Medically reviewed by Jenny Blair, MD
My journey with Crohn’s disease has been an arduous one, laden with difficult decisions, including whether to take strong medications and when to have life-altering surgeries. At one point, Crohn’s derailed my career, my prospects of finishing graduate school and my ability to pursue meaningful relationships. But I was scared to try any new medication, let alone partake in a clinical trial. I was young and didn’t want to be burdened by a strict drug regimen or potential side effects.
After I had more than 20 corrective surgeries in a seven-year period, my doctor at the Mayo Clinic asked me to consider a medication still in clinical trials. It wasn’t an easy decision, but at the same time, it seemed like a no-brainer. I had a new rectovaginal fistula—even though my rectum had been excised—and I was out of medical options. My Crohn’s was continuing its spread, despite the problematic organs having been removed. It was a phenomenon my gastroenterologist told me he had only seen a couple times before. I was hopeful for a chance at life again, though, and if that meant joining a clinical trial, I was on board.
Enrolling in a Clinical Trial
Most cases of inflammatory bowel disease (IBD) aren’t so extreme—and don’t have to be—in order to get into a clinical trial. This gives patients with differing levels of disease severity a chance to partake in the latest trials. In some trials, surgeries are an exclusionary factor, as altered intestines can complicate the results.
As for enrollment, the process for me was fairly simple. My doctor handled the paperwork. And because the medication had already been FDA-approved for other autoimmune conditions, my gastroenterologist was able to request a prior authorization from my insurance company—but for a much higher dose. For medications that haven’t been approved for any other conditions, trials are often free of charge for the patient.
My Clinical Trial Experience
I started the medication six weeks after my last surgery and was put on antibiotics and an immunomodulator to ease my fistula symptoms while the new drug was given time to work. Then came the more grueling process of visiting my local doctor’s office every single week for general monitoring, which included testing, addressing side effects and receiving iron infusions for anemia.
During this time, I reported nerve pain and was referred to a neurologist for electromyography (EMG), which helps gauge the health of your muscles and nerves. My gastroenterologist ended up reporting nerve pain as a potential side effect of the clinical trial to the FDA. I also experienced fungal infections, for which I was treated by an infectious disease specialist.
As difficult as the adjustment was, I was fortunate to be steadily monitored to ensure a smooth transition from surgery to this new medication. After three months, an ileoscopy and magnetic resonance enterography (MRE) were done to look at my small intestine and see how it was responding to the drug. At that point, I learned that my fistula had closed and I was heading into clinical remission.
As time went on, my doctor’s visits went from weekly to biweekly to finally monthly, which is where I stand now, more than four years later. I have ileoscopies once or twice a year and MREs twice a year to ensure no new fistula development.
The trial itself ended a year after I had joined and resulted in FDA approval. The approval added loading doses for new patients, but I continued on the medication as I had done before.
What I Would Have Done Differently
Now, after 14 years of living with IBD, I can truthfully say I wish I considered a clinical trial sooner. I had been offered this same medication in a clinical trial at a different dose four years earlier, but I refused because I was afraid of the lack of data. And therein lies the conundrum. Many patients, myself included, veer away from clinical trials due to the lack of evidence of their ability to treat Crohn’s or ulcerative colitis.
But the truth is that the biologics and small-molecule medications currently available do not work for everybody. What about the remaining population of IBD patients who may not respond to the existing arsenal of drug treatments? That’s where this clinical trial came in for me. The trial gave me hope for the future—a future where my Crohn’s is better managed and isn’t as burdensome.
Hindsight is always 20/20. I can’t go back and change what I know now versus what I knew then. But what I’ve learned over the years is priceless, and if I had to enroll in another clinical trial down the line, I would be far more inclined to do so.