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skewing the data

Posted: Fri May 21, 2010 12:47 pm
by k6ristin
in the beginning of my trial, I wanted 4-AP; so my docs checked w/ genzyme and i think the answer was, "it's not approved but not specifically forbidden, but promise not to take it a few days before the study visit/EDSS test." (even though 4AP only lasts 4 hours). "As to not skew the results."
Now I'm waiting for my Ampyra and haven't asked or heard any implications with study visits.
So, Yes, you agree in the beginning not to do anything without your study doctor's permission, (who asks the study monitor) who also should decide the best course of treatment for whatever you need or ask for.

Posted: Sat May 29, 2010 8:03 am
by ssmme
Okay, I've been meaning to post an update. My trial site called me Monday, May 10th at 4:30pm and told me the medical monitor considered it okay that I be treated. My trial site had received the blood test results. Genzymes numbers were 39 for the 8+ helper cells but the local blood test came back at 63. So with the medical monitors approval the local results were used. My trial site asked me to be there at 8am Tuesday morning. I didn't have much time to think about it so I did it. I am now 12 days post treatment and feel awful. Every ms symptom I have ever had in the past has reared it's ugly head and they seem worse than when I first had them. I am scared and very emotional right now.

How did you guys who have had the 2nd round do post-treatment? Were you really bad afterwards and then recover well? Did it take longer to recover? I need some reassurance here.


Posted: Sat May 29, 2010 8:18 am
by k6ristin
I'm sorry you're not feeling well. The same thing happened to me post 2nd treatment. Alot of MS symptoms seemed much worse, and it took about 3 months to level out, and feel "better"
I didn't keep as good record this year. If you have the energy, you might try reading all my posts, as I need to do, to refresh my own memory, as I am going on 3 months "late" for the 3rd infusion--it's optional.

It is a hot summer already in Florida and it's hard to say if I feel so bad right now because of a true MS "new" issue, or if it is the heat and stress of working and daily life that has me feeling bad.

Me, my husband, my neuro-nurse practitioner, and my neuro-doctor are talking amongst ourselves, the docs saying campath helped, my husband and I thinking more about the bad side effects. It's very hard to weigh the benefits and risks. I'm told there is a campath symposium coming up which should answer my questions on the new data from the study I'm enrolled in, and data from the older studies--remember ITP, kidneys, Fertility, Thyroid...

We live in an exciting time, if I weren't feeling so bad, to be excited, that potentially we can wipe out the immune system, fix our veins, and then look into stem cells. but this combo isn't quite available yet for everyone everywhere. Thanks for your personal update and I hope that good things come soon for you.

Posted: Sat May 29, 2010 10:08 am
by ssmme

What trial were you in? I'm in Care-MS II. I really want to look into CCSVI especially since I feel so crappy right now.

Do you only get the third dosing if you show exacerbations or disease progression? That's how my trial is.


Posted: Mon Jun 28, 2010 3:07 pm
by offlabelgirl
Hi guys:
I just did Campath off-label and found your forum to be SOOOO helpful. Thanks a lot! When I was itching like crazy (I developed a really bad rash to Campath for 4 days of infusion PLUS 2 days after) I was reading your stories for inspiration. I think this forum is great and it is so great to read all the stories, I feel like it’s the best support group for us as non-MSrs don’t understand what we are going through and most MSrs I’ve encountered were not too eager to share. In addition, I could not find anyone who had Campath either as part of the study or off-label.
I have a very mild course of the disease. I was diagnosed in July of 1999 while having a major optic neuritis. Since I only had 4 more mild-to-major flare ups over the years I was not treated. That all changed this January after I gave birth to my 3d child. I had a major flare-up post-partum where I became week on my right side and could not walk or lift my arm or fingers (thank god for Solumedrol). That’s when I convinced my neurologist to do Campath off-label (he did previously suggest that I join the study but I was in the process of expanding my family, a no-no for Campath).
My neuro did not administer Campath himself. He found a hematologist/oncologist who took me on. Now I have 2 very curious MDs monitoring me. As I said, I am very fresh off Campath (I just finished my last infusion on 6/25/10) but am extremely excited and optimistic after reading your posts.

Posted: Mon Jun 28, 2010 5:31 pm
by k6ristin
you're very welcome. I also find much comfort here.
Remember to take it with a grain of salt :)
Now share your story for us as it unfolds!

Does campath really cost $18,000 and/or did your insurance pay?

Thanks for commenting and I wish you all the best!

Posted: Tue Jun 29, 2010 5:18 am
by offlabelgirl
I think my insurance will pay :D Not sure yet as I did not receive my EOB yet :D My MD was getting the approval and when I called my insurance they seemed to be "on-board." Btw, I live in NJ and we have a codified statute that the insurance companies MUST pay for an off-label treatment as long as prescribed by an MD and is medically necessary. I'll update you on the cost once I find out.

Posted: Tue Jun 29, 2010 5:07 pm
by patientx
Hi Offlabelgirl:

I was wondering: are your doctors monitoring you like in the trial protocol, i.e. monthly blood draws to check for ITP?

Posted: Wed Jun 30, 2010 5:24 am
by offlabelgirl
I am hoping so :D My hem/onc who administered Campath is monitoring the blood work for now. He is the one that prescribed the antibiotics to go with the treatment and he will be the one taking me off them. I think he will be monitoring my blood until the second treatment (god willing I will be able to get it) but my neuro is monitoring the MS progression or, hopefully, lack thereof. Both are following the CARE-MS II study protocol, but I am keeping taps on both :D I have my first post-Campath set of labs on 7/6, so I'll see what happens. They did tell me, though, if I will have any Graves disease indicators they will get an endocrinologist involved. I guess I will have a whole "team" of doctors dealing with one off-label me :D


Posted: Sat Jul 31, 2010 6:41 am
by k6ristin
I had positive TPO antibodies in the beginning (2008) and haven't had any thyroid issues.......yet :)