RHB-104 phase 3 trial.

[lmotsie]

Hello everyone. I am new to this forum, but not new to Crohns disease. I was diagnosed over 10 years ago, after being misdiagnosed with Irritable Bowel Syndrome in my early 20s. I am now 51. I have been on Pentasa, as well as steroids for the past several years. The steroid use has been periodic for particularly bad flares.
I just was enrolled in the Phase 3 study for RHB104. My Crohns is active and my inflammation markers are high. No blood, last colonoscopy only showed inflammation...lots of it! While I cannot say for sure I got the real med, my side effects are saying I did. I know that they put something in the placebo to make your urine orange as to not reveal if you got the placebo. The day I took it, I did not even think of side effects. But on day 2, the nausea hit. Day 3, sleepless nights. I did not even associate these with the RHB-104 until the nausea abated, then flared again after taking my morning dose. I then looked up the side effects of the 3 drugs that make up rhb104 and low and behold, nausea, vomiting and loss of sleep were right up on top. This is good, in that I really do want to try the new drug, but obviously I am hoping those side effects abate and do not become worse as my dose is increased every week.

I can say that on day 4, my number of loose stools has diminished, although I can tell my bowel is still inflamed. However, my most prominent inflammation marker, my red palms, is slightly diminished today. ( My palms look like someone painted red on the pads under my thumb and little finger.)

I have hope for this drug. Really do not want to go back on Humira or any other steroid. Will keep you posted. BTW, my doc said if my inflammation markers do not go down in the next 10 days she is pulling me off the study and I have to go back to more traditional meds. Send me good thoughts in that area please!!

 

[ronroush7]

Welcome. I hope this medicine works for you.

 

[Scipio]

10 days? That doesn't seems very long for your doctor to give the drugs a chance. How long does it take for your inflammation markers to go down when on proven effective drugs such as azathioprine or vedolizumanb?

 

[ronroush7]

Some drugs could take months.

 

[lmotsie]

10 days is indeed a short time...although it will actually be 2 weeks. I should clarify, she wants to see my c-reactive protein levels stop climbing, as they have been for the past few months, despite high doses of Pentasa. I am currently well over the 100 mg/L mark. 6 months a go I was at 50. 10 is normal. If when I go in 10 days from now, my level has not increased, then I stay in the study. If not, then switching my main med will nullify my results for the study.

 

[ronroush7]

Pentasa only hits the surface of the disease

 

[lmotsie]

Pentasa has in the past actually worked quite well for me. I believe that a lot of the difficulty I have had in the past year is tied to the stress of an ugly affair/divorce. I had a major flare up shortly after finding my soon to be ex husband was having an affair with my so-called "good friend". This tied with the passing of my mom shortly before and I had a great mix for a great Crohns party! Not to mention that I did not really take the care I usually do until just very recently.

 

[wombatgirl]

How are you doing Imotsie? I don't qualify for the trial, but I recently tested positive for MAP and I am going to start anti-MAP drugs when I can find a doc who will prescribe (my GI team won't). There's a great MAP support group on FB if you're interested:
https://www.facebook.com/groups/425949470944340/

Hope its working for you! Lucky that you got the real drug!

 

[lmotsie]

Hi Wombat girl! Sorry it took so long to respond...I was on a little vacay. So far so good with the rhb104. Had my 3rd week visit to the research clinic today. Of course, I will not know for sure if I got the real juice or not, but did find out this: 1) My inflammation markers have lowered. I was previously over 110 and now just a bit lower. 2) all of my vitals came in good today, blood pressure, heart, oxygen rate, etc. Prior they were not bad...just not great. As for side effects, the only thing that I have is a bit of queasiness an hour or so after I take the first of any increased dose. This lasts for a day or so, so nothing major. My number of loose bowels has decreased from 7 or 8 a day to 2 or 3. Since I have no other changes in meds, I have to assume that this is working. My urine is RED! I would love to say that this is proof I got the real stuff, but I have heard that they put dye in the placebo to replicate that.

I was also told today that they are extending the trial by another 2 years. They will also be taking new patients. I have hope for this. I am feeling better, but do not know for sure if it is the drug, or if my crohns is just quieting down on its own. I am anxious to know what my blood results show. My gastro, who is part of the study, told me that if she does not see improvement for me in the next few weeks that she is going to take me off the trial and I will have to go on another med. ( I have severe inflammation) I guess if I get to stay in the study then its working.

My next colonoscopy is in a 4 weeks and that should really give me a hint as to how well it is working. I have not had a "good" colonoscopy in the last 2 years.

 

[wombatgirl]

That's excellent news Imotsie. I may have found a doc who will treat MAP, so yay! I also heard they put red in the placebo, but all the other signs sound great.

You should check out NAG (a supplement - assuming you're allowed to take supplements on the trial). It helps with mucosal healing in the gastrointestinal tract. Was used successfully in 1 small study for some kids who were not responding to other treatment. It's not antimicrobial, just nutritional. The study participants took 3000mg a day. I use Jarrows formula which has 700mg per tablet and take 6 a day (I figured since they were kids in the study I'd up the dose, but you could do anything probably ). More info here: http://www.progressivehealth.com/learn-how-n-acetylglucosamine-can-help-crohns.htm

I also take 6 scoops of Lauricidin a day, though I have since found out that has anti-MAP activity (found various research papers and a patent application). But it is also anti-inflammatory and I found it helped heal my intestines. I have taken it at lower doses and it didn't do as much, but I haven't taken it with anti-MAP abx (it wouldn't interfere with them, as its a derivative of lauric acid in coconut oil). Anyway, I have no idea if you're allowed to take supplements on a trial.

Glad there's no major side effects!

 

[Scipio]

If you are participating in a clinical trial you should not start any supplements or other new drugs without the knowledge and permission of your doctor. Otherwise if the supplement works great, or conversely causes bad side effects, then either of those two effects might be falsely attributed to the drug being studied in the trial.

 

[lmotsie]

If you are participating in a clinical trial you should not start any supplements or other new drugs without the knowledge and permission of your doctor. Otherwise if the supplement works great, or conversely causes bad side effects, then either of those two effects might be falsely attributed to the drug being studied in the trial.

You are right. I had to fill out a form for all supplements beyond vitamins that I currently take. Adding any others requires that I inform them, and it could possibly get me kicked out of the study. Therefore I will not add anything during the duration of the study. I am really hopeful that the MAP theory is correct.

 

[lmotsie]

Update. Got blood work results back today. After 4 weeks in the RHB-104 Phase 3 trial I can say that I am showing major improvement. My C-reactive Protein Level, which prior to the start of the study was consistently over 3.5 for the last 2 plus years is now down to 1.34. Still considered high, but much improved. My white blood cell count has also decreased significantly. My red palms have started to fade. Diarrhea has decreased from 5 to 12 times daily to 0 to 2. I have just started the "full dose" (5 pills 2x a day) so I am hoping that it continues. So far no significant side effects. Just minor upset stomach after the increased dose. Hoping this trend continues.

 

[Julia S]

That's great to hear Imotsie! Keep us posted! Do you know when they´ll be releasing an interim report?

 

[aga]

Any news about rhb104?