This Is MS Multiple Sclerosis Community: Knowledge & Support

I just got back from my pre-trial screening. The site I am looking at is in the final stages of hopefully getting approved. I should know by next Monday latest. A lot of things concerned me about the site and trial. I would be the 1st participant at this site. That means possibly not as much experience with Campath as a site that has given many already. Otherwise the site seemed fine. There is a hospital on the campus, an infusion center, the principal investigator / neurologist has his office there and it is only about 1.5-2 hour drive from my house. There is another site at USC, but that is farther and would be much less convenient.

Then the trial itself.... the informed consent form took > 2hours to go through. I was unaware of the high rate of pretty grim side effects. 6 of 216 patients got ITP which is pretty darn serious and requires much steriods and possibly blood platelet infusions. Then the thyroid issue...>25% of patients have thyroid issues and some can get some phenomenon where the eyes swell and bulge too. That does not go away even after the treatment for that side effect's cause. The doctor kept reminding me that this trial had a pretty high rate of serious side effects.

Well damn...now I am back to waffling on it. The side effects listed were ominous at best. The doctor's at this site have not administered Campath before (they do have close contacts with USC where many patients are in the trial already). I am going to read through the consent form again as I will not know for a few days if this site is going to be accepted. The principle investigator doctor and the regulatory affairs Dr both said that I meet the criterea for inclusion, a perfect candidate they said - so that is out of the way. Now I just have to figure out what the hay to do. Tysabri does not sound so bad anymore... argghh I am flippin out. Any comments are welcome.

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Grump:

Both my sister-in-law and brother-in-law have to take thyroid medication every day. I would definitely trade my daily shot for a daily pill.

ITP is a pretty serious condition. But, from what I've read, almost all of the people who developed it were successfully treated with steroids. The trial protocol calls for monthly blood draws for 3 years, so if this does become a problem, they should be able to catch it early.

If you do enroll and are the first person treated at this site, just think, you'll be a pioneer.

Grumpster,
The thyroid condition is treatable, but it does require daily medication. As mentioned in previous post, your blood is tested every single month, and you see your doctor every 3 months(every month for the first 3 months post infusion)
so signs of ITP are checked for every month & thyroid every 3months.
You mentioned the treatment center is 1-2 hours away? This could be a hassle for you! I understand the desperation to find treatment at any cost, but being in the study is a very very involved process.
My study site, along with genzyme, have coordinated with a home health company that comes to my home/job every month for the blood draw, so this saves on time & energy going to the doctors.
But, as I've posted, I was often sick with respiratory infections for the first 9 months after infusion...So i was always stopping by their office to get checked out, chest xrays, and scripts for antibiotics. IF you had these problems, the study site would be responsible for taking care of you with all these related problems...but because it's so far away you might end up seeing a local doctor...but then you'd have to pay for it!!!

My neuro doc continues to be very positive about the results he's seeing and reading. He tells me of new scary side effects (most recently a death involving a blood clot) but reassures that these things would be detected as long as I'm reporting everything I'm feeling. Which I do, via email whenever I feel like it. So a good relationship with your study site is really important. I trust my team & so far they haven't let me down.

It's a huge decision, I know how you feel! Also, after all your deliberations and paperwork and pre-infusion tests, you could be randomized to the Rebif arm!!! (of course at that point you could refuse, or get free rebif for a few years)

Keep up the good fight!!