My Third Abatacept Study Treatment

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Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 10/15/2007 7:49 PM (GMT -7)   
For those that have been following my clinical trial for UC, today I had my third treatment of Abatacept or placebo. The last treatment was 2 weeks ago and I have had little improvement since then with 7 or 8 urgent bloody BMs per day over the weekend. I arrived at the hospital about 1:00 pm and the study nurse immediately called the hospital pharmacy to have the Abatacept mixed. The infusion room was full and there was no room for me so I sat in the hall and received the treatment there. The hall chairs were also recliners and I think they are actually softer and more comfortable then the chairs in the infusion room. The nurse took my stool sample that I brought from home, daily log of my symptoms, and took a blood sample for the study. She also gave me $20 to cover my expenses.

Another attractive female study doctor who I met at my prescreening scope a month ago was waiting for me and wanted me to participate in two more studies. One was to study the “Incidence of Antibody Formation after Maintenance Infliximab (Remicade) Treatment for Ulcerative Colitis”. This study requires a one time blood sample. I had taken 7 Remicade infusions from August 8, 2006 to February 14, 2007 with no improvement in symptoms. This study will help in the understanding of why patients develop infusion reaction to Remicade and therefore a lesser clinical response. The information obtained will also help in the planning of future studies to evaluate drugs that may block the effect of antibodies. The study will also check for serological markers which may influence disease severity and response to medications. I signed the consent forms, answered a 5 minute questionnaire and gave the blood samples.

The second study was for “The Identification of Genes for Inflammatory Bowel Disease”. Again this study requires a one time blood sample. This study will help identify gene-containing areas which are involved in IBD and help identify the specific biomarkers (genes, gene expression patterns, serum markers, etc.) which are directly involved in IBD and to understand the role these genes play in causing IBD allowing for the possibility to discover new diagnostic test and better, safer therapies. I signed the consent form and they took the blood sample. I gave a lot of blood this time I hope I have enough left. lol. I was then told I could go for lunch and returned at 2:00 pm.

When I returned the nurse hooked up the IV line to my arm and took my temperature, pulse and blood pressure. She then started the Abatacept or placebo infusion. Half way through the treatment the study doctor came in and performed a physical examination on me.

One other patient is participating in this study and he was in the infusion room when I arrived. He left for lunch about the same time I did but he did not return. The study nurse was very angry. The medication was already mixed and had to be used the same day. When I finished he still had not returned.

The first two infusions consisted of 2 bags of medication and took about 1 ½ hours and I had to wait for 1 hour after for observation before I could leave. This infusion consisted of one bag of medication and took only a half hour with another half hour wait. I finally left the hospital at 3:30 pm. My next infusion is in 4 weeks and I will have a second sigmoidoscopy on the same day.

Take care,
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
 


Sara14
Veteran Member


Date Joined Mar 2007
Total Posts : 4034
   Posted 10/15/2007 8:36 PM (GMT -7)   
Thanks for sharing! Sorry to hear you're not really improving. It must be frustrating not to know if you have the actual medicine or a placebo...at least it would be for me. Keep us posted.
23 years old
Diagnosed with UC March 2007
Current inflamation in the rectum
Asacol 4 tablets 3x/day
Rowasa (generic) - nightly
Nature's Way Primadophilus Reuteri 1/day; Chewable multivitamin; experimenting w/fiber supplements (Metamucil and Fiber Choice); Viactiv (Calcium and Vit. D) for Osteopenia; ground flaxseed


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 10/16/2007 3:34 AM (GMT -7)   
Thanks Sara, I’m starting to think I may be getting the placebo but I really don’t know for sure. The treatment has made absolutely no difference, good or bad. If I don’t improve both in symptoms and the amount of inflammation at my next scope in a month, I will be able to get the real medication stating another month after that. If I do improve I will get a maintenance dose and could possibly get the placebo.
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 10/31/2007 8:04 PM (GMT -7)   
Hi Paul & Sara. I've been on the Phase 3 Abatacept trial for UC since April 2007. Seems I scored the placebo in the initial trial phase and was moved over to the open Label phase late June 2007.

There are 5 other people in the trial with me that I know of. 3 of us have UC, 1 has chron's and one has both.

For those of us with UC, it seems that Abatacept DOES work, it just takes quite a bit longer then it does for the chron's people. 2 to 3 infusions for chron's and around 4 to 6 for UC.

I have had 5 open label infusions (one per 4 weeks) in the open label and it has just started to work for me as I have been able to reduce my prednisolone intake from 30mg a day down to 4mg without the symptoms flaring up.

I am also sleeping better (I was having to wake up and go to the toilet around 8 times a night, now its around 2 to 3 times), I can sleep on my front, back, sides now rather then only on my back, and the urgency in which I need to find a bathroom has reduced quite noticably. I used to need to find a toilet within 2 minutes where as now I have about 15-30 minutes.

My other medication includes Balsalizide and 6-MP.

Outside of the meds, I am also taking:
- fish oil (6 x 1g caps, 3 times a day);
- Ultrabiotic 45 bacterial probiotic (from bioceuticals) (1 capsule, twice a day);
- SB Floractiv yeast probiotic (from bioceuticals) (1 capsule, twice a day);
- L-Glutamine suppliment (1 tsp, twice a day);
- Protein and vitamin suppliment.

And a good dose of exercise each day. I prefer swimming as it doesn't knock my insides around as much.

Hope you also get some solid results from this trial too!

--------------------------------------------

"We are the music makers, we are the dreamers of dreams"

DeniseW
Regular Member


Date Joined Nov 2005
Total Posts : 346
   Posted 10/31/2007 9:29 PM (GMT -7)   
Where are you guys at? My mother-in-law seems to think the new doc I have in Houston would know about all these trials and put me in one (though I would still like to have another child before that). Anyway, he didn't say anything about any options other than remicade and imuran for me, even after we asked about 10 times. I'd gather he knows, but couldn't get people into a study like that here.
dx 4/05 with pancolitis UC after birth of my second child... meds worked randomly
SCD and vit e enema remission for 18 months and had another drug free baby 10/06
Let flare get out of control and even steroids wouldn't work 7/07 - docs wanted surgery
lialda x4 daily and started remicade 10/26/07
 
 


Severin
Regular Member


Date Joined Oct 2007
Total Posts : 320
   Posted 10/31/2007 9:37 PM (GMT -7)   
Hi DeniseW. I'm in Australia. Though if you want a list of trial sites world wide, check out the following link:
http://clinicaltrials.gov/ct/show/NCT00410410

I did the same thing. Let a flare get out of control rather then go right in and see my specialist. Very stupid of me and it has taken nearly 2 years to pull it back under "some" kind of control. I have sworn to myself that I will never make that mistake again!

I am now also a huge fan of fish oil, glutamine and probiotics. I have found that they have helped a great deal as well.

DeniseW
Regular Member


Date Joined Nov 2005
Total Posts : 346
   Posted 11/1/2007 1:29 PM (GMT -7)   
Thanks for the site! I will look into it again when I'm done having kids. I'd love to be in the gene one, but I didn't see it on there. My doc says they have 4 of the genes for it, so I pray gene therapy isn't too far down the line. Probably longer than I will make it, but maybe it'll be there for my kids.
dx 4/05 with pancolitis UC after birth of my second child... meds worked randomly
SCD and vit e enema remission for 18 months and had another drug free baby 10/06
Let flare get out of control and even steroids wouldn't work 7/07 - docs wanted surgery
lialda x4 daily and started remicade 10/26/07
 
 


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 11/1/2007 8:32 PM (GMT -7)   
Severin, thanks for your experience. They don’t reveal who was on the placebo until the entire study is complete and all the data is in. If you didn’t respond to the blind portion of the study but did to the open label then you may have had the placebo. You just don’t know for sure. Unfortunately if Abatacept DOES work for some, it doesn’t necessarily work for all. No current treatment works for everyone with UC. I’m glad that it is helping you. Your symptoms were much worse than mine.


Denise, I’m in Toronto, Canada. Most doctors won’t recommend you enter a study unless you have already tried most conventional treatments. Most studies are done at teaching hospitals and you may need a referral. If I were you I would try Remicade and Imuran before considering a clinical 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
 


Old Hat
Veteran Member


Date Joined Feb 2007
Total Posts : 5135
   Posted 11/2/2007 10:12 AM (GMT -7)   
Thanks for update, Paul. You are really doing all UC patients a big favor by contributing bloods to the other studies, too. Good luck with the next stage of trial. / Old Hat (nearly 30 yrs with left-sided UC ... [etc.])
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