My Third Abatacept Study Treatment

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,

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.

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.

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.

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.])