Anyone participating in the Janssen Biotech study?

[izzi'smom]

We received some info on it yesterday and will probably participate. It's a twenty year paid registry of peds patients with IBD sponsored by Janssen Biotech (maker of Remicade).
The only thing I *don't* like about it is that you aren't "allowed" to participate in any studies involving drugs not already FDA approved. (WOndering if this is because it is potential competition or to not skew the study with drugs that there isn't already data on, as you *can* participate in studies involving drugs that *are* FDA approved).
Anyone else?

 

[Brian'sMom]

Isn't Remicade the only biologic FDA approved for pediatrics? Our GI doc said at our last visit that Humira will at some point be approved for children. Right now its only allowed if Remicade doesn't work.

 

[tiloah]

Well if she ever needs to be on a drug that's not FDA approved, you could always just drop the study right? Although it does seem like a kind of rude requirement. Sounds "fun" though.

 

[izzi'smom]

Kathy...I don't know, as I haven't been able to research yet. I'm sure the insurance company will let me know when they reject us for this reason lol! I have called the admin to ask that question, Nic...waiting to hear back. Who KNOWS what we may try in the future...I can't say that for certainty right now, KWIM?

 

[Johnnysmom]

Is the restriction FDA approved or FDA approved for crohn's? I think LDN is not FDA approved for crohn's disease.

 

[Dexky]

Isn't Remicade the only biologic FDA approved for pediatrics? Our GI doc said at our last visit that Humira will at some point be approved for children. Right now its only allowed if Remicade doesn't work.

EJ went straight to Humira. There was no discussion about it not being approved for peds. Hmmm?

We haven't received any info about the trial though Angie.

 

[izzi'smom]

it says FDA approved...I <3 loopholes! lol

 

[Brian'sMom]

EJ went straight to Humira. There was no discussion about it not being approved for peds. Hmmm?

Maybe it's already done, that's good! I know it was in process when we were struggling a year ago. We didn't have any trouble going to Humira, just had to go down the 'Remicade failing' road first.