Posted 9/17/2007 9:16 PM (GMT -6)
Today I had my first Abatacept infusion in a clinical trial. It has been a long day, or should I say two days. Yesterday I completed the prep for a sigmoidoscopy this morning. I arrived at the hospital at 8:30 am and only took 5 minutes in admitting. That’s a record for me. Usually it takes 30 minutes or more. I then went up to see the study coordinator. I gave her my daily log card for the 3 days before the prep, a form from my family doctor with the results of a TB skin test and I gave her a stool sample I took at home just before I started the prep. I have to provide a stool sample before each treatment. She asked me if I wanted to participate in a pharmacogenetic blood DNA substudy. At my last visit she gave me the consent form to read over. It involves one blood sample that can be kept for up to 25 years. They are looking for genetic differences in people with UC and healthy people and also compare UC patients with different responses to different treatments, including Abatacept from this study. I consented to the substudy and signed the consent form.
She then weighed me, took several vials of blood and I gave a urine sample. At this point I’m not officially in the Abatacept study. I still have to complete the sigmoidoscopy and pass with enough inflammation. At about 9:30 I arrived at the endoscopic room. I was surprised to see that it had been totally renovated. The last time I was there was 6 months ago. It had a new simulated hardwood floor, new counters, cabinets and new paint. It looked great. As I came out of the change room wearing a gown, a young female doctor came up to me and asked if I wanted to participate in another study. They want to compare symptoms of UC patients with actual colonoscopy/sigmoidoscopy and blood results. I signed the form and then filled out a 30 question questionnaire about my symptoms for the last few weeks and my general well being. Wow, 3 studies in one day.
I was then called into the main room where they took my blood pressure and asked me several questions. I then lied down on the stretcher and they wanted to hook up an IV line for sedation. I refused because it is only a sigmoidoscopy. They wheeled me into the procedure room where my GI and study coordinator’s assistant (GI’s wife) were waiting. The actual scope lasted only about 5 minutes. No biopsies were taken. Inflammation and ulcerations were clearly visible for 40cm before it tapered off. The doctor didn’t look any further as that is generally the limit of a sig. That was more than enough to enter the study. The coordinator’s assistant then called the hospitals pharmacy to have them prepare the Abatacept/placebo. I was out of the endoscopic room by 10:30am.
I then went for lunch (I was starving) and back to see the study coordinator at 11:15am. She gave me 4 different study questionnaires with any ware from 20 to 40 questions each. They included everything from my symptoms for the last 2 weeks to how UC affects my job and personal life. Many questions were repeated several times but with different wording. It was very intense and took over 30 minutes to complete. I then had to wait for the drug/placebo to be prepared. At about 12:30 the study coordinator and I went to the infusion room located in the building behind and across the street from the main hospital. There were 5 patents already receiving their Remicade. The study coordinators assistant met us there a half hour later with a second UC patient also just starting the study.
The setup is almost identical to Remicade except they had 4 bags, instead of 2 hanging from the pole. Two were saline and two were the treatment drug. I was told that just like Remicade they would start a saline drip then switch to the treatment drug. The first treatment bag would last for one hour and the second would last for a half hour. Because this is a double blind study they use two bags. This is supposed to make it more difficult to tell what the actual dose is. I could be receiving any one of placebo, 3, 10 or 30/10 mg/kg Abatacept. I have a 29% chance of receiving a placebo. Not even the study coordinators or doctor knows which one I am receiving.
They inserted the IV and started the infusion at about 1:00pm. I tried to get some sleep but it was difficult with all the people coming and going. They checked my temperature and blood pressure every half hour. In the middle of it the study doctor came in to give me a interim physical examination. I was fine and didn’t feel any different. The infusion was over at 2:30pm but I had to wait for another hour for observation. I left at 3:30pm. It was a long day. Next week will be identical but after that the infusions will only be ½ hour with ½ hour observation for a total of 4 infusions over 12 weeks. This is the induction period. It may take several infusions before the drug takes effect if at all.