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Auxilium AA4500 Trials Report.
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11/19/2007 23:13
bshatzer 
11/19/2007 23:13
bshatzer 
Auxilium AA4500 Trials Report.

Went in for my first (and hopefully last) set of injections this morning.

Went in about 8 o'clock and had the blood draw. Then it was wait, wait, wait. 'Bout 10 they finally got around to starting the actual process - hand examination, finger measurements, blood pressure readings, medical history review, the usual battery.

The actual injection was held up because the doctor messed up the mixing and they had to take a new packet out of the refrigerator and let it warm up for 15 minutes before it could be injected. You never want to hear your doctor say, "Wait, I think I've screwed up," but better, I suppose, before the injection than afterwards or during.

The injections themselves were not the worst pain I've ever experienced but they were bad enough that had I been a prisoner, I would have talked! Still, the entire process of all three injections didn't take more than 45 seconds or a minute.

After the injection they monitored my vital signs for a full hour so it was almost noon before they released me.

There don't seem to be any significant side effects. There was a short-lived numbness in my ring and little fingers (doctor said "normal") and a metallic taste in my mouth (psychosomatic?) at the time of the injections but those passed rather quickly. My hand is swathed in a large gauze dressing and there's some soreness in the palm of the hand itself but nothing more than a minor discomfort.

Tomorrow morning I return to "break the cord" - not anything I'm looking forward to but necessary I suppose.

The nurse indicated that they've been having good results with the trial so far. Only one person so far (out of ten) has failed to obtain complete straightening with only the single set of injections so I'm hopeful.

We'll see how it goes tomorrow.

11/19/2007 23:35
Randy_H 
11/19/2007 23:35
Randy_H 

Re: Auxilium AA4500 Trials Report.

We all should be very please and excited to be hearing from Phase III trial participants. The results will have significant impact on the future treatment of our disease.

It would be helpful for those reporting their experience to list which joint(s) are being corrected. The MCP is the first joint from the palm. The PIP is the next joint down the finger. Also, what degree of contraction did you start at?

The reason is two fold. One, the PIP is always harder to correct. Two, the greater the starting contraction of a PIP the harder it is to get it completely straight.

Thanks

11/20/2007 02:33
GPM 
11/20/2007 02:33
GPM 
Re: Auxilium AA4500 Trials Report.

Good luck tomorrow. My cord didn't snap on day two, but by the end of the first week both fingers measured at zero degrees. It did take just a bit of pressure to get them straight. Now, three weeks after the injection I can straighten both fingers.

My ring finger measured 25 degrees and my middle finger measured 20 degrees, both MCP.

11/21/2007 02:03
bshatzer 
11/21/2007 02:03
bshatzer 
Re: Auxilium AA4500 Trials Report.

Well, danggit, it didn't work. Despite much pushing by the doctor (and a bit of yelling on my part), the darn thing wouldn't snap.

The doctor didn't seem terribly disappointed but I certainly was. Still, he's got me in a nighttime splint to put pressure back on the finger and a exercise regimen to loosen things up. He says the cord will continue to weaken and sometimes just goes by itself or during the course of the finger exercises. If not, I'm scheduled in next Monday for another try.

I certainly hope I don't end up as their second failure.




11/21/2007 14:13
GPM 
11/21/2007 14:13
GPM 
Re: Auxilium AA4500 Trials Report.

That hurt didn't it. My Doctor made three attempts to snap mine and finally gave up when I kept pulling my hand away. Don't be too disheartened by the lack of a break. By the end of the week my fingers could be gently pushed straight and now I can fully straighten them by just stretching. I have my one month follow up next week. I suspect that since I can straighten my fingers, no follow up injections will be needed. I can still feel a couple of lumps in my palm, and I can still feel the cord in most places. The dimple I had in my palm is gone.

Did you have much swelling? The back of my hand was quite swollen. It took three or four days to go down. I also had some discomfort in my right armpit the day following the injection. The Doctor said it was probably lymph nodes, although she couldn't feel any swelling.

11/22/2007 04:47
bshatzer 
11/22/2007 04:47
bshatzer 
Re: Auxilium AA4500 Trials Report.

Yeah, quite a bit of swelling and bruising. My daughter says it looks like I shut my hand in a car door - which isn't a bad description. Still, the swelling is subsiding and the bruising and discoloration seems to be abating as well, though not as fast as the swelling is going down. And the whole thing is not particularly painful now except when I'm doing the exercises trying to stretch the little bugger. The splint was uncomfortable enough that it woke me a couple of times during the night and I finally had to take it off about 3:00 am or so. Perhaps tonight will go better.

The attempt to straighten the finger involved considerably more than just "discomfort" as the disclosure statement described it - in fact it hurt like hell. But the doctor assured me I didn't wimp out - that he applied about as much pressure as he wanted and he was about ready to stop when I yelled "stop".

We'll see how it goes from here. I was kinda hoping for a magic bullet but apparently that's not to be. Hopefully, the next thirty days will be more productive than the first two and the thing will eventually work as advertised.


11/27/2007 03:11
bshatzer 
11/27/2007 03:11
bshatzer 
Re: Auxilium AA4500 Trials Report.

Follow up visit today. The doctor says the finger "seems" more flexible but there's no improvement in the finger angles as measured by his little gauges. I certainly can't see or feel any significant improvement.

The plan is to continue the exercises and night time splint for the next three weeks with an appointment scheduled for the 17th of next month. If the finger isn't straightening by then, the injection procedure will be repeated - shudder!




11/27/2007 04:56
moondanc 
11/27/2007 04:56
moondanc 
Re: Auxilium AA4500 Trials Report.

Bshatzer and GPM --You guys are scaring the heck out of me -- you said your hand looks like it was slammed in a car door? Whew-- I'm starting to feel like a bit of a chicken. I go in for my blood work and EKG tomorrow. Does anyone know whether a person will get reactions-- hand or arm swelling or lymph nodes swelling if one receives placebo/saltwater? And what's this about tendonn blow-out? It is my understanding that there have been "serious adverse events" in previous trials but “None of the serious adverse events that occurred were attributed by the investigators to the study drug.” Wouldn't tendon blow-out qualify?

Are you in double blind or study drug only trials?

Thanks!

11/27/2007 13:37
GPM 
11/27/2007 13:37
GPM 
Re: Auxilium AA4500 Trials Report.

I'm in a drug only study trial, so everyone gets the real thing. In my case, the effects of the injection probably sounded worse, and certainly looked worse than it was. The back of my hand was pretty swollen 12-18 hours after the injection. The injection site was bruised and tender. The swelling began to go down on the second day, and was completely gone within 3 or 4 days. The tenderness has also gone diminished to the point that it is probably less sensitive than it was before the injection.

I'd never heard of the tendon blowout issue until I read about it here. That does not sound pleasant. Perhaps you can ask more about it at your screening. I have my one month follow up today, and expect to receive no more injections since my fingers measured zero degrees contraction at my last appointment. If I had it to do over again, I would certainly go ahead with the trial.

12/03/2007 18:09
bshatzer 
12/03/2007 18:09
bshatzer 
Re: Auxilium AA4500 Trials Report.

Two weeks after my initial injection, there seems to be progress - Yea!

The PIP angle on the little finger seems to have decreased noticeably. I'd estimate it is now closer to 30-35 degrees as opposed to 60-65 degrees before the injection. Still no "snap" on the cord and the nodules on the palm remain rather pronounced and hard but things are looking better.

My experiences post-injection mirror GPM's. The swelling and discoloration looked worse than it felt - minor discomfort and tenderness is probably the best way to describe it though it looked fairly ugly for a couple days. The swelling and discoloration were largely gone by the third day and it's completely disappeared now.

I'm faithfully doing my exercises and wearing the night time split. Progress seems slow but there is progress. Perhaps the second set of injections will not be required. If they are, I at least have some positive signs that the stuff works and a second round of injections might finish the job.



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