Re: Question about clinical studies

[Guest guest]

Hi Cristina! My DH* is new to Psoriatic Arthritis too. (about 2

months) He is not using Enbrel but rather Humira. It has

helped him a lot. I say go for it. The Humira has really helped my

DH. He was in horrible pain about 2 months ago and now is feeling

pretty good. His psoriasis is just about gone too! Good luck!

" fit2bfit2003 " <aerobicfit@...>

*DH = " dear husband "

[Guest guest]

:  if you type in, Clinical Studies, what to know, there are several

websites that come up that could be helpful to you.  Here's one that should be

fairly reliable because it's the National Institutes of Health (ostensibly more

independent than, for instance, the American Cancer Society which also has info

available):  http://clinicalcenter.nih.gov/participate/studies.shtml

One of the main things to remember is that in many clinical trials, you may be

given a placebo - not the drug that's being tested - and you won't know which

you're getting.  (A placebo is basically a sugar pill so you might be getting no

treatment at all for your disease.)  This is one of the first things I'd

clarify.  I would also see what you can find out about any preliminary trials

(on people or animals) that have been done to date and their findings.   Is this

drug similar in nature to any other that is already on the market or that's been

taken off the market?  Also make sure that if any suspicious or

negative findings do turn up in the trial you're participating in that you will

be notified so you can make the choice to continue or not continue. 

They may not be willing or able to agree to all of these, but I'd sure ask at

least.  The FDA - which oversees drug testing and approval - has made some

really big mistakes over the years and all too often, they rely totally on the

company testing the drug for information; and obviously, the company has a

vested interest in seeing that drug get to market.  Look at what happened with

Vioxx, for example.   

 

I'm not at all saying that it's not a good idea.  But be an informed

consumer!!!!   Check out these websites.  They have lots of info and suggestions

of things you should consider before agreeing.  Somebody has to do it or new

meds would never get to market. 

  Joanna Hoelscher

[Guest guest]

Hi Cristina,

What is involved in the study? I know I let them monitor my progress

on Enbrel. If that's all it is, I'd say go for it. You get the stuff

free. Enbrel might really help you, it helped me about 3/4 of the

way. I've now switched to Humira.

Michele

> me to be a part of a clinical study. I was wondering if anyone on here

> has ever been a part of one of these studies? I don't know if I should

> do this or not. The doctor said that it is for a new drug like Enbrel.

[Guest guest]

:  I just realized that you said it's your dermatologist that wants you

to be part of a study.  Since you were diagnosed with PA, have you been to see a

rheumatologist?  If not, you probably should before agreeing to any kind of

clinical study.  PA could already be doing great damage to your joints and a

rheumy may not want you to risk any further - and potentially permanent harm -

by trying a drug that has not yet been proven to be effective. 

 Joanna Hoelscher

[Guest guest]

Thank you all for some very good things for me to think about and

questions to ask tomorrow when I go back to the doctor. The

dermatologist that I am seeing has done a great deal of study on PA.

He has written several articles about it and seems to know a a lot about

PA. They did tell me that there will be no placebo, I would get either

Enbrel or the new drug like Enbrel. The nurse said that the company is

trying to prove that their drug is as good as Enbrel. So at least I

know that I am actually getting something for all my time spent. It

only comes in a shot form so I am very nervous about having to give

myself shots. I HATE needles! I will know more about it after I get a

chance to read the paper work and talk with the nurse tomorrow

afternoon.

Thank You all so very much,

Cristina

Indiana

[Guest guest]

- Since you are newly diagnosed with PA Does that mean

you haven't been on Naproxen or MTX (or another DMARD*) yet? It may

not be beneficial for you to do the trial because maybe Naproxen or

a DMARD could treat your PA and you wouldn't have to be on a TNF

blocker such as Enbrel. Not only is it a very expensive drug but

from everything I've learned, (someone please correct me if I'm

wrong) I would rather be on a DMARD that completely treats my PA

than a TNF blocker.

& Grant (11, PA/Uveitis)

*Disease modifying anti-rheumatic drug

[Guest guest]

There aren't any clinical studies in my area right now, but if there

were and they offered me a chance to participate, I would do it in a

heartbeat. Especially if I was guaranteed to get either something like

Enbrel or Humira at least, if I wasn't double-blinded into the section

of the study receiving the experimental drug. DMARDs, labs, and

physician followup for free? Oh yeah, I'd be there. Those drugs are

EXPENSIVE.

Now, if it was a double-blind study where I'd be getting some sort of

placebo versus getting the study medication, I'd say forget it, unless

I was guaranteed to be in the group getting the medication.

" dreimutter1957 " <dreimutter1957@...>

[Guest guest]

Sometimes there are things that contraindicate treatment with MTX, for

example elevated liver numbers. Anyone who has or has had a problem

with elevated liver enzymes would not be a good candidate for treatment

with MTX. The anti-TNF-alpha DMARDs are not so hard on the liver.

" S. Zorzi " <szorzi_1999@...>

[Guest guest]

Joanna - Naproxen has done a great job in treating my son's PA. It

took away all his inflammation. I know that NSAIDs don't stop the

progression of PA but it is the inflammation that does the damage to

the joints, right? So if there is no inflammation,(and no pain in

Grants case) that is the best we can expect right now, isn't it,

since there is no cure?

& Grant (11, PA/Uveitis)

[Guest guest]

Okay, here is the scoop as I know it on this clinical study. The

meds. come into the office today. I will be administered a shot. It

will be either (a) Enbrel 40% chance of getting ( new drug with no

name 40% chance of getting or © placebo 20% chance of getting.

Now if we get started on one of these shots and after a couple of

weeks we see no progress at all, they are going to assume that I am

on the placebo and they will then take me out of the study. They

want me to be able to get the drugs free of charge if they are going

to work. But if I get the placebo, they are afraid that at the rate

that this is progressing for me, that a 3 month study on nothing more

than a placebo will be wasting too much precious time. It came from

no where & now every day I seem to be worse than the day before!

But, now we don't know if I can get into the study because my husband

had a vasectomy 9 yrs. ago and the company running the study does not

consider this to be birth control. RRRRRR!!!! I have never been with

another man, we have been married 21 yrs. and I do not plan on

finding another man to be with. That should be enough. I explained

this to my dermatologist, so he is going to bat for me on this one

and is going to tell them all of this. The nurse told me that the

Dr. is going to ask them " Do you want her or not, the way it all

stands now? " I guess we will see what happens from here. It is all

in God's hands, if I am to be in the study, then it will all fall

together and happen for me. If not, we will find some other way to

get the meds.

Cristina Gingerich

Indiana

[Guest guest]

Well, I didn't make it into the clinical study. The birth control was

the problem. They said because of rape, I would still not be covered.

But it all worked out because they were not going to let me leave the

office without getting something. They were able to get me the 12

weeks of free medicine through a different deal and then we will

figure out from there what to do next. So, I took my first Enbrel

shot yesterday! The shot itself wasn't nearly as bad as what I

expected. But I was sick all evening and most of the night. Chills,

fever and bad stomach pain where the shot was placed. But, This

morning I feel some better. About a half hour after taking my

Arthriten this morning, I can make a loose fist, not real good yet

but I haven't been able to bend my fingers for about two months now.

I don't know if it is a fluke or if it is from the Enbrel.

Does the being sick with chills and fever go away or will I be

fighting this the entire time? And do the shots always make your

stomach sore in the spot where the shot was given? I feel kinda like

I did a hundred sit ups. Still, I am glad to be getting help, just

hope I can stand to keep going with it.

Cristina Gingerich

Indiana