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.
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