Abatacept/Orencia?

New Topic Post Reply Printable Version
[ << Previous Thread | Next Thread >> ]

Eva Lou
Veteran Member


Date Joined Sep 2006
Total Posts : 3437
   Posted 11/29/2007 10:20 AM (GMT -7)   
who's on this stuff? And is it thru a clinical trial, or was it actually prescribed to you by your GI? I don't think it's been approved yet for anything other than Rheumatoid Arthritis, so is your insurance paying? And how is it working, most importantly!!!!!? Just curious.... I've been spending time on the Crohn's Disease forum, & they mention a global trial of this stuff. Any of you diagnosed with UC using it?
diagnosed with UC '02
meds-
Asacol- 8 tabs/day
Remicade infusions
Imuran- 100mgs/day
Prednisone- 15mgs/day
 


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 11/29/2007 12:50 PM (GMT -7)   

I’m on the Abatacept clinical trial for UC and I received my first infusion last September 17. I have had 4 treatments with the last one on November 15. I have not noticed any improvement yet but I may be on the placebo. I just don’t know for sure. Over the last few months I have had 4 to 9 urgent bowel movements with blood on most of them. I also had a flex sigmoidoscopy on September 17 and November 15. No noticeable improvement was observed. I have my next scope and treatment December 10. On that day if I show less than 30% improvement based on the scope and symptoms I will enter into the open label and receive the real treatment.

 

This study is being conducted around the world. More info can be found at:

 

http://clinicaltrials.gov/ct/show/NCT00410410;jsessionid=28315F760B0607A2A6B8FE4361474640?order=42

 

This is a Phase 3 study and is the last study before it may be approved. From the above link the expected completion date is December 2009. It would not be approved until after that date.


Paul
Diagnosed in 2000 at age 43 with UC extending half way across transverse colon.
Allergic reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Currently in Abatacept trial - waiting for remision
 


Eva Lou
Veteran Member


Date Joined Sep 2006
Total Posts : 3437
   Posted 12/1/2007 7:44 AM (GMT -7)   
WOW! How frustrating to not know if you are getting the placebo or not! I mean, based on the flex sig, I'd assume you are getting the placebo- or that the drug is not what the researchers thought it owuld be! But then again, looking at your history with meds... nothing much seems to work for you. Yuk! Please, let me know how the flex sig on the 10th turns out- I'm really curious about this drug. So far the high Remicade dose has been helping me, every 6-7 weeks. But as I taper off pred, per usual, my symptoms are slooooooooowly increasing. Same old, same old..... Now if the scope on the 10th shows no improvement, what does "enter into the open label & get the real treatment" mean? That you are in fact currently receving the placebo, or?????? And was it a pain to enroll in this trial? Did your GI have to jump thru hoops to get you in, does it cost anything, did your insurance give you grief over paying for it?
diagnosed with UC '02
meds-
Asacol- 8 tabs/day
Remicade infusions
Imuran- 100mgs/day
Prednisone- 15mgs/day
 


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 12/2/2007 9:38 AM (GMT -7)   
I have posted a lot of information about the Abatacept trial and my experiences. You can view some of them at:
 
open label refers to the real medication and not the placebo. If I go on the open label it does not necessarily mean I had the placebo. I will not know for sure if I was on the placebo or not until the entire study is complete and all data is analyzed. It could be another year or two. It is called a double blind study because both the patient and the study doctor do not know who recieves the placebo.
 
To enroll in a clinical trial you must be referred to a GI at a hospital or clinic that is involved in the study. Each study has its own eligibility criteria. I had to go through a prescreening visit to determine my eligibility which included a physical exam, scope, blood, urine and stool samples. You are only allowed to be on some other medications such as 5ASAs, Imuran or 6-MP but you must be on a stable dose for a certain amount of time. For the Abatacept trial Remicade was not allowed. I had to be off of it for a minimum of 12 weeks before entering the study.
 
This study is conducted by Bristol-Myers Squibb, the manufacturer of Abatacept. They pay for everything, including all doctor visits, scopes, prep and the medication itself. In fact they even pay me $20 for each visit to cover my out of pocket expenses. Insurance companies are not involved at all. If the treatment helps me they will continue to give it to me at no cost until it is approved for general use. At that time your insurance company should cover the cost.
 

Paul
Diagnosed in 2000 at age 43 with UC extending half way across transverse colon.
Allergic reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Currently in Abatacept trial - waiting for remision
 


Severin
Regular Member


Date Joined Oct 2007
Total Posts : 320
   Posted 12/3/2007 9:32 PM (GMT -7)   
Hey Eva Lou!

I've been on the UC Abatacept trial since August 2007. My Gastro specialist thinks I copped the placebo first off. I was taken off the "unknown trial dose" at the end of July 2007 and have been recieving the real "open label" stuff since then.

It took 5 infusions for it to take noticable effect. I find it kicks in exactly 14 days after the injection and the effects last between 2 and 3 weeks before things start to fall off again.

Abatacept has been great as I have been able to drop from 50mg of pred in July to 2mg of pred at present.

The people in the trial I know who have CD appear to get effect faster then the UC people in our group.
"We are dreamers, shapers, singers and makers..." - Elric, elder Technomage

Post Edited (Severin) : 12/3/2007 9:40:06 PM (GMT-7)


Eva Lou
Veteran Member


Date Joined Sep 2006
Total Posts : 3437
   Posted 12/4/2007 10:06 AM (GMT -7)   
well thanks for the info, guys- I have no intention of trying to get into the study, as the Remicade has been working pretty well for me. But I am always interested in hearing about new meds, & how people do on them. Is it a biologic? Those drugs have really taken off in the past year or so- they seem to me to be the wave of the future as far as treating Crohns/UC.

diagnosed with UC '02
meds-
Asacol- 8 tabs/day
Remicade infusions
Imuran- 100mgs/day
Prednisone- 15mgs/day
 


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 12/4/2007 7:43 PM (GMT -7)   
Both Remicade and Abatacept are biologics but they act differently. Remicade is a TNF blocker and Abatacept acts on T cells. Abatacept is a good alternative for people that don’t respond to TNF blockers such as Remicade or Humira. After using Remicade I was tested for antibodies and none were found. That meant that other TNF blockers probably wouldn’t work and that is why I went for an Abatacept trial instead of a Humira trial.
Paul
Diagnosed in 2000 at age 43 with UC extending half way across transverse colon.
Allergic reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Currently in Abatacept trial - waiting for remision
 


Robert.K
Regular Member


Date Joined Nov 2007
Total Posts : 137
   Posted 12/4/2007 7:54 PM (GMT -7)   
I just want to say I admire anyone who takes part in a clinical trial! Your participation is vital to the advancement of new medications. It is a big commitment and it's great for the rest of us. Thank you!
New Topic Post Reply Printable Version
Forum Information
Currently it is Tuesday, December 12, 2017 5:05 PM (GMT -7)
There are a total of 2,904,569 posts in 318,769 threads.
View Active Threads


Who's Online
This forum has 158155 registered members. Please welcome our newest member, Wyatt40.
393 Guest(s), 17 Registered Member(s) are currently online.  Details
Alcie, skeye, Tim G, Break60, DianeB, Purrrsiankitty, paniccu, 1000Daisies, rafaeltoral, Laugh and live, magoo2, cr3ativegirl, Dreamerboy, David_in_VA, momem3, Nowitshell, iPoop