Alysa's Story

Clinical Trial Story
Diane K., a Clinical Trials Ambassador shares her daughter, Alysa’s story.

On her seventh birthday, my daughter Alysa was diagnosed with Crohn's disease. She claims it was her most memorable birthday- she was met with so much love from everyone at CHOA (Children's Healthcare of Atlanta) at the Scottish Rite Hospital. Once she was diagnosed, Alysa was started on a low dose of a biologic and received her infusion every 8 weeks. Slowly but surely, we discovered that 8 weeks was too long between doses, and we bumped infusions to every 6 weeks. It was hard to believe that our little girl, who had been very healthy up to this point in her life, had to receive infusion treatments. Eventually, her doctor at the time increased her dosing to every 4 weeks and prescribed a steroid.  At this point, we knew that what we were doing was not working.

After joining a support group and hearing from other families, we learned changes in medication could be needed when treating IBD. We chose to speak to our doctor and see what other options we had. We ended up finding a new doctor, modifying her diet, and taking note of what Alysa was eating with a daily journal. Alysa started a new biologic just a couple of months after failing the first. This medication required regular injections.  Although it was scary for all parties involved, Alysa showed great bravery and strength.

We tried this treatment for 6 months. Alysa had days where she was feeling better and other days where this medication was just not cutting it and we had to try adding other medications to help eliminate the bleeding. Through all this, she was still not feeling well. It was at this point, we sat as a family and shared our thoughts on what needed to change. Was it diet? Was it something in the environment? Was it stress-related?

In the spring of 2018, our new doctor talked to us about a clinical trial that was enrolling children with Crohn’s disease and ulcerative colitis. We were given reading material, answers to our 1,001 questions, and at no point felt pressured to participate by any medical staff—doctor, nurse, or research nurse. We felt that joining the clinical trial would not hurt. My daughter had failed two other drugs, even with higher doses, and attempted diet modifications.

In order to see if Alysa was a good candidate for the trial, she needed to undergo a colonoscopy and endoscopy (her second one since being diagnosed). We were a little hesitant to have her go under yet again, but understood it was part of the process. She qualified for the clinical trial and we were looking forward to having her start feeling better. Our research nurse was amazing, infusion staff was great, and our doctor, nurse, and research nurse were all so attentive.

No extra work was needed on our part other than medical appointments, bloodwork, and occasional clarification with medical bills as we were initially charged, but thankfully all charges were eventually covered by this research study.

The biological therapy that was tested in this study worked well for Alysa. There were some good days, and other days where were a little tired. Those days were typically close to when she was due for her next infusion. We qualified for the extension of the trial in September 2018, which changed how often Alysa would receive infusion treatments. We were a little nervous about this change because, with other medications in the past, prolonging the time between her doses proved to hurt Alysa more than help her. We noticed that once school started, her immune system seemed weak. She struggled with infections and low energy levels. We knew that immunosuppression was one of the side effects from the medication.

We brought this up to the doctor and research nurse and came to the decision that continuing the study might not be the best option for Alysa. In January 2019, we were taken off the study.  Waiting 8 weeks between infusion treatments was not working for Alysa. Although we were saddened to no longer be a part of this trial, it was a great experience and we will be forever grateful to our medical staff for their continued support and encouragement.

Our recommendation to other families that are possibly looking into whether or not clinical trials will work is: do your research, consult with other families, join a support group, and be open and honest with your medical staff about your questions or concerns. Most importantly, know that you are not alone and that there are plenty of resources out there for you to stay informed.

Hometown: Georgia