Clinical trials

Anyone with any experience or thoughts? Thanks!

I was part of a clinical trial for Pravastatin. It is typically used for high cholesterol but they were finding it had anti-inflammatory effects in high doses. I completed the trial and had a definite improvement in symptoms, however I started getting horrible migraines and palpitations towards the end, so I had to stop. Side effects went away very soon after stopping. To be honest, it made me nervous to be taking a drug that is known to have dangerous side effects in lower doses and I was taking a dose much higher than cholesterol patients.

I don't pretend to understand the science but Vedolizumab, or mln0002, is very similar to tysabri. They both are antibodys that stop specific proteins that cause inflammation. The difference with Vedolizumab is that it goes after two proteins where tysabri goes after one protein. Hopefully it gets approval so there is yet another line of treatment for those who may be Out of options.

I'm in the vidolizumab trial right now. I started in the double-blind part in July and then open label in October. My symptoms didn't change at all in the double-blind phase, and I started to have some improvement about 3 months after starting the open label. Unfortunately, my symptoms are not improving anymore, and I had a flare-up of an old closed fistula very recently and I'm still feeling pretty poor. I go in for my next infusion in a couple of weeks and I need to decide if I'm going to continue with this trial or try to get in a trial for a different drug. It's VERY frustrating to think that I've been spending all of this time waiting to get better and it's not going to happen with this drug, and I might have to start from scratch with something new that still might not work.

The other frustrating thing about the clinical trial process is that, while my doctors and nurses are caring, it feels like they're interested more in the drug and the trial than they are about me feeling better. To them it's numbers on a page and I wish they'd see me more as a person than as an experiment.

That said, my doctors said that most people are responding well to this drug, and there haven't been many side effects. I had lots of side effects with remicade and humira but I haven't had any on this drug. I do wish I could do more frequent infusions to see if it would work better, but that's not possible in the trial.