Started on Ozanimod clinical drug trial - Really suffering

Hi everyone

After a fairly good period of minimum symptoms on Entyvio (7 years) it stopped working for me in Oct 2016.

I have exhausted all other drugs so I have almost no options left open to me now.

I enrolled on the Ozanimod drug trial at my hospital, I had to sit out a 4 month Entyvio washout period, stop the Azathioprine and all rectal meds, keep the pred below 20mg (I am currently on 10mg) and undergo a load of pre screening tests & colonoscopy, which took over a month to complete.

I am now one week into the trial and am taking 1mg Ozanimod tablets daily. I have not seen any improvement at all. In fact, things are getting horrendously worse. Blood is increasing every day, pain is unbearable, going between 10 and 15 times a day and night with severe urgency. Things are so miserable its unreal. I am in a really bad way.

I am fairly certain that I am on the placebo. Surely, things would not be going backwards like this otherwise.

I am so disappointed and demoralised. I am not even allowed to increase my steroids, or make any other changes to my meds on the trial (apart from decrease the pred!!). I am in a terrible situation.

I have to get to week 10 before I can enter the open label group and get the real drug for sure as a non-responder in group 1. But, the way things are going, its a tall order getting to that stage. I really hope that I am not going to be forced to drop out of the trial. I had to jump through hoops to get on this trial and practically put my life on hold for 5 months to do so.

It really sucks that I have severe active UC and am so unwell, and I am sent home with placebo with virtually no meds to treat my horrific symptoms.

I'd dropout

Since you are suffering then I would drop out. I would hope that your GI would agree.

I see that you are in London. How about Cyclosporine? I am very happy with my j-pouch, it's not perfect but I don't suffer any longer.

I have chronic pouchitis; it is soooooo much better than having UC. I had very aggressive UC/CD too; my pouchitis responds well to medications. I use the term CD now because I have chronic pouchitis, whether it is CD or UC is up for debate. about 7-10% of j-pouch patients have chronic pouchitis.

Have you thought about antibiotics to treat the UC? It's not conventional but may be a way to treat it while staying on the Trial.

So sorry! I know how miserable this stoopid disease can be. Isn't there any way your doctor can speak to the drug trial about the emergency medical state you're in or about to be in? Maybe they can get you in the open trial sooner? I'd try it, at least.

Can I ask what your diet currently consists of?

Usually you don't want to change or try too many things at once because you never know what is working then. But in dire situations sometimes you just have to throw the whole kitchen sink at it. Maybe try modifying your diet to something many people have had success with while you're on the trial. SCD, GAPS, paleo, etc. It could ease your situation and let you stay on course.