My First Abatacept Open Label Study Treatment

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Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 12/16/2007 8:44 PM (GMT -7)   
For those that are following my UC clinical trial for Abatacept I had a flexible sigmoidoscopy and study treatment last Monday. I would have reported earlier but I have been very busy lately.

I was worried that I wouldn’t make it to the appointment for the sig. A week earlier we had freezing rain here in Toronto and I slipped on the ice in my driveway. I fell straight back and hit my head pretty hard on the driveway. I had a huge bump on the back of my head and some bleeding. It took me a couple of minutes to get up because I was dizzy and disoriented with blurred vision. When I got up I immediately put salt on the ice to prevent anyone else from slipping. That night I couldn’t sleep. I was dizzy with blurred vision. I didn’t go to work in the morning and I called my family doctor. They said to go straight to the hospital emergency. Five hours and a CT scan later the emergency doctor told me to take extra strength Tylenol and go home and get some rest. I was off work for 2 days. It took a few more days before I started to feel almost normal.

I really didn’t want to start the prep before I was back to normal. Sunday morning I finally felt normal except for a tender spot on the back of my head. The prep went reasonable well and I got to the hospital admitting office at 8:00am Monday morning. The scope was at 9:00am. When I was in the examination room the study doctor did a physical examination on me and asked a few questions. My UC symptoms have not improved with 6 or 7 bloody BMs every day. He performed the scope and said there was no improvement since the last scope. The scope was over by 9:30am.

I then went to meet with the Study coordinator. I gave her my symptom log, blood samples, urine sample and a stool sample taken before I started the scope prep. She gave me $20 for the visit and $25 for the cost of the prep. This was an important visit in the study. I have already had 4 treatments in the Induction Period of the study and I don’t know if I received the placebo or not. If I have a minimum of 30% improvement I will enter the Maintenance Period with a 50% chance of receiving the placebo whether or not I was receiving it already. If I don’t have the 30% improvement I would then enter the open Label Period and receive the actual medication with no chance of getting the placebo. The study coordinator told me she had to submit the results of my recent log and sig to the sponsoring company and they will compare the results to when I first started the study. She had to wait for the results before she could give me the next infusion. She told me to meet her at the infusion centre at 11:30am.

I was starved so I went to the food court across the street and found that most of stores didn’t open till 11:00am and it was only 10:00am. Subway was the only one open so I went for it. I got back to the infusion centre at 11:30 and the study coordinator arrived at 12 noon. She told me that my original score when I started the study was 9 and that I needed a score higher than 6 to enter the open Label Period. This visit I had a score of 10. She had just picked up the real medication and I am now officially in the open Label Period. She also told me that the other patient in the study also is entering the open Label Period. He started the study the same day as me and has received his treatments and scopes the same days as me.

The study coordinator then administered the real Abatacept starting at 1:00pm. I will be able to stay on the open Label until Abatacept is approved for use for UC or until the study is over. If it doesn’t work for me I can stop it at any time. I plan to have at least 5 treatments before I decide if I stop it or continue. I will have to discuss it with the study doctor at that time. While I was being infused I filed out 4 different questionnaires, each containing 20 to 40 questions. They asked everything from my current symptoms for the last 2 weeks to questions about my sex life, emotional state and energy levels. It was quite intense. The infusion was over at 1:30pm and I had to stay another half hour for observation. At 2:00pm the study coordinator took my vitals (temperature, pulse rate and blood pressure) and I went home.

I didn’t feel a thing from this infusion and I haven’t felt any change in symptoms since. My next infusion is January 9 pending confirmation from the study coordinator.

Thanks for listening.
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 12/16/2007 9:14 PM (GMT -7)   
Hi Paul,

Thats great news. I hope it works as well for you as it did for myself and the other people in my UC Abatecept trial group. I have been on the open lable for 6 infusions now.

In my group we found that for UC, it took between 3 and 5 infusions before any results were noticed. Have also found that the drug kicks in like clockwork 14 days after the infusion.

Hang in there and I hope you get great results.
"We are dreamers, shapers, singers and makers..." - Elric, elder Technomage


Scrap Girl
Veteran Member


Date Joined Jan 2007
Total Posts : 653
   Posted 12/16/2007 9:30 PM (GMT -7)   
Paul, glad to hear you are getting the real stuff now. Hope it works for you. Please keep us posted.
Diagnosed with UC in Feb. 2005
 
Colazal (9 a day)
Folic Acid
Biotin
Calcium
Remicade remission


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 12/17/2007 7:53 AM (GMT -7)   
Thanks Severin and Scrap Girl,

Severin, I’m glad it is working for you but I’m not so optimistic. I have been through this before with the Adacolumn Apheresis trial a couple years ago. It was already approved in Japan and Europe with 80% success rate and yet it didn’t work for me. In fact the North American study was so poor that it probably won’t be approved here. I also heard good reports about the Adacolumn working for others. I find it hard to believe that I would have received the placebo in both the Adacolumn and Abatacept trials and also the other subject in the Abatacept trial here would have received the placebo as well. Even if it does work for most, no treatment works for a 100% of subjects. I may sound pessimistic but I am just preparing for the worst. I truly hope it works for me.
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 12/17/2007 10:26 AM (GMT -7)   
After all you've been through, I can understand why you don't want to get your hopes up. That was just awful that you fell on the ice, besides. Hope you have a great holiday with your family & best wishes for 2008! / Old Hat (nearly 30 yrs with left-sided UC ... [etc.])

Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 12/17/2007 8:47 PM (GMT -7)   
Thanks Old Hat, One advantage of slipping on the ice is that for one day afterwards my BMs were half of what they were. I wouldn’t recommend this as a treatment, it last way to short and the pain just isn’t worth it. Lol.
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
 


Horus
Regular Member


Date Joined Feb 2007
Total Posts : 190
   Posted 12/18/2007 4:04 PM (GMT -7)   
Paul L said...
Thanks Severin and Scrap Girl,

Severin, I’m glad it is working for you but I’m not so optimistic. I have been through this before with the Adacolumn Apheresis trial a couple years ago. It was already approved in Japan and Europe with 80% success rate and yet it didn’t work for me. In fact the North American study was so poor that it probably won’t be approved here. I also heard good reports about the Adacolumn working for others. I find it hard to believe that I would have received the placebo in both the Adacolumn and Abatacept trials and also the other subject in the Abatacept trial here would have received the placebo as well. Even if it does work for most, no treatment works for a 100% of subjects. I may sound pessimistic but I am just preparing for the worst. I truly hope it works for me.



I've got to wonder Paul, if you are even considered a "normal" uc patient. You seem to not react well to any of the standard drugs used to keep UC at bay. That right there should indicate something. You don't react well to any 5-asa's, nor remicade, 6mp, flagyl, corticosteroids, and on and on. A typical normal uc patient would react well to some of those. And this would be world wide. People all over the world with uc benefit from these drugs and you do not. I wonder if you are misdiagnosed.

Furthermore, you have C-difficile. Certainly c difficile toxins and their affects on the colon don't respond to any UC meds. How much of your symptoms are UC and how much are from c difficile and can you tell the difference? Perhaps you have more pseudomembranous colitis than actual UC?

Post Edited (Horus) : 12/18/2007 4:07:05 PM (GMT-7)


Paul L
Veteran Member


Date Joined Dec 2005
Total Posts : 647
   Posted 12/18/2007 7:41 PM (GMT -7)   
Horus, being misdiagnosed with UC is always a possibility. That is why I have had a second opinion. My current GI specializes in IBD only. Both GIs are certain I have UC. I had C difficile once from a round of antibiotics I took for another problem. It was cleared up and I was tested negative for it several times since. There was only a difference of a couple of BMs.

I had bad reactions that had nothing to do with UC, to 5ASA based medications. I was tested to see how well I metabolize 6MP and it was shown that it is not an option for me. The same test showed Imuran as well is not an option. This has nothing to do with UC. Corticosteroid enemas probably didn’t work because my UC extends further up my colon than it can reach. Flagyl is not really a mainline treatment for UC. Remicade is the only UC treatment that has not worked for me. Even my rheumatologist wanted me to take it for my arthritis and it didn’t work for that. The only medication that worked is prednisone. I was on it for about 6 months and it worked miracles for one month then the side effects became unbearable.
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
 

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