HealingWell
Search Close Search
☰

Double Blind Remicade Study

Support Forums
>
Crohn's Disease
✚ New Topic ✚ Reply
❬ ❬ Previous Thread |Next Thread ❭ ❭
Posted 1/26/2012 3:52 PM (GMT 0)
So the hospital that I am in is a University and reserch hospital as well, they have approched me and asked if I would be interested in joining a double blind remicade after resection study....50-50 chance of actually getting remicade..plus the doctors taking care of me would not know which group I would land in.
You cannot take any other meds while in study and its for 4 years every 8 weeks.
It would involve a 3 and 1/2 hour drive just one way for the 4 hours I would be at the study centre...so an entireday that would be used...and as its a city I dont know I would need a driver.
My problem is that I am not ready to take the risk of being un-medicated for four years after the last few years of hell I have been through...plus then having to have emercency resection....I would rather go back to my humira and add 6mp to it. My husband and I talked it over and its really not something at this point that I feel comfortable doing.

What do you guys think? What would you do in this situation? If you did manage to get the drug in the study and it worked to keep you in remmision then after the study you would have to go through the steps to get your insurance or other funding to continue on it....
Posted 1/26/2012 4:00 PM (GMT 0)
Rhemicade, like Humira, is bio-based so you may build up resistance to it but it's worth a shot. Studies guarantee you the drug in the 2nd phase, and usually you get paid in addition to getting the medication free. One study drug I had put me into remission for 2 years, it worked wonders for me. However it got canned because it wasn't picking up in the FDA. It's a shame the regulations are so tight for drugs that work so well sometimes.
Posted 1/26/2012 4:06 PM (GMT 0)
Its a no pay study...they cover your parking and some travel expence...tbats it. They said no guarantee on getting drug at all...there are no phases...you either get it or dont get it.
Posted 1/26/2012 4:25 PM (GMT 0)
I have to say...on the off chance you don't get the meds...to be off all meds for 4 years is nuts and not smart.  Then what if you develop the anitbodies to Remi within the 4 years.  Are you alll of a sudden off the study.

I don't know just what they are trying to prove with the study but it seems weird and it isn't something I would do, especially right after surgery.  Be smart, stick to your meds and make your health the priority.

Posted 1/26/2012 4:57 PM (GMT 0)
Thats how I feel....yes study is done for you develope anti bodies....the point of the study is to see if remicade given after resection will keep a person in remmision and if so for how long....to me there isnt a point....I will go on meds my insurance and GI have already approved..not risk 4 year with nothing....
Posted 1/26/2012 7:38 PM (GMT 0)
No way would I commit to 4 years of possibly being med-free. Why are they even doing trials on Remicade still? It's been out around 10 years.
Posted 1/26/2012 8:15 PM (GMT 0)
I would NOT under that set of circumstances, myself anyways.
Posted 1/26/2012 9:22 PM (GMT 0)
I kind of see what they are getting after, but probably not the best way to conduct the study. I was given the option to not take meds after surgery. It wasn't recommended that I do that, but it was mentioned as an option. Perhaps they could appeal to patients who opt not to take anything and compare that group to those who take Remicade. Another alternative is that they could give people an infusion AND 6mp. Patients would get one of the drugs and one of the placebos for 4 years. Use that to measure efficiacy of each drug following surgery.

It's unfortunate that there are so many doctors and GI centers around and no one coordinates data. They could "easily" do a retrospective (or prospective) study of some sort. For example, let's say my doctor has 100 patients who have had surgery in the past 5 years. Some of them took med 1, some took med 2, some decided not to take any meds. How are the outcomes for each of those patient groups. Get just one doctor from every state in the US to participate in this kind of exercise and you have a large enough sample of patients to make the results statistically meaningful.
Posted 1/26/2012 10:35 PM (GMT 0)
Doesn't sound like a good idea. Yeah they'll cover SOME expenses but why would anyone travel that long, waste a day and have the off chance of not even getting the drug? & You having to be off al medication is kind of scary. I wouldn't do it. I'm with Javajay.
Posted 1/27/2012 12:32 AM (GMT 0)
Thats how I feel and I really thank you all for that support. I am on humira atm...well I will be starting again when my GI gives the all clear from healing...make sure chance of infection is gone and then restart my meds again.
✚ New Topic ✚ Reply