GOT PAPERWORK FOR NEW TRIAL DRUG MLN-0002 WHAT WOULD YOU DO?

wodin-I'm wondering the samething but I heard tysabri is sacreted throught the brain I don't know if remicade isn't. Remicade has been around for 10plus yrs and there have been no known cases of pml.

notsosicklygirl-I'm allergic to 5 asa's and 6mp-I was on antibiotics and they made no difference, I haven't tried mexotroxate she said and can use this and remicade but I'm not crazy about it.

 

I'm really happy with my gi, she is my second one. I hated the first one, he was a jerk, very mean, no sympathy. I will try humira before the trial drug. She even changed my diagnoses to chron's so my insurance would pay for it. I have to see rhemotology to get a somemore blood tests done to see if I'm lupus free. My gi did the two she can do and they came back negative but she said they can do alot more just to make sure. She just said if I have lupus than I can't go on any tnf blocker which is remicade, humira, etc. I don't think I have it but better safe than sorry.

She was open to me trying the humira and I do feel she is doing everything she can. She does ask the other gi's in her practice about my situation too. To see what they think. I'm just not crazy about doing the methotraxate with the remicade. It just makes me nervous.

WIMOMOFTHREE said...
I will try humira before the trial drug. She even changed my diagnoses to chron's so my insurance would pay for it.

Should people really be taking Humira for UC? It has some nasty side effects, such as serious infections and cancer:

http://www.humira.com/

There really is no need to be taking medications that can cause such side effects when UC can be cured with surgery. I really don't understand why someone would risk it. Enlighten me, please.

This is coming from someone who has worked on a (randomized double-blind) Phase III clinical trial.

Majority of the folks here have told you NOT to go with this trial drug for a variety of reasons. Let me be very frank, blunt and candid to you, they know heck about this drug. They are not the developers or the study administrators (Unless anyone really is). You mentioned about some another drug so they are making an effort to connect the dots. Agreed, they have concerns for your health but that doesn't really help. We see pharma industry as big devils but the scientists working their *** off in the lab are just like you and me. They are making genuine efforts. The money handling folks of the industry are the ones who act like devils.

Back to your point, your approach should be, to talk to the study administrator. Ask them hell lot of questions. Write down the questions and the answers if you want. The questions should be strong enough that will make the study administrator very uncomfortable answering them. Try to catch them in ethical boundaries. (In other words, don't let them play with the words when giving you the information.) Get the preliminary study material from them. At the time of administration of the study, every pharmaceutical company gives a "very fat" binder to the physician about how to administer the study, what are side effects and serious side effects expected. What effect should be considered as a serious side effect? etc. etc. Find out this information. Since it is randomized double blind study (if I understood correctly) you will either get placebo or the drug. A lot of things will be unknown and more will be a guesswork from previous studies performed. If this is not the case, its open label study and you will get the drug and then they have a lot more information than the double blind study.
Your physician gets paid for enrolling you and for you completing the study successfully or unsuccessfully. If you find your physician pushing you for enrolling in the trial, back off right away.

@ Eva Lou,
Principally, Remicade and Humira are same but Remicade is from mouse cell line and Humira is from Human cell line. Both are monocloncal antibodies and eventually both of them will stop working. Each and every individual will respond differently to these monoclonal antibodies, depending on their genetic make up. So please don't connect very distant dots. Talk to your GI before you decide to quit.

Hope my 2 cents help. Do drop us a line on what you decide and why. Good Luck.

deltaforce, you misunderstood my post. I'm well aware of what it is exactly that makes Remi & Humira different, the murine/human proteins. To call them two very distant dots is a stretch though- they are, after all, both tnf blockers. Plus, I have no intention to quit Humira. I stopped Remicade when it lost effectiveness for me. If & when Humira loses effectiveness, I'll stop that too.  

I was seriously considering it.  I understood the risks and knew the history. I did the golimumab study through 2009.   

eva lou-my gi said they closed the crohn's study to people who have been exposed to tnf blockers because they only take so many and they filled up.  I thought the samething. I'm still on remicade, I haven't been taken off of it.  I would have to even see if I qualify.

I see her the end of the month and I really don't feel comfortable with it. I'm going to tell her this.  I really don't think I'm going to do it. My sister in law said I would do it people say that because they aren't faced with it. You can say you are going to do something but when you have to do it and its your body it is alittle different.

i think you have made your decision, i think you made it a long time ago! and i think you want people to tell you its the right decsion, everyone wants that, its normal and a good thing toi get other peoples opinions, so imma tell you, its the right decision!