Re: Humira trial

April 9, 2008

Beth, I'm an Enbrel girl, but I would totally go for the study. Humira is well

studied and has a similar safety profile to Enbrel. Sounds like they're

checking out the efficacy on a different dosing schedule. You could contribute

to their knowledge base while easing the financial burden on your family.

Should she have any problems, she can always withdraw from the study, and

actually, they're probably ethically bound to continue to care for her for a

period of time after that. Sounds like a win win to me.

Best of luck to your family, and welcome to the group,

Kate F

[ ] Humira trial

I have been lurking and learning since posting a couple of weeks ago

about my 21-year-old daughter with positive RA blood work. We went

to the rheumatologist Monday and he didn't have any trouble

diagnosing her with RA. Her hand and feet x-rays show a lot of

osteopenia but no erosions - is this fairly normal? They are talking

about putting her in a trial of Humira to see if it works as well

with 80 mg once a month as opposed to the current 40 mg twice a

month. All you Humira users and others, does this sound like a good

idea, not really knowing if she is getting the 40 mg every 2 weeks or

80 mg/placebo every two weeks, or possibly a placebo only every 2

weeks for up to 12 weeks (then would defintely get the Humira if on

the placebo first)? The study is for 6 months and all medical care

and medicine would be free during this time (no insurance, so can't

fault that part of it anyway).

If she didn't end up getting the drug, would she be horribly set

back - Dr. didn't really say how aggressive it was but she has been

showing hand/feet symptoms since December and x-rays looked pretty

gray/osteopenic at the bone ends. She can keep taking her meloxicam

through the study, but she's struggling a bit as a full-time surgical

tech student and is beginning 3 10-hour days of clinicals this week;

is not really seeming inflamed right now but is quite uncomfortable

and not sleeping well at all.

Does this sound like a good idea or should we try for getting into

one of the drug programs for free/reduced cost drugs (as I'm pretty

sure we would qualify) and forgo the free medical care and study?

Thanks for any advice/ideas,

Beth

__________________________________________________

April 9, 2008

Beth,

I was part of the clinical trials for remicaide and I would go with

the study. Yes, it's a double blind study and you really don't know

if your getting the medication or the placebo. The nice part is if

she does get the medication and responds well to it, the chances of

health insurance covering the medication (at the trial dose) would

get approved. After my trial was finished, my health insurance

company approved my remicaide infusions. (It was a study to see of

remicaide can help those who are newly diagnosed w/ RA. Most

healthcare insurances at the time only approved remicaide after gold

shots and 2 oral medications didn't offer patients relief. My

rheumatologist at the time had to submit that I was part of the trial

and responded well to treatment and it would be better for me to

continue the remiciade infusions). Trials offer free medication and

free follow-up care with a rheumatologist for 6 months and most

reimburse you for your time and travel. Think of how much you would

save in follow-up fees. I assume the manufactuer of Humira is

sponsering the trial, if she reponds well in the trial...the chances

of them approving her for Humira (free or reduced cost through their

specific program based on income) after the trial I think are fairly

good.

I am on lyrica for fibromyalgia and I don't have any healthcare

insurance...my rheumatologist did the paperwork for me through

lyrica's manufactuer Pfizer and I get the medication for free. Most

pharmacudical companies have programs like that to help those who

cannot afford their medication.

Too answer your question, I would definately do the study.

>

> I have been lurking and learning since posting a couple of weeks

ago

> about my 21-year-old daughter with positive RA blood work. We went

> to the rheumatologist Monday and he didn't have any trouble

> diagnosing her with RA. Her hand and feet x-rays show a lot of

> osteopenia but no erosions - is this fairly normal? They are

talking

> about putting her in a trial of Humira to see if it works as well

> with 80 mg once a month as opposed to the current 40 mg twice a

> month. All you Humira users and others, does this sound like a

good

> idea, not really knowing if she is getting the 40 mg every 2 weeks

or

> 80 mg/placebo every two weeks, or possibly a placebo only every 2

> weeks for up to 12 weeks (then would defintely get the Humira if on

> the placebo first)? The study is for 6 months and all medical care

> and medicine would be free during this time (no insurance, so can't

> fault that part of it anyway).

>

> If she didn't end up getting the drug, would she be horribly set

> back - Dr. didn't really say how aggressive it was but she has been

> showing hand/feet symptoms since December and x-rays looked pretty

> gray/osteopenic at the bone ends. She can keep taking her

meloxicam

> through the study, but she's struggling a bit as a full-time

surgical

> tech student and is beginning 3 10-hour days of clinicals this

week;

> is not really seeming inflamed right now but is quite uncomfortable

> and not sleeping well at all.

>

> Does this sound like a good idea or should we try for getting into

> one of the drug programs for free/reduced cost drugs (as I'm pretty

> sure we would qualify) and forgo the free medical care and study?

>

> Thanks for any advice/ideas,

> Beth

>

April 9, 2008

Beth,

this would be a great study for her since you lack insurance. It will give her

a chance to try a biologic with out spending up to $4000 out of pocket.