Aa
MEDI-551
I received information yesterday on participating in the trial for MEDI-551. I'm still trying to read through the information, and process it all, but it looks promising.
Has anyone else done any investigation into this??
Has anyone else done any investigation into this??
There's not much more I can add - I know my neuro will not put his patients in a study that involves a placebo arm, feeling that we all need to be on some sort of treatment and not just sugar pills.
I do want to say thank you to everyone who participates in these studies - we can't move forward without these clinical trials and those don't happen without selfless volunteers. It is a lot to consider and only you can decide if it is worth it or not.
best,
Laura
I do want to say thank you to everyone who participates in these studies - we can't move forward without these clinical trials and those don't happen without selfless volunteers. It is a lot to consider and only you can decide if it is worth it or not.
best,
Laura
Thank you for pointing me in the right direction, Ren. I think I got there in the end. http://clinicaltrials.gov/ct2/show/NCT01585766 Though please correct me if that's not it, Cuttersmom! The looooooong post can be ignored pretty much if I found the wrong one!
I'm also on a clinical trial involving monoclonal antibodies (anything that ends with a -mab in its name is one of those). They seem to be a really vibrant area of interest for MS medication.
Tysabri (Natalizumab), to my knowledge, is the only one that's currently available 'on-label' (meaning it's explicitly approved for use in MS patients) with many more in various stages of testing or the approval process.
Certain words found in the link I posted above are 'watch words' I would demand to see in any drug trial I might participate in.
'Double blind' is one. This means neither you nor the people who will be monitoring you will know if you're on the drug or a placebo. This is imperative when it comes to generating worthwhile data.
'Randomised' means it is completely a coin toss which group you go into. This is also a hallmark or a properly conducted study. So this looks like a standard, legit, well conducted clinical trial.
There are a couple of reasons why this particular trial would not have been right for me personally when I was deciding to participate in one myself. It's a phase I, meaning they don't have a lot of safety or efficacy data yet. Drugs usually go through three phases of trial plus and extension from first-in-man to pilot study to FDA approval. The process can easily take about 7-10+ years.
This isn't necessarily a bad thing. It's a necessary step in getting new drugs out there, but as I'd not been on any DMDs ever at the time, I wanted something with a bit more data I could wade through.
Second; it's drug versus placebo. I was not prepared to be on nothing at all. Companies that own a standard treatment already in use will typically randomise between the drug being tested and the one already on the market as there are ethical issues with withholding standard-of-care treatments if you (the company) have them. Looking at the site for the company running this trial, it looks like they don't currently have any MS drugs on the market themselves. Though this is going on the information I found. I could be mistaken.
So while the reality I faced was 'you'll be on a trial drug or be on Avonex', this would be 'be on a trial drug with little data yet or be on nothing'. I wasn't willing to go for that option myself, but this is a VERY personal choice and each and every one of us on DMDs have benefited from people making just that choice.
If I did manage to link to the relevant study, it states they'll have their primary data by June next year, though it may go into an extension. This is my third criterion it wouldn't have met. I wanted a little time-frame security. I knew from day one I'd be on the trial for 144 weeks with a likely 144-week extension. Barring a serious adverse event that brings a halt to the trial or my participation in it, that was a minimum c. three years and likely 5.5 years I was able to kick back knowing this was my treatment.
There's a lot to think about when deciding for a trial after all the screening process has been taken care of and before that 20-something page document gets signed. For me it's been a very positive experience. I feel very lucky and well looked after.
Specifics to consider:
Think about what aspects of a trial you can live with and what you can't. What are your priorities? There will almost certainly be a protocol for you to come into the trial site. How often? Will this interfere with work? Or be inconvenient transport-wise or time-wise? Will you be dealing with new doctors or ones you're already familiar with?
I'm on a course that is very accommodating to medical appointments and I can actually walk to the hospital from my home. If these things were vastly different, it may not have appealed to me so much. Will the trial reimburse you for transport costs? (If I didn't walk, mine would reimburse up to €50 per visit).
It's a lot to think about, isn't it?! Being on a trial can be exciting, informative, and a great short-ish term solution for those with insurance or other financial issues as the cost of the drugs are covered. But it also takes a bit of commitment (On-going appointments and likely a little diary to fill out.) and a bit of a leap of faith.
I realise I've just written the War and Peace of responses, but it's an area I can actually discuss with some authority so I just went for it! I do apologise if I got a bit broad in my interpretation of your original question. (and especially if I didn't even pick the right trial to respond to!)
I'm also on a clinical trial involving monoclonal antibodies (anything that ends with a -mab in its name is one of those). They seem to be a really vibrant area of interest for MS medication.
Tysabri (Natalizumab), to my knowledge, is the only one that's currently available 'on-label' (meaning it's explicitly approved for use in MS patients) with many more in various stages of testing or the approval process.
Certain words found in the link I posted above are 'watch words' I would demand to see in any drug trial I might participate in.
'Double blind' is one. This means neither you nor the people who will be monitoring you will know if you're on the drug or a placebo. This is imperative when it comes to generating worthwhile data.
'Randomised' means it is completely a coin toss which group you go into. This is also a hallmark or a properly conducted study. So this looks like a standard, legit, well conducted clinical trial.
There are a couple of reasons why this particular trial would not have been right for me personally when I was deciding to participate in one myself. It's a phase I, meaning they don't have a lot of safety or efficacy data yet. Drugs usually go through three phases of trial plus and extension from first-in-man to pilot study to FDA approval. The process can easily take about 7-10+ years.
This isn't necessarily a bad thing. It's a necessary step in getting new drugs out there, but as I'd not been on any DMDs ever at the time, I wanted something with a bit more data I could wade through.
Second; it's drug versus placebo. I was not prepared to be on nothing at all. Companies that own a standard treatment already in use will typically randomise between the drug being tested and the one already on the market as there are ethical issues with withholding standard-of-care treatments if you (the company) have them. Looking at the site for the company running this trial, it looks like they don't currently have any MS drugs on the market themselves. Though this is going on the information I found. I could be mistaken.
So while the reality I faced was 'you'll be on a trial drug or be on Avonex', this would be 'be on a trial drug with little data yet or be on nothing'. I wasn't willing to go for that option myself, but this is a VERY personal choice and each and every one of us on DMDs have benefited from people making just that choice.
If I did manage to link to the relevant study, it states they'll have their primary data by June next year, though it may go into an extension. This is my third criterion it wouldn't have met. I wanted a little time-frame security. I knew from day one I'd be on the trial for 144 weeks with a likely 144-week extension. Barring a serious adverse event that brings a halt to the trial or my participation in it, that was a minimum c. three years and likely 5.5 years I was able to kick back knowing this was my treatment.
There's a lot to think about when deciding for a trial after all the screening process has been taken care of and before that 20-something page document gets signed. For me it's been a very positive experience. I feel very lucky and well looked after.
Specifics to consider:
Think about what aspects of a trial you can live with and what you can't. What are your priorities? There will almost certainly be a protocol for you to come into the trial site. How often? Will this interfere with work? Or be inconvenient transport-wise or time-wise? Will you be dealing with new doctors or ones you're already familiar with?
I'm on a course that is very accommodating to medical appointments and I can actually walk to the hospital from my home. If these things were vastly different, it may not have appealed to me so much. Will the trial reimburse you for transport costs? (If I didn't walk, mine would reimburse up to €50 per visit).
It's a lot to think about, isn't it?! Being on a trial can be exciting, informative, and a great short-ish term solution for those with insurance or other financial issues as the cost of the drugs are covered. But it also takes a bit of commitment (On-going appointments and likely a little diary to fill out.) and a bit of a leap of faith.
I realise I've just written the War and Peace of responses, but it's an area I can actually discuss with some authority so I just went for it! I do apologise if I got a bit broad in my interpretation of your original question. (and especially if I didn't even pick the right trial to respond to!)
I searched PubMed and found references to MEDI-551. It is an monoclonal antibody similar to Tsyabri or Rituxan. The link to the review I found is in medical jargon but here it is:
http://www.ncbi.nlm.nih.gov/pubmed/23448220
If you decide to do this trial, please keep us updated. I would be interesed in knowing how things go.
What type of MS are you diagnosed with? RRMS, SPMS PPMS?
Good luck,
Ren
http://www.ncbi.nlm.nih.gov/pubmed/23448220
If you decide to do this trial, please keep us updated. I would be interesed in knowing how things go.
What type of MS are you diagnosed with? RRMS, SPMS PPMS?
Good luck,
Ren
Could you share a little more? My googling (admittedly done late at night!) only turns up phase II open-label trials for things other than MS.
Does it have a trial 'nickname' perhaps? They often have one word nicknames for ease of reference without numbers, etc. Things like 'DECIDE', 'SELECT', 'CHOICE', etc.
Does it have a trial 'nickname' perhaps? They often have one word nicknames for ease of reference without numbers, etc. Things like 'DECIDE', 'SELECT', 'CHOICE', etc.
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