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Auxilium AA4500 Phase 3 Clinical Trial Experience
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11/07/07 23:11
GPM 
11/07/07 23:11
GPM 
Auxilium AA4500 Phase 3 Clinical Trial Experience

Last Tuesday I had an injection of clostridial collagenase as part of the Clinical Trial. Prior to the injection I had a 25 degree contraction of the ring finger on my right hand, and a 20 degree contraction of the middle finger. I had a distinct cord running from my palm to the second joint of my ring finger, with a good sized nodule just below the joint.

The injection was made along the first crease in my palm and I think there were two separate injections, right next to each other. The experience was something like a novicane injection at the dentist. The needle was moved around a bit hitting the cord in a few spots. Immediately following the injection my hand was wrapped, mainly to keep me from using it much. the wrap was to be removed at bed time. When I removed the wrap my hand had swelled to the size of a small grapefruit. The bulk of the swelling was on the back of my hand. I was told the next day that was normal since the back of the hand has loose skin and will swell easiest.

Twenty four hours after the injection I returned to the doctor's office. The doctor attempted to snap the cord three times by extending my ring finger. Now, being a male and obviously not equipped to deal with much pain, this was not pleasant. The pain felt like a knife slicing through my palm. I involuntarily yanked my hand away each time. The doctor then fashioned a splint to straighten my ring and middle fingers, and I left with instructions to wear the splint at night, along with a set of stretching exercises to be performed four times a day.

Within two days the swelling was mostly gone. The splint went from being quite painful to being easy to wear. It has a metal band that allows it to be adjusted as the fingers straighten. Over the next few days I attempted to pull on the finger to snap the cord, same painful results.

Yesterday I returned to the doctor for my one week visit. Even the cord never did 'snap' both my ring and middle fingers measured at 0 degrees contraction. The cord is still there but it seems that it has loosened up a bit. Now, I never attempted to stretch my finger before participating in the study, so I don't know if I could have reduced the degree of contraction my just stretching or not. I still can't place my palm flat on a table, but I can come much closer than I could before the injection. With just a bit of effort, I can get my fingers pretty straight.

My next appointment is at the 30 day mark. At that point they will decide if I am considered a success or if they should inject again. The study allows for up to three injections in a single cord, and up to 5 injections if multiple cords are present. I suspect that if my fingers continue to measure at 0 degrees, I will be finished.

If anyone has any questions, I'll be happy to try to answer them.

Harry

11/08/07 01:41
JAnnRunner 
11/08/07 01:41
JAnnRunner 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

I was really glad to hear about your experience ( well minus the pain part) I had my first visit w/ hand doctor affiliated with the same study here in Indiana about 10 days ago. I went thru all the health tests ( blood work EKG, etc) They plan on starting me in 2 weeks with my first injection. The is a blind study so only 2 of 3 people will get the drug. But which ever shot I get I will still have to go thru the hand tugging so to speak. It sounds really painful!! My pip is 45 degrees now with 2 unsuccessful surgeries in 04 with NA not an option this is really my only chance.. I will keep you posted , thanks for the info
J Ann

11/08/07 02:51
GPM 
11/08/07 02:51
GPM 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

From what they told me, quite a few patients have their cord release before the first appointment after the injection. Perhaps you'll be one of those. Good luck...

11/08/07 08:36
wach 

Administrator

11/08/07 08:36
wach 

Administrator

Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

Very interesting experience! To me it sounds like the cord not being broken but to be pulled to a length that eliminates the extension deficit. That happens occasionally also with NA and is OK as well, I guess. The only concern might be whether the recurrence is faster if the cord is not snapped but stays in place. It might be so but I haven't seen any statistics on that.

Good luck to you and keep posting! I hope your posts encourage other people on the trial to tell their experience, too.

Wolfgang
PS: reading about your pain I wonder whether it would have made sense to let experienced NA practitioners to the trial. But I guess everyone needs to collect more experience how to handle those injections.

11/08/07 19:52
Randy_H 

Moderator

11/08/07 19:52
Randy_H 

Moderator

Returning the favor to BioS.

GMP:

I'm sure you know that there is a 33% chance that you are in the Control Group and haven't been injected with Collegenase at all. In a double blind design the doctor would not know either. Naturally he is going to give it his best effort to snap the cord regardless. But considering you got back to zero degrees of contraction which is impressive, it's hard to believe that a placebo could do that. Keeps us posted.

It's great having participants in these trials reporting here. Presumably BioS created their original Forum so that readers could monitor the progress this same way and promote their product. Unfortunately they ran out of money, the trials stalled, and we all would up talking about NA instead, which actually launched the NA movement in North America and now elsewhere :-) Now this Forum is returning the favor to BioS.

Finally now actual money is being spelt on Collegenase Phase III. We are probably still two years away from general availability, however. We should all keep our fingers crossed, at least those who can. If you can't, go get some NA in the meantime.

11/08/07 21:01
GPM 
11/08/07 21:01
GPM 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

Randy,

The trial being conducted by Hope Research in Phoenix is an Open-Label Study. From the Consent Form:

"The study is called an open-label study, which means you will receive AA4500 at each injection. Data from this study will provide effectivness and safety data for AA4500."

I was contacted by another site conducting a double-blind study, but chose the Phoenix study because I was guaranteed to receive the drug. And the fact that I live in Phoenix didn't hurt either.

11/10/07 21:39
JAnnRunner 
11/10/07 21:39
JAnnRunner 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

I still have not heard back form the hand center on the Auxilium AA4500 blind study in Indianapolis, I should here something this week to have my first injection on the 19th of this month w/ the other members of this study.. After reading a lot of your experiences I must say my mind in not at ease! I have 45 degree contracture in my pip joint of my dominate hand. I had told the doctor that I really need to be able to use my hand during the next 3 months and they told me I could w/ no problems. But I bet you guys might have a differnce of opinion! I can maybe put it off until December for my first injection but they want to start me soon. They told me I would be their youngest female thus far. If I am one of the un-lucky ones that do not get the drug I still will have to go thru all the same procedures as the people that do. I would after 90 days be able to get the drug if I was not lucky the first 3 months. I do have 6 new nodules ( small) in the same hand that was pointed out by the doctor during my 1st visit , but no contracture yest do to them.. So I know in the long run I will be glad that I am doing this but fo today I am a little unsure... Any advise would be welcome.. Oh by the way they said no pain medicine will be allowed in this study .

11/11/07 00:31
GPM 
11/11/07 00:31
GPM 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

I would say go for it. If you read the results of the studies so far the success rate is 91%. Also, average number of injections to success is either 1.4 or 1.5. To me this translates to 1/2 of the people achieve success (0-5 degrees contraction) after the first shot.

The shots themselves are not at all unpleasant. And if you're one of the 1/2 that has the cord release after the first shot, you'll be in great shape. In the week and a half since my injection the swelling is completely gone. I can extend the finger straight with a bit of pressure. My next appointment is at the 30 day mark. At that point the doctor will either judge the treatment a success, or I will get another injection. I can still feel the cord from the injection point toward my wrist. From the injection point to the finger the cord is much less pronounced than before, maybe even gone.

Another thing to consider is cost. I have no idea how long it takes for insurance companies to cover something like this once its approved. From what I've heard the cost for an injection will be substantial. The guy from Hope Research told me a single dose cost $1,000. If that's the doctor's cost, you can imagine what the charge to the patient will be.

11/12/07 07:42
newman 
11/12/07 07:42
newman 

Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

Australia Calling. Hi J.Anne , Don't wait I would take your chance as early as you can and take the treatment . You never know they may run out then what.Your health is the no.1 priority. Regards

11/12/07 10:19
TrevB 
11/12/07 10:19
TrevB 

Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

So what are the chances and timescale of these trials completing successfully, finance being in place, production of the treatment going smoothly and it being available generally?

Of course in the UK we'll have the added problem of approval by NICE:

NICE produces guidance in areas of health (including):
- health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS - clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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