Important new low side effect treatment option in clinical trial you may be eligible for (or help others learn about)

Crohn's Disease Forum

Help Support Crohn's Disease Forum:

I'll let you know what my GI says because I'm going to ask can I get the laboratory tests for this trial done through the hospital I attend. I'm currently on Imuran and Remicade and think anything is worth taking a chance on rather then these crappy meds. The last time I was actually at one of my appointments the doctor said that in fifteen years there will be much better treatment for Crohns and they will be laughing at the meds they used to use.
 
It's only for moderate to severe?! What are the criteria for these categories...i don't have D, just abd pain and some inflammation in the TI. :/
 
Sea Star, if you're interested in the trial, my suggestion would be to contact Qu Biologics and they can't give you better insight as to whether or not you qualify.
 
I think that qualifies as moderate Crohns, Sea_Star.

I didn't have diarrhea but did experience pain and inflammation, I was still accepted.

As of last friday I am finished my 16 weeks of injections, still feeling amazing in comparison to the start of this year!

So glad I signed up for this! At the beginning of this year my life was starting to go down the crapper... my crohns had returned in full swing, I lost my job because I was too sick to work, and my GI misdiagnosed my c.diff infection and sent me for surgery to get my terminal ileum removed.

I started to research alternative options online and found the Qu Biologics trial. I signed up and they discovered my c.diff, helped me get that resolved, then flew me out to Vancouver to start treatment. Luck was on my side as I was not in the placebo group and started to feel relief from my symptoms after only 3 weeks.

On my 2nd trip to Vancouver my health was amazing, I lucked out again and found a job opening doing my dream job of video game development. The interview went well, I got the job and moved to Vancouver a month later :)

If anyone is on the fence about this treatment and wants to chat feel free to PM me for my contact info, or if you need any help/support in Vancouver when you're here for treatment let me know, I would be happy to assist!
 
I tried to get my son in the trial but he has not been diagnosed with Crohn's for 6 months. Now he has a fistula, does anybody know if this treatment helps heal these really creepy things? I was told the antiMAP antibiotics will, but he cannot participate in the Redhill trial because the FDA considers fistulas a separate disease. I have been considering finding a doctor to start him on antiMAP, but if fistulas can be healed through this treatment I would so prefer that to him taking a ton of antibiotics for years. We just need to wait for the 6th month mark.
 
Mommabear said:
I tried to get my son in the trial but he has not been diagnosed with Crohn's for 6 months. Now he has a fistula, does anybody know if this treatment helps heal these really creepy things? I was told the antiMAP antibiotics will, but he cannot participate in the Redhill trial because the FDA considers fistulas a separate disease. I have been considering finding a doctor to start him on antiMAP, but if fistulas can be healed through this treatment I would so prefer that to him taking a ton of antibiotics for years. We just need to wait for the 6th month mark.
Click to expand...

I had either a draining abscess or fistula for almost a year. It healed about 6-ish months before the trial but the scar has totally changed during my treatment (disappeared almost, seemed to finally fully heal) and I also had skin-tags that are associated with Crohn's and are in the same general vicinity and they have all but vanished.

Can't say one way or another for certain if it was the SSI but I certainly feel it was as all this only happened after I was on the active treatment.
 
I am so very excited about SSI! Not currently flaring, so can't get into the trial. But so hopeful that one day I might be able to swap out my maintenance med for an SSI induced remission!
 
InkyStinky said:
I am so very excited about SSI! Not currently flaring, so can't get into the trial. But so hopeful that one day I might be able to swap out my maintenance med for an SSI induced remission!
Click to expand...

That's one of the things that excites me about the SSI. If it becomes a new first response drug it can, hopefully, head off a lot of problems for a lot of newbies and get a bunch of us off our current pharmaceuticals.

A friend sent me a photo of a Qu Crohn's Trial add on the Skytrain (subway). Still short a pile of folks to complete this phase.
 
Hi guys. I talked to Audrey the day after I applied online for the trial. It took only a few days to get my medical records, but my passport application was a little more complicated. I only had a copy of my birth certificate, so thought I would have to send away to LA and have to wait a few more weeks. But as it turns out, my mom had the real thing in a lock-box. Now I can start the trial process as soon as my passport arrives. Should be a couple weeks! I can't wait to go!
 
I finished treatment at week 16, it's now week 20. I'm still in remission, as long as I keep a good diet.

These days straying from a healthy diet gives me symptoms within a day, which is helping me identify which foods are problematic more easily. While on remicade I had to eat more 'bad' foods to get flare up symptoms.

Seems like dairy and gluten are a big issue for me, when I avoid those I don't get diarrhea or cramping. I've also eliminated 'ruminants' to avoid exposure to MAP.
 
I got c.diff from a colonoscopy at the end of last year, it went undiagnosed for a while and messed up my terminal ileum so my gastro scheduled a resection for February 2014. According to my gastro, surgery was necessary and he didn't think the qu trial was worth trying. He warned me that if I put off the surgery I could get a ruptured bowel and die. I went against his advice and flew out for the qu treatment after finding it online and learning that it had no reported side effects. During the treatment, I developed some painful stricturing at the ileum which eventually resolved itself after I reduced my fiber intake for a few weeks.
 
bees said:
I got c.diff from a colonoscopy at the end of last year, it went undiagnosed for a while and messed up my terminal ileum so my gastro scheduled a resection for February 2014. According to my gastro, surgery was necessary and he didn't think the qu trial was worth trying. He warned me that if I put off the surgery I could get a ruptured bowel and die. I went against his advice and flew out for the qu treatment after finding it online and learning that it had no reported side effects. During the treatment, I developed some painful stricturing at the ileum which eventually resolved itself after I reduced my fiber intake for a few weeks.
Click to expand...
wow so it seems like you were in pretty bad shape. What does your diet look like now? Chicken and fish?

I didn't even know getting cdiff because of a colonoscopy was possible.
 
I just learned the Remicade and 6MP I've been taking for the last couple years are not working, so my doctor wants to discuss trying Entyvio next. I was just reading that forum to see how it's worked for people here, and learned about this trial. I will bring it up with her at my next appointment. I anticipate she won't be keen on it, because she is part of a research institution, and has her own very strong opinions. But after reading about people's experiences on this vs. Entyvio, this seems much more encouraging. I have a fistula and stricturing, and want this fistula healed already!! Besides, I've always wanted to check out Vancouver! Well, my hopes aren't too high she'll okay this right away. Maybe after she's exhausted all the other meds she wants me to try. When i asked her about FMT, she said she recommends it only after they can figure out nothing else that will work.
 
bees said:
I finished treatment at week 16, it's now week 20. I'm still in remission, as long as I keep a good diet.

These days straying from a healthy diet gives me symptoms within a day, which is helping me identify which foods are problematic more easily. While on remicade I had to eat more 'bad' foods to get flare up symptoms.

Seems like dairy and gluten are a big issue for me, when I avoid those I don't get diarrhea or cramping. I've also eliminated 'ruminants' to avoid exposure to MAP.
Click to expand...

thats great news BEES. when did you start your elimination diet? How do we know if its the treatment your receiving or the elimination diet that has improuved your condition? seems a few people do some nutrition treatment along with medical treatment trial. It does bring a bias to the experiement imo, but I understand your position and cant blame the patients for doing best they can, I'd do the same.
 
I filled out the form and talked to the nurse today! I've decided I'm going to go for it!

The only obstacle (which happens to be a pun) for me is I have some stricturing, and the nurse says stricturing is one of the things that disqualifies you. But she said it depends on the level of stricturing, so the only way to know if I'm disqualified is to send in my records and have their doctor evaluate it. That would be disappointing.
 
I was waiting for my passport, but that was pretty fast, just over three weeks. I called on the 16th. Now the nurse can't call until the 30th or something?

I've been waiting about six months for any crohn's treatment because there was a mix-up switching GI docs, so I'm just sick of being sick. That's not Q's fault. I just want to go in some direction soon!
 
David said:
Good luck aloe! Please let us know what they say.
Click to expand...

Thank you David! Finally got my records sent in, and talked to the nurse. It sounds like I have a chance, so just waiting to see. If I start it might be awhile though, because I'm still on Remicade. It hasn't been working, but my doctor wants to wait until I have something to switch to before I go off it. We were thinking about Entyvio next, but apparently it takes a couple months for insurance to approve it, and I'll be switching insurance companies in Jan. because of Obamacare, so everything is up in the air for me for insurance. She said I should wait until things are settled and I have my new insurance before we apply for Entyvio. Meanwhile, she added methotrexate injections for my treatment.

So I've sent in my records and if I can qualify for the trial, I'll see if my doctor is okay with me going off Remicade and trying the Trial before switching to Entyvio. It all seems a little dicey to me though at this point, because I'm worried my doctor won't support me in this. She's very good, but opinionated. If she's not into it, I might lose her support, and I'll need her probably after the trial is over.

Can anyone share experience about what it was like getting their doctor on board with this?
 
aloe said:
Thank you David! Finally got my records sent in, and talked to the nurse. It sounds like I have a chance, so just waiting to see. If I start it might be awhile though, because I'm still on Remicade. It hasn't been working, but my doctor wants to wait until I have something to switch to before I go off it. We were thinking about Entyvio next, but apparently it takes a couple months for insurance to approve it, and I'll be switching insurance companies in Jan. because of Obamacare, so everything is up in the air for me for insurance. She said I should wait until things are settled and I have my new insurance before we apply for Entyvio. Meanwhile, she added methotrexate injections for my treatment.

So I've sent in my records and if I can qualify for the trial, I'll see if my doctor is okay with me going off Remicade and trying the Trial before switching to Entyvio. It all seems a little dicey to me though at this point, because I'm worried my doctor won't support me in this. She's very good, but opinionated. If she's not into it, I might lose her support, and I'll need her probably after the trial is over.

Can anyone share experience about what it was like getting their doctor on board with this?
Click to expand...

My dr was never on board. I did this on my own. I was not on any medications though, so it was way easier for me to go around him. However, I will say that even though his attitude was very negative towards the whole thing, after seeing my labs and all the improvements that I made he was much more interested.
Good Luck! I hope you get in. I'm jealous I wish I didn't have to stop taking it!
 
Hi David :) I met with my GI guy last week. My labs actually looked pretty good from October (fecal cal: 440 c-reactive: 1.26) so we decided to start with 5ASA's instead of pulling out the big guns yet. I'm still feeling pretty crappy but am hopeful that the SSI was enough to downgrade to a lesser med at this point. I'll be have a scope in a few months to see what's really going on in there. For now we wait and see.
Thanks for asking! I'm still working on plotting all my labs. I'll get to it at some point soon.
 
Normally I'd be concerned about you just being on 5ASA but I understand you're in unchartered territory. Please keep us updated as to how you're doing :)
 
Nothing to report from me, still in remission since April/May thanks to this treatment and diet changes.

Happy Birthday David :)
 
@David I want to thank you for posting this. We are in the process of filling out the paperwork for the clinical trial and at this point it looks like my son is qualified. He sent in the survey and talked to the study nurse, so we'll see if he gets in.

He is 21 and is currently on Imuran 150mg + now added Entocort but we can't seem to keep things at bay.

I can keep you guys posted on what happens, but just wanted to say thanks again for getting the word out. What they're doing with SSIs is very impressive and I hope we get in!
 
David said:
For the record, I have reached out to a few people who were in the compassionate use trial like Colleen. I hope others will chime in with their experiences as well.
Click to expand...

Hi David,

SSI sounds very promising. I filled out their online application today. I can't imagine they will take me into their study, since I live so far away in FL. However, it would be terrific!!!!

jayann
 
I posted a ways back that I was thinking about doing this if I was eligible, and wanted to update you on what happened. I talked to the nurse a few times, and explained my situation, and she encouraged me to send in my medical records. I did that, they were reviewed, and they told me it was likely I could qualify. I have stricturing and a fistula, but not really another other symptoms, but still they were saying it might be possible.

My doctor was ready to have me try Entyvio (Remicade, 6mp, and everything else has failed). So I decided to try Entyvio first. Now I'm through 3 months of that, and it has failed too.

I got back in touch with Qu and the person I was working with before has left, and the new person said with my situation I'm definitely not eligible because of the stricturing and fistula, and lack of other symptoms would also be a disadvantage.

So, all that for nothing. A little frustrating they didn't tell me that earlier so I could save some effort, but oh well.
 
aloe Maybe don't give up on the Entyvio so fast. If you failed Remicade after awhile like me it will likely take more than the basic every 8 weeks with ENTYVIO, just not enough med to overcome what is likely a more powerful response after beating up n the REMICADE.
We added MTX 1 ml SC 1x/w and about 6 weeks later the nflammation decreased quite noticeably on scope. Was able to decrease Pred from 40 down to 10.
Eventually we went to every 4 weeks for Entyvio and now the fistula has closed and my ESR is down to 9!
Hate giving up on any drug without giving it every possible chance to work.
Besides what other choices do we have?
 
Thanks Robrich. I would stay on Entyvio if my doctor says it's okay, and insurance will keep covering it. I'm in a bit of limbo because my doctor just moved away and left the clinic, so I'll be starting with a new doctor. Since my doctor wrote in my records that Entyvio is not working, I wonder if insurance will still approve it. Otherwise, yes, I shouldn't abandon one of my last options too soon.

She suggested Stelara might be the thing to try next, but hard to get approved by insurance. I did try MTX when I was on Remicade, and it didn't do anything except make my liver counts shoot up, so that was considered a failure too.

She has now prescribed Entocort, because she thought it was time for surgery (resection and ileostomy), and maybe that would temper the inflammation before the surgery. But the surgeon disagreed and said I shouldn't have surgery now because I don't have any symptoms! (They were just basing it on my MRI and fistulas). I was very relieved, but now not sure if I should go on the Entocort. I'll try anything at this point, but I also don't want to take so many drugs if it's pointless.

I've been a bit distraught over the ileostomy idea, though I know a lot of people deal with it, so I'd get used to it. But now I'm wondering if that's the only way to get my fistulas to heal, so maybe it wouldn't be the worst thing...sigh.
 
Aloe where in Cali are you?
Try the entocort for sure. Try every treatment you can including diet, probiotics, bone broth. Maybe look into anti map therapy

If you have have a stricture, you may not be able to avoid surgery. Depending on where it is maybe they can do a resection and you can avoid the ostomy. I had a stricture and non draining fistula abscess in my left colon which they cut out and rejoined. It was very successful and no bag. Surgery is not a cure for Crohn's so my feeling is avoid it as long as possible.
And when a SURGEON says not to have surgery that is something I would respect a great deal. Most surgeons only know one thing, let's operate!
 
Natalia Maria said:
Hi David,

I just responded about my experience with the SSI treatment in another thread, but just to get the message out there as much as possible, I'll add my two cents in here as well!

SSI is a vaccine that you administer yourself, every other day; the method is similar to insulin injections commonly used for diabetes for example. Prior to going on the vaccine you are trained by a health professional on how to administer the vaccine properly. The vaccine is composed of dead bacteria - it's all natural and there are no side effects as a result (at least I never experienced any while I was on the vaccine, nor did the patients that I spoke with who were also on it). The vaccine activates the body's immune system by targeting the organs affected by the disease, thereby reversing the chronic inflammation associated with Crohns, Colitis, and other autoimmune diseases. I was on the vaccine for just a little under a year (July 2011 to June 2012). It literally changed my life. I was originally diagnosed with Crohn's in November 2009 and for the first year after the diagnosis I was in excruciating pain, probably because I refused to take all of the crazy drugs that were being pushed my way by my GI specialists. But I was always a firm believer in taking the natural route so I saw a natural path and focused on trying to get better through a better diet, herbs, probiotics, digestive enzymes, the list goes on. And although that did help a little, the pain remained. I ended up in the hospital with a bowel obstruction June 2011 and it was shortly after that, that my natural path told me about the clinical trial for SSI therapy, originally started by Dr. Gunn, a doctor from BC. Since SSI therapy was still in its beginning stages at this point, I actually flew all the way to the Bahamas to participate in the trial since it had not been approved in Canada yet. But now it is, because they have seen so much success with it! I am no longer on the vaccine, and have been symptom free (knock on wood) for almost two years. Following a colonoscopy from March of last year, I was told that I am 100% in remission. I can't stress enough how different my life is now. And that, coming from someone who wasn't even able to get out of bed for days to go to work, is saying a lot. I noticed a difference in my symptoms within 48 hours of taking the vaccine. I would strongly, strongly, recommend this treatment to anyone. Let me know if you have any other questions!
Click to expand...

Hi Natalia Maria,
That is such a great story! Are you still in remission?
 
aloe said:
I posted a ways back that I was thinking about doing this if I was eligible, and wanted to update you on what happened. I talked to the nurse a few times, and explained my situation, and she encouraged me to send in my medical records. I did that, they were reviewed, and they told me it was likely I could qualify. I have stricturing and a fistula, but not really another other symptoms, but still they were saying it might be possible.

My doctor was ready to have me try Entyvio (Remicade, 6mp, and everything else has failed). So I decided to try Entyvio first. Now I'm through 3 months of that, and it has failed too.

I got back in touch with Qu and the person I was working with before has left, and the new person said with my situation I'm definitely not eligible because of the stricturing and fistula, and lack of other symptoms would also be a disadvantage.

So, all that for nothing. A little frustrating they didn't tell me that earlier so I could save some effort, but oh well.
Click to expand...

Hi Aloe,
That is a disappointment. Do you think that this is something - if all goes well, you would want to do once it is approved? Does stricturing affect it working on you or did they mention that it is just because of safety reasons during the trial?
 

Similar threads

my little penguin
FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 In immunocompromised
Replies
1
Views
774
dreamintwilight
dreamintwilight
B
[Now Recruiting] Qu Biologic's Immune Boosting Trial - Phase II
Replies
1
Views
2K
rollinstone
rollinstone
Crohn2357
QBECO-SSI Clinical Trial
Replies
4
Views
3K
David
David
Lady Organic
SSI Qu Biologics trial for Crohn's disease RESULTS
Replies
10
Views
6K
SauceySciencey
S
Lady Organic
SSI Qu Biologics trial for Ulcerative colitis RESULTS
Replies
0
Views
3K
Lady Organic
Lady Organic

Latest posts

Back
Top