The day is quickly approaching (Tuesday) where I begin my clinical trials. As such, I thought it would be a good idea to create a series or thread specifically for the clinical trial where I talk abut my experience. I think it would be important because a) this is very likely a drug that will be on the market in the next 5 or so years for people with IBD since it is in the third phase of trials and b) some people may be interested in clinical trials but have no idea what to expect and this could give them some insight.
So here we are.
So let’s get to the basics
Biotech company: Abbvie
How does it work: this drug is a JAK1 selective inhibitor, or a Janus kinase 1 inhibitor. We have 3 JAK’s. The drug works by binding to JAK proteins known as cytokines. JAK proteins when activated transmit a signal inside the cell to initiate proliferation and maturation of immune cells, which increases inflammation. By binding to these proteins, JAKs are unable to complete this process.
The drug is administered orally and currently there are 5 different doses (0 mg-placebo, 7.5 mg, 15 mg, 30 mg, 45 mg).
Patients screened for the study are known to have moderate to severe active UC (a score of 5-9 on the Adapted Mayo score) and an endoscopic score of 2 or 3. They have tried other biologics and treatments and were unresponsive.
I had to complete a 35 day screening period to make sure I met the study requirements. This included:
- Medical/surgical history
- Physical exam
- Vital signs
- Blood draw (assessment of blood cells, chemistry, inflammation, HIV, Hepatitis B and C, and pregnancy
- Urine test
- TB test
- Review of current medications
- Colonoscopy and biopsy
- Chest x-ray
- Stool sample for C.Diff
- Set up with electronic diary
We had to make sure I was off Remicade for a certain period of time before I started the drug and I was pulled off methotrexate as well. We were able to keep me at 20 mg of Prednisone in the mean time since I had already showed signs of new inflammation after going down to 10 mg of prednisone only in a month.
So Tuesday is the grand day where I will officially begin, so my baseline visit. After this I will have to go back week 2, 4, 6 and finally on the 8th week. This brings us the to end of the first phase of the 8 weeks. After these 8 weeks you are administered the therapeutic dose of the drug and then monitored from there. I do have to complete another colonoscopy on the 8th week, but the prep they gave me was actually the easiest one I have ever completed in my life. It’s called Purg-Odan. Seriously guys. It was a cake walk. You only drink 2 glasses of this stuff and then have to drink the rest of the 3L they usually recommend in other liquids (water, juice, tea, etc) after drinking it and the stuff actually does not taste terrible. I am going to ask to get this stuff every time.
I was a little hesitant I will not lie. But you are under such intensive care. Every 2 weeks you have to do blood work, a physical exam, vital signs, stool sample, a urine test, and a questionnaire to see how your symptoms are. The minute you start showing signs of getting worse you have the right to be pulled from the first 8 week trial an moved into the therapeutic dose. Your doctor would be told what your initial dosing actually was (it’s a double-blind study, meaning your doctor does not know what dose you are being given at the beginning) and then you proceed however best is suited for your case. My doctor even gave me his personal cellphone number incase anything serious happens and you have a whole research team working with you as well.
But we will find out. So if you wanna follow along look for this series and see where this adventure takes me!
Until next time,