20 treatment (rituximab, ocrelizumab, ofatumumab) is that it targets plasmablasts and possibly plasma cells; the picture below shows you the B-cell lineage and the expression patterns of both CD20 and CD19. Plasmablasts and plasma cells are the factory cells that make large amounts of antibody. There is a lot of data linking these cells to MS. Therefore if we can kill or suppress these cells we may have additional benefits. The good news for MSers is that this is another novel treatment that is being tested in MS and is likely to be a very efficacious agent.”
CoI: I am the principal investigator of the MEDI-551 trial at Barts Health and MS@UCLP and I sit on the steering committee that designed, and will help, run the trial.
Sounds interesting Prof G.According to the clinicaltrials.gov site, this is due to complete in terms of data in 2015 and then results be available in 2016. It appears to be a 1 year total study. Why won't data be available in early 2014 therefore and why does it take 1 year from final collection of data to reporting it? Surely a bright statistician could intepret the data over a weekend?!
It all depends on how long it takes to recruit!
I see. I would have thought people would be fighting to get into a trial such as this but I guess not. That doesn't explain the year delay from final data collection to reporting the data though? These trials are all FAR too long. Smaller numbers of people per study (which might need greater positive results to achieve significance but, frankly, that should be the goal anyway); quicker ways of judging their success (perhaps along the lines of your neurofilament work); more MRI surrogates for relapse/progression and, finally, quicker reporting of results. The whole trial system is a beaureacratic mess it seems to me which means, as you've pointed out many times, if a new wonder drug,a potential total cure for MS, were discovered today – it could be 15 years before it was commercially available. That is insane and the true scandal of where MSer are being let down, not by pharma etc… I know from your slides from your talk the other day this is an area of interest to you but what is being done to improve this situation and, if anything, by whom?
Do you think anti-CD20 treatment (rituximab, ocrelizumab, altumumab) will then fail to make a difference to progressive MSers?It's when I read posts like this one realises how mismanaged MS treatment is. So much money will be wasted on anti-CD20 when anti-CD19 may be better.Nice to see such an interesting approach restricted to RRMSers only. It's like the richest people getting a tax-break whilst the rest of us continue to get hammered.
It is impossibly difficult to do phase 2 trials in progressive MS; very poor and unresponsive outcomes, which is why we are doing the CSF neurofilament study. In RRMS you use the MRI as a readout. I am sure of the RRMS trials are positive then a progressive trial will be on the cards. For example, Roche are running three ocrelizumab trials in parallel; two relapsing and one PPMS.