Michelle's Experience on an IBD Medication Trial
In honour of IBD awareness week, spanning December 1st to December 7th, I thought I would share my experience of being on an IBD medication trial to treat my Crohn's disease.
The road I found myself at in January of this year is one no one wants to find themselves at: all out of medication options. Which is why I found myself considering to start a phase three medication trial. This drug is something brand new and being studied all around the world. It’s called Filgotinib. It is a biologic like Remicade and Entyvio and yet doesn’t require ongoing infusions. Better yet — it’s a pill, with a new science behind it known as a JAK inhibitor.
Now some people may have their concerns over a medication trial. What are the potential long term side effects? What are the short term side effects? Will I feel okay on this medication? All these thoughts did enter my mind at some point, but I knew I had to give this a try and leave no stone unturned. I have a "you do what you gotta do" kind of attitude when it comes to my health. For me, the most frightening thing was having to quit my Stelara (which at the time was the main drug for my Crohn’s, working alongside Azathioprine). I would have to be off of it for two to three months prior to starting the trial, assuming I qualified. I was concerned about worsening even more while not being on the medication. At that point, I was already getting low grade fevers, stomach pain, frequent bathroom trips, to name a few symptoms. I didn’t want to feel worse.
Starting in February 2021, my gastroenterologist gave me the OK to stop my Stelara injections. This now began the qualification process. This process was very extensive. I had to do colonoscopies, an X-Ray, blood work and send a report on my symptoms every night through an E-diary. All of these were used to assess if I fit the bill to do the trial.
The study is broken down into two main parts. The first part spans about three months. During these three months, the patient is randomized and could be taking either the placebo, the real medication at a high dose or the real medication at a low dose. During this phase, no one on the medical team or the patient knows if they are taking the real medication or the placebo. After the three month period, the patient gets assessed to determine if they will be re-randomized onto the extended blinded study or if they should go on the real medication (not blinded).
In April, I found out I qualified for the study. I started my medication soon after, not knowing if I was on the placebo, high dose or low dose. During that time, I had to go to my specialist’s clinic every other week for study visits. They would do blood work (sometimes as much as 16 tubes) and go over any symptoms I was experiencing. While this part of the study was going on, I was still submitting the E-diaries every evening. I also had to email the team if I experienced any new or worsening symptoms (whether or not it was a Crohn’s symptom). If I took any medications like Tylenol or Gravol, I had to report that to the team. It is quite extensive because they need to monitor how you’re doing and anything you’ve taken. I did find some improvement for a few weeks, but after a certain point I found that my symptoms started to return.
In July, I had a colonoscopy to assess my progress. I also filled out an extensive questionnaire that covered all kinds of topics relating from physical to mental health. The scope, blood work and E-diaries would then help determine which part of the trial I would be put in next.
Shortly after my scope, I found out that there was some improvement but not enough to put me into the extended blind study. I was given the option to start the real medication, at the high dose, unblinded. I accepted, and soon after started the real medication.
At this point, I have now been on the real medication for a little over four months. I go for clinic visits every month. The team still monitors me with blood work and E-diary entries. At this point, it’s hard to determine how well the medication has been working for me. I still have some challenging days and some days that are better. However, because the medication is still being studied, it’s hard to know how long it truly takes to start to work in patients.
When I first got diagnosed, I never imagined being part of a medication trial. But now, I am very pleased to have been part of this process. I have liked having my health so well monitored. My medical team is only a phone call or email away if I had any concerns. Although I have not seen as much improvement as I would hope, at this point I am still hopeful that soon the medication will kick in more and get my disease under control.
Blog post written by: Michelle