[RedHill RHB-104 Trial] - Anyone here participating?

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Hi Endrwign

I was wondering g the same thing I expressed interest to my GI about this trial in January before I began remicade and he said the hospital had applied to become a part of the trial but never heard anything back. Hopefully its going well for participants.
 
rhb 104 uses drug combination under license from work done by prof tom borody and prof herman-taylor

this recent thread on the forum should be of interest to anyone who wanted to get on the rhb 104 trial as the treatment is possible in UK USA and Oz if you can find someone in the healthcare profession who is willing to treat you with the anti-MAP combo.

http://www.crohnsforum.com/showthread.php?t=69505
 
RedHill put out this press release with some updates on their RHB-104 trial. Even though the trial is ongoing, it seems there are at least enough positive signals to keep it moving along.

Highlights:

* Starting a new trial this summer to specifically assess clinical utility of diagnostic test.
* Will expand their current phase III trial of the actual drug to include patients currently on biologicals.

http://www.redhillbio.com/wp-conten...for-Crohns-Disease-Following-FDA-Meeting-.pdf
 
I would definitely do this if there wasn't a 50% chance I'd be on placebo. Since it's already in phase 3, I wonder how long it will take to get to market. Probably not much longer.
 
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Shoot, it'd probably be worth signing up just to get tested with the new diagnostics test they're talking about. And now that they will start accepting subjects on biologic treatments, what's there to lose, even if you do get the placebo? You'll come out the other end knowing for sure if you have MAP infection or not.
 
xeridea said:
Shoot, it'd probably be worth signing up just to get tested with the new diagnostics test they're talking about. And now that they will start accepting subjects on biologic treatments, what's there to lose, even if you do get the placebo? You'll come out the other end knowing for sure if you have MAP infection or not.
Click to expand...
If I get placebo how will I ever know if I have MAP infection? The only way to truly know is if I 1) get the actual medication and 2) it works. I also live in Naples, and I'd have to drive 2 and a half hours all the way back to Tampa every Friday to participate in the study in the beginning. So it would be very time consuming. It's something I'm thinking about though.

The lady did not mention anything about the diagnostic test.
 
I am in the early stages of entering the RHB-104 clinical trial and will be meeting with a study doctor in a few weeks. After reviewing the 25 page "Informed Consent Form and HIPPA Authorization" and other research into this project, it appears to be fairly safe and should advance my understanding of my Crohn's Disease. My Crohn's activity is in the ileum again where I had an emergency resection 16 years ago.
In the initial screening, they seemed to be concerned whether I had "obstructive episodes" or not. Probably because you won't know for over a year if you are on placebo or not. And if you are having serious obstructive episodes or other serious issues, my guess is that they are concerned for your safety going forward. I'm sure they also want reasonable assurance that you can follow through the full course of the trial. Keep in mind that you can stay on most current prescribed treatments and recently included some biologics. My current treatment is 4g /day Pentasa that I will continue if accepted in the trial.
Would appreciate hearing from anyone else in this study and will update my progress here as well. As far as MAP testing, I think they are testing the participants but my understanding is that the MAP test is not officially part of the trial yet. Maybe it will have it's own clinical trial program? I do know they will be taking multiple blood and stool samples throughout the trial participation that they have the rights to keep for 10 years.
 
Hi
I am not participating in the trial but I have been using anti map treatment the last three months. I went to see Doctor Sanderson in London and have been taking the treatment along with humira every two weeks and imuran 100mg daily. I have had previous operations for strictures and had resections leaving me with about 160cm small intestine and about a metre of large intestine. My small intestine was only originally 2metres so I never had that much to begin with. My disease for the last twenty years was only ever ileitis and after doing absorb plus,oregano oil,DMSO protocol for six weeks and then the SCD DIET for nine months spread to my large intestine. I made all these efforts so I could get pregnant without medication. Needless to say this exploded in my face big time. I was sick to be honest the whole time I did SCD and I obeyed it to the letter in fact I had a much stricter diet with basically protein,gelatin,pureed apples and squash. At about four months pregnant I was hospitalised and fed through an ng tube and given hydrocortisone as I had stopped eating and my Crohns was very bad. A couple of weeks later I had to stop the ng feeding go back to hospital and have a 20cm stricture removed and an temporary ileostomy. My Crohns went into to remission with the bag and I was really well until the baby kicked out my insides and my bag was reversed and my baby was sectioned. A small part of my large and small intestine was removed again from the prolapsed stoma. By some miracle my baby is perfect. My Crohns returned and I was on infliximab imuran and then changed to humira because of psoriasis from infliximab. I don't consume dairy or give it to my baby for fear of crohns. I really hoped the anti map would work for me but sadly after three months on it I ended up in hospital with an obstruction. It felt like it was doing something in the beginning and I was eating more foods that I hadn't been previously but then I flared and stopped eating the fibre. Unfortunately I continued to get flares every week until the flare turned into four days of non stop pain and vomiting that brought me to the emergency room. I'm sorry for the big explanation but I just wanted to give you all the facts about my Crohns because maybe anti map wasn't as effective because of my shorter bowel or because I have stricturing Crohns but I would encourage everyone to try it and see if it works. I would say that if you try SCD and you dont see results stop it because it done me more harm. I am currently waiting g for my Crohns to calm down before I can have a colonoscopy to see if I need a stricturplasty or can get away with a baloon dilation.
 
If your stricture is on your left colon, maybe rectal mesalazine can help. I have the same type of crohn's and mesalazine (both oral and rectal) helps me; although not too much.
I have used oregano oil for around 10 days and it caused me to flare and narrowing of my colon. I'm still in that flare.
Since you are lactating you don't have too much medicine option.

SCD wasn't helpful to me. After the fail of SCD I did an elimination diet to see which foods I can tolerate and which foods I can't. It helped a lot. I suggest an elimination diet, also look for autoimmune paleo diet. There are other good diets like GAPS, paleo, perfect health diet. The key is eating real food and low carb. Also gluten free, casein free etc...
 
Hi Crohns 2357
Sorry my baby is two now and my Crohns has been been pretty unpredictable since moving to my colon or maybe because of resections. After 22 years of this disease I have pretty much tried everything in terms of diets. Gluten dairy free worked for me when I had Crohns confined to my ileum and took imuran but I didn't think that would be enough when I came off my imuran which is why I done six weeks of Absorb plus and then SCD. I have stayed off dairy because of MAP but gluten free doesn't work for me anymore to be honest nothing is. I am on humira weekly imuran 100mg daily and 35mg steroids reducing. I have decided to stop eating and drink fortisips to see if that will make a difference. Otherwise its on to Stelara. Fortisips are whey based but have no lactose or gluten and are sterilised but are hard on your insides. I have done elemental and semi elemental drinks but studies have shown there is no difference between them and polymeric and I have lost a lot of muscle mass with elemental drinks which has so been shown in studies. I am happy to stay on these drinks for the majority of the time rather then have anymore small intestine removed. I'm determined not to lose anymore and live healthy for my child.
 
EN drinks make my condition much worse. Either sugar, casein or combination of both in them; not sure which makes me so much worse.
There are other options you can try. Like cannabis. You can make your own cannabutter very easily. It is very effective and much safer.
Like you said, you can try Stelara. Also Entyvio, methotrexate. Combination of some of these...
 
Hi Crohns 2357
I have tried smoking cannabis before for stricture pain but didn't find it very effective. I meant to say in my previous post I was on pentasa for years and mezavant for a short time but both done nothing for me. I would like to get involved in the qu biologics trial but you have to be off biologics so I suppose it's not really an option. I'm just thinking adherent invasive e coli might be my problem as anti map medication apparently is pretty ineffective against it and can make it worse. If I have to take Stelara I will I just don't want to be eliminating my options. I have always found when I have taken any of these drinks my diarrhoea is still bad and I don't think I tolerate casein well either but when I finish the course and start eating I'm well so they do work for me. Thanks for your advice though.
 
Hi Nosebag. Smoking isn't an effective way to treat crohn's. You'd get much more benefit from ingesting cannabis.
For stricture I use hydrocortisone enema every night for some time. Additionally, I use mesalazine enema and salofalk granules every morning.
Maybe sulfasalazine can help you. Pentasa isn't effective for colonic crohn's.
If I were you, I'd add sulfasalazine or asacol, mesalazine enema to my daily regimen. They are really the least toxic drugs for crohn's. I would also add hydrocortisone enema; but I don't know where is your crohn's stricture located. If it is on your left colon, sigmoid colon, rectum... than rectal meds can help greatly. If it isn't, then they wouldn't help. Hydrocortisone enema does have much less systemic effect than prednisone tablets. I would also make my own cannabutter and take it daily. These can help you.
As for Anti-Map therapy, most doctors can't use clofazimine because it is not available; but I've read that it is the most important antibiotic among the other anti map antibiotics. It is needed to achieve a greater success.
 
Hi Crohns 2357
I was on clofazamine it actually wasn't that hard to get in Ireland but I was waiting a month for it. My stricture is at the end of my small intestine where my previous resections have been. I don't have any strictures in my large intestine that I am aware of but we will see when my bowels settle and I get my colonoscopy but I think it's just ulcers and inflammation. I cannot tolerate sulfazalamine(wrong spelling) and I took pentasa when my Crohns was only in my ileum and mezavant when it moved to my large but the drugs are too mild and have no effect on my Crohns. Maybe ingesting the cannabis instead.
 
Redhill's stock has sort of shot up about 40% in the past few weeks. I haven't heard anything that would explain this. But am hoping maybe there's some whisper of positive trends in the RHB-104 trial. I realize they do have other drugs in various trial stages too, so it can be nothing related to their CD trial.

But I can hope!
 
xeridea said:
Redhill's stock has sort of shot up about 40% in the past few weeks. I haven't heard anything that would explain this. But am hoping maybe there's some whisper of positive trends in the RHB-104 trial. I realize they do have other drugs in various trial stages too, so it can be nothing related to their CD trial.

But I can hope!
Click to expand...

I agree - I am anxiously waiting for the results! I mean just think about it, if it does well, and eventually goes to market and is an option for treatment, that is HUGE! Especially since they are developing a diagnostic test. Definitely something to look forward to toward the end of the year!
 
Just saw this today:

RHB-104 - Crohn’s disease (Phase III) and multiple sclerosis (Phase IIa)

Crohn’s disease - first Phase III study ongoing

Approximately 200 subjects out of the planned total of 270 have been enrolled to date in the randomized, double-blind, placebo-controlled first Phase III study with RHB-104 for Crohn’s disease (the MAP US study).

Interim data and safety monitoring board (DSMB) analysis is on track to take place in the fourth quarter of 2016 and RedHill remains blinded to the interim and ongoing results.

RedHill is currently reviewing a possible amendment to the Phase III MAP US study protocol intended to further enhance the overall robustness of the study, provide a more precise assessment of RHB-104’s treatment effect, collect additional endoscopic mucosal healing data, further evaluate the Crohn’s disease population enrolled and address retention and early terminations. No changes are planned to the primary endpoint of remission at week 26 or the study’s 90% power. Taking into account a potential protocol amendment, completion of recruitment is expected in 2017 with no anticipated material impact on the Company’s overall cash burn rate through the end of 2017. The Company expects to provide further details in the coming weeks, once plans are finalized.

And the MAP vaccine human trials were also postponed....this is not good:-( I was hoping to see the results this year...
 

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