Loaning My Body to Science Part 2: New Oral Treatment Study

In my last article, I described my experience of going to the National Institutes of Health near Washington, DC to participate in an ongoing comorbidities study on cardiovascular and metabolic disease. It was such a great experience, that I decided to enroll in a local study for a new oral treatment for moderate to severe plaque psoriasis.

Benefits of participating in clinical trials

There are so many reasons why clinical trials are important. For starters, it’s necessary to bring new treatment options to the market. The FDA requires all drugs to prove their safety and efficacy and that can’t be done without trying it out on patients. This may sound scary, but there are three phases to clinical trials, and patients aren’t introduced until the last phase. By this point, researchers have a good grasp on the expected side effects.

Along these same lines, another benefit of clinical trials is that you are monitored VERY closely by a certified dermatologist and his/her team. They don’t just give you the medicine and send you on your merry way. You get labwork, x-rays, and routine visits (more than you would with your regular provider). There is even an extensive screening process to make sure you are a good match for the study.

The best part of all of this is that it is completely free. In fact, the study I am reimburses me a small amount for my travel and time. This makes it a great option for those like me that are uninsured. I am able to have access to cutting edge treatment that I wouldn’t have been able to afford on my own.

The washout - potentially getting the placebo drug

I’m just starting this study, so I don’t yet know if I am getting the new medication, Otezla (the medication it is being tested against for efficacy) or the placebo. I feel like it will be pretty easy to figure out since I will either continue to be covered in plaques, will crap my pants (I’ve heard this is very common with Otezla) or start seeing clearing of my plaques. That is one of the drawbacks that almost kept me from going into this trial—I may have to go up to three months without treatment if I am on the placebo. But in my situation, it’s worth it because I am guaranteed to get on the new medication after that.

Keeping a diary during the clinical trial

Another part of this study is that I have to fill out an electronic diary each day rating how my psoriasis is doing. I was given a device that looks like a cell phone to use for this. It only takes about two minutes to go through the ratings of my flaking, redness, itchiness, cracking and stinging on a one to ten scale. The only hard part I have found so far is that it must be done at the same time each day. My schedule is a little nuts between work, taking care of the kids and whatever else the day throws at me, so it has taken discipline to remember and not snooze my daily alarm.

My motivation to participate in clinical trials

Up until this point, there have not been many oral medications that can stand up to the success of injectable biologics. I originally wanted to do a trial for an injectable (despite my fear of needles), but I have failed so many of the new treatments that there weren’t any studies currently enrolling that I was eligible for. Despite that, I am actually excited to be in this study. There are many psoriasis sufferers that can’t take injectable or intravenous infusions for one reason or another, so being able to have another oral treatment available would be a great thing.

I hope that I have been able to shed some light on clinical trials and inspire those of you that have been on the fence about it. If you are healthy and able-bodied, I would encourage you to do more research and see if it is the right fit for you. Researchers need us, and the community needs more options. It’s a win-win situation.