I am going to be a lab rat

[Aliantha]

As most of you may know, I suffer (yes, I do mean suffer, not live with or any other fancy pants new age term) from psoriasis. Today I went to see a new dermatologist and he's offered me the chance to participate in a new drug trial.

Here are the details:

You are being invited to participate in a research study, which is being conducted in order to find out if the investigational drug, brodalumab, is a safe and effective treatment in people with moderate to severe plaque psoriasis and whether it causes any side effects. This study will also
Protocol No.: 20120103
A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of
Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque
Psoriasis: AMAGINE-2
Version 3.0: 5 July 2012 Page 2 of 17
Amgen Version: 3
test what happens when you change the dose (strength) or how frequently you are taking brodalumab.
To do this, brodalumab will be compared to ustekinumab (a drug used to treat psoriasis) and to placebo. Ustekinumab is a drug which has been approved by regulatory health agencies, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Therapeutic Goods Administration (TGA) for the treatment of moderate to severe plaque psoriasis.. Ustekinumab is sold in the United States, European Union and Australia under the name “Stelara”. The placebo used in this study will look like brodalumab and ustekinumab, but will not contain any active ingredients. Taking placebo is the same as not taking anything for your psoriasis. You are being asked to participate in this study because you have moderate to severe plaque psoriasis.

It's a five year trial, so if the drug works as well as the doc has said, then I will at least have 5 years of peace. Not sure what I will do after the trial. The drug will cost about $20k/yr after that. For now, it'll be free.

[Lamplighter]

Of course, you could end up in the placebo group.

Since I doubt there is a "placebo effect" to be had with psoriasis,
that would not be very appealing.

[Aliantha]

The placebo group only goes for 12 weeks, then they give you the real drug anyway. It's all there among the other 17 pages of info.

[Aliantha]

After the first 12 weeks, i'll have to do my own injections, or have someone in the family taught. I think I'll just learn how to do it myself. It can't be that hard. Plenty of people inject themselves all the time.

[xoxoxoBruce]

Sure, just mix it in with your heroin.

I hope this proves to be a true miracle drug, and if it works as well as your doctor says, the price drops dramatically.

[Aliantha]

Time will tell Bruce. I intend to take before and after photos for myself. They will be taking them too of course, but I doubt I'll have access to them till after the trial is completed.

The doc told me not to get my hopes up because there is the chance that for some reason it wont work for me (it is still in trial after all) but he said, "it's like seeing a great movie and rating it 12 out of 10, cause it's just that great". Hard not to get your hopes up when someone tells you that.

If I can get rid of this hideous, most insidious disorder it will make such a difference to my quality of life. Dana would probably understand. Anyway, it's just so hard to live with. It itches and it stings and it aches and it causes arthritis, so joints are painful. I have blood on my clothing because the skin breaks open if I bump against something. It's just horrible.

I think I'd do this trial even if they said it might take ten years off my life, because to be honest with you, there are times when it gets me down so badly that I have to really work to pull myself back up again.

[Aliantha]

So, this morning i am going to have all the blood tests and stuff required for the screening process. I feel nervous now that i might not qualify or they'll find i have some terrible disease that has been lurking unnoticed. :/

[Ocean's Edge]

keeping my finger crossed for you

[xoxoxoBruce]

Good luck.

[orthodoc]

Good luck, Ali! I hope it helps.

[Aliantha]

It all went pretty well. It must be that you have really badly 'fail' your blood tests in order not to be considered because they've done all the other stuff, and given me the electronic diary to do every night. I get my first injection next monday after 7 days of the diary. They have to do a TB test next week also. I expect that will come up negative since I was immunised when I was a teenager.

Now I'm just hoping I'm in the group that gets the drug right from the start!

[Lamplighter]

<snip>since I was immunised when I was a teenager.

That seems very unusual... maybe your were skin tested , instead ?

(BCG nullifies the usefulness of the TB skin test,
because it converts the person's response to positive.)

But then too, maybe you were living in a very unusual environment.

[ZenGum]

Getting a TB shot in high school is the norm here. I specifically avoided it because the immunity often doesn't last.

[Aliantha]

Yeah, I think there was a TB scare in the area or something, so we all got tested, and some of us were immunised. It was pretty common back then. Not so much now.

[orthodoc]

Be sure to let them know next week that you've had BCG. As Lamplighter says, it renders later TB skin tests useless because they always come up positive.