SSI Vaccine Trial

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You do understand that you DO get the real SSI at a certain point even if you get the placebo initially, correct?

If I was in your place:

1. If the stricture was due to inflammation, I would try SSI before I let them do surgery and I would be willing to go off Remicade to do that. If you have active inflammation with Remicade, in my opinion it is not working well enough and it is worth trying something else.

2. If the stricture was due to scarring and I had active inflammation elsewhere, I would do SSI before the surgery in an attempt to reach remission as that often leads to better surgical outcomes. I would be willing to go off Remicade due to that.

3. If the stricture was due to scarring from old inflammation but I was in remission from the Remicade otherwise, I might just stick with the Remicade.

That's just me though. We each have to weigh our own countless variables and hopefully we have doctors that can help us do that.
 
David said:
You do understand that you DO get the real SSI at a certain point even if you get the placebo initially, correct?
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Yes, I understand. Just a little flustered after the colonoscopy today.
If I was in your place:

1. If the stricture was due to inflammation, I would try SSI before I let them do surgery and I would be willing to go off Remicade to do that. If you have active inflammation with Remicade, in my opinion it is not working well enough and it is worth trying something else.

2. If the stricture was due to scarring and I had active inflammation elsewhere, I would do SSI before the surgery in an attempt to reach remission as that often leads to better surgical outcomes. I would be willing to go off Remicade due to that.

3. If the stricture was due to scarring from old inflammation but I was in remission from the Remicade otherwise, I might just stick with the Remicade.

That's just me though. We each have to weigh our own countless variables and hopefully we have doctors that can help us do that.
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Thanks David. Your words are heeded.

I do have active inflammation, my current CRP is around 4.7 and my ESR around 48. I don't believe I am in remission even while on the Remi. To be honest I have no idea what remission even feels like, my BM's have been unformed for so long. I guess my appointment with the surgeon in the near future and my biopsy results will determine whether the stricture is from active inflammation or old inflammation that scarred.

Qu has received my medical records and Doctor Bressler is looking through them to see if I will be a good patient for the study. I should be informed shortly on whether they want to proceed with me as a patient.
 
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Ok, so I am heading over to Vancouver for a second visit. This time I will get the real deal, so typical that I got the "sugar water" it has made me crohns worse, being out any medication for this time. Anyhow, let´s see how this will get.
 
Things are still good/improving here sir.clausin - I am hoping the unpleasantness of the placebo will be as worth it for you as it has been for me!
 
Just woke up, last day was my first day of the open label, and I think I am on the actual stuff, not the placebo! ;) Happy times
 
Just got home from an epic weekend of wedding photography ! It's been almost a year since I shot a wedding and I haven't gone and done any events since November. It was a huge milestone for me mentally and I am super pleased to report that today may be my best day in living memory.

So happy to hear you're on the right track Sir.Clausin !!!
 
Man, so happy to hear that! Can't wait for this trial to be spread around the globe, I think they're on to a winner! How are the rest of you going? Wends, bees etc
 
anti_map said:
When will this vaccine be available?
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This treatment won't be available for those outside of the clinical trial for at least a couple years. They have to finish this trial, do a phase III trial, then get final approval if the data supports getting approved which hopefully it will.
 
I can't wait until it's available. I tried to to get into the trial but I was rejected because my stricture was too bad. It was sooooo disappointing. Now I'm on humira but it doesn't seem to be doing much.
 
Hi all,

Thought I would share my story. I was diagnosed with CD in 2012 during my last year of medical residency. I had learned about IBD during med school and thought it was mainly just some abd pain and loose stools. Boy was I wrong. I've suffered so much with flu like symptoms and severe fatigue. I tried controlling it with prednisone but the side effects were just about as bad as the disease at times. I refused biologics or immunosuppressants. This lead me to the SSI vaccine trial. I was in the placebo group for the first phase and have now been on the real thing for about 6 weeks. I've noticed some improvement in my symptoms especially the pain and energy reserve. I used to have a constant knot in my right lower quadrant of my abd that is mostly gone. My stools have definitely become denser and more formed. I still wouldn't qualify them as normal but improved. I still have some burning with defecation occasionally. I have gained almost a pound each of the past 6 weeks.

I'm grateful I stumbled on crohns forum. Look forward to hearing others stories and updates on their progress as well. Thanks to all of you who are also participating. I think this will be revolutionary and certainly better than the current "treatments" being offered.
 
Thanks for taking the time to share your story cicconeca! Out of curiosity, why did you decide to refuse immunosuppressants and biologics? I hope your symptoms continue to improve and you are able to reach deep, stable remission!
 
Hi David,

Thanks for your reply.

To be honest, some of it was timing. I started looking for alternatives to the standard treatments. I held out and got enrolled in the study.

My main concern with Imuran/6-MP was the nearly fourfold increased risk of lymphoma, at least in preliminary studies.

I refused biologics with the concern of drug-induced lupus and worried about decreased efficacy over time.

If SSI had not been available in all reality I may have had no choice but to start other traditional meds.

The med school I attended always encouraged us to question the status quo and to look for more natural therapies with less side effects and lower risk profile. To me SSI therapy is better in so many ways. It's definitely not an over night cure, but my feeling is you don't develop CD overnight either so it will take time. And for the first time this therapy offers hope of cure instead of just shutting down the adaptive immune system and masking symptoms.

Hope I answered your questions.
 
Hi All :) cicconeca, glad that you found the trial and that you found us :) Welcome! I have a very similar story to you.
Anyway, here is my update: I just got back from my week 16 visit in vancouver. I am doing pretty well. I am not in remission but i am better than I have been. I still have up and downs but my downs have not been so bad and my ups feel like remission sometimes, which is such a wonderful feeling. I really wish that I had been able to achieve sustained remission with this study quickly, but it is possible that the positive affect will continue to build and i could still get there. time will tell. for those of you who want all the details, my bm's are usually pretty formed, 1-2 per day with moderate urgency and mild pain, no blood, my fissure is still healing (the formed stool doesn't help that) i still have stomach pain sometimes and bloating with gas but those have improved slightly. i still feel fatigued and just generally yucky some days but not everyday anymore. still no joint pain.
last time i wrote i was battling a major head cold, that went away finally and now i am battling a lovely uti. i hate antibiotics but took them after a few days of terrible pain and they didn't even work! ugh hopefully that will resolve soon and its not something related to the crohns or make it worse!
 
So as of now, I am not going to be participating in the trial. There's too much of a chance that I get the placebo and get extremely sick while off remicade.

Remicade is not fixing me, as evidenced by my latest colonoscopy, but it's keeping things from becoming unbearable, therefore I can't really take the chance. Sucks this thing is so far away from being approved for market use.

Oh well for now.

edit - plus side is I got a fecal cal test done for the first time ever and my level was 1240. Not so good lol. CRP is 15.
 
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How's everyone else travelling? Been a bit quiet which hopefully is a good sign that you're doing better and getting on w life? :)
 
Wendsjoy,

That's awesome that you saw some significant improvement! I wish you were able to stay on the treatment longer. I hope things continue to improve going forward for you. Sucks about the UTI though :(
 
Poppysocks, with a fecal calprotectin that high, your doctor needs to change SOMETHING up. I don't know if duration between your Remicade dosages can be shortened as I don't know your time between dosages, but keeping your treatment regimen as is would be a big mistake in my opinion.
 
I'm curious about those who were previously in the compassionate use program, especially as to the timing of their recovery. Did it take weeks or months and at what point was stable remission achieved. I've heard Dr. Sutcliffe say it's possible it may take at least 4 months of therapy for a lasting clinical response. I know Tyler, Natalia and Colleen have participated in this thread before. Is there any chance you guys could go more in detail about your recovery timeline?
 
David said:
Poppysocks, with a fecal calprotectin that high, your doctor needs to change SOMETHING up. I don't know if duration between your Remicade dosages can be shortened as I don't know your time between dosages, but keeping your treatment regimen as is would be a big mistake in my opinion.
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I know it's high. Believe me, I'm looking for all other possibilities right now.

I have been thinking of adding Methotrexate to the mix, and going back to monthly remicade infusions. I also have an appointment with an immunologist next week to talk about ivig. Believe me, I'm not just sitting around. GI docs around Naples are all horrid.

In addition to all that, this whole year I've been experimenting with diet, trying to spread out my remicade's as much as possible to see if it was helping. I've at least found out I'm very sensitive to dairy. I broke out in Shingles at the end of last year probably due to the Remi, and I've been trying to spread them out as much as possible. Prior to the Shingles the Remi wasn't keeping my inflammation markers down either, and I hadn't had a formed bowel movement in as long as I could remember. I added Mesalamine enemas to the mix and they've improved the formation of my BM's greatly. Hasn't fixed the sticture or inflammation though obviously.

Doc said he was going to set me up with a colorectoral surgeon but haven't heard from him. Not that it matters, I know what the surgeon is going to recommend, and I'm not doing it. Don't care.

Weird thing is, is I actually feel pretty good. Nothing is hurting as long as I stay away from certain foods (dairy). Doesn't hurt when I go to the bathroom. If I push out my Remi's past 7-8 weeks it starts to get painful and I really have to force myself to eat. My appetite has been very lacking the past few days, which is probably a sign of the inflammation. Other than that though I feel good. Of course I say this, I haven't been "truly" healthy in so long I don't even know what it feels like.

Sorry to hijack SSi Thread. Carry on. Wish they could put ssi on fast track status or something.
 
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Still here too :)

Feeling pretty great still, same old ups and downs but still trending up. Been a stressful month or so with work but I survived and almost have caught up enough to focus a little more on recovery.

I'm really just holding my breath. Things right now are really good and if they keep getting better that's pretty amazing. Just can't help thinking it's too good to be true.

I know, I know, think positive. If only it were that easy, haha.

Still iffy joints. Fingers and toes mostly, wrists and ankles occasionally. Does seem very weather dependent but is mild and 100x improved from the last couple of years.

Odd stomach pains still, cramps, gurgling (less noise and less often but still there) and the occasional bit of gas or heartburn but other than the pain/cramping I probably rate lower than your average 20-something North American on that scale.

My weight has been up and down like crazy since this time last year without a real rhyme or reason at times but it's starting to seem like it's normalizing as well and I am gaining or loosing weight in relation to thing like food and exercise again.
 
Nope! But they did offer and I've been meaning to get it figured out shortly. I have to go in soon to renew my Mezavant so I'll see if I can get some info.

Fecal Cal and CRP - anything else of specific interest? Should have quite a lot of info banked from the last 9 months.
 
Still feeling great!

I barely notice any symptoms these days when I stick to the diet that over the years I've learned helps me (reduced intake of dairy, red meat, sugar, and fat, increase in probiotic rich foods like kimchi). Did a 5 hour road trip this weekend and my knees got pretty sore from staying in the same position for too long.

I'm now done the study and my last labs. I have agreed to participate in the follow up study for this treatment (apparently I'm the first), which involves periodic phone interviews.

I live 5 minutes from the Qu folks, I'll have to pop over some time and get copies of my test results for you guys.
 
bees said:
Still feeling great!

I barely notice any symptoms these days when I stick to the diet that over the years I've learned helps me (reduced intake of dairy, red meat, sugar, and fat, increase in probiotic rich foods like kimchi). Did a 5 hour road trip this weekend and my knees got pretty sore from staying in the same position for too long.

I'm now done the study and my last labs. I have agreed to participate in the follow up study for this treatment (apparently I'm the first), which involves periodic phone interviews.

I live 5 minutes from the Qu folks, I'll have to pop over some time and get copies of my test results for you guys.
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Bees, what was your fecal cal and crp before and after taking the treatment?
 
Any updates? Everyone has been really quiet which I hope is a good thing, trev, wendsjoy, very interested to see oh you guys are going, likewise sir clausin, how are you going?
 
My specimens when out Tuesday from Quest. Abby said it should take about a week for results, then I'll know if I'm going. Did anybody get their lab results that fast or did it take longer?
 
Hey everyone, sorry for the absence. I got a new job and have been super busy with the family lately.
I am not doing all that great. I am not sure that I was on the SSI long enough. It really worked for me. I didn't realize how good i was actually feeling until I went off of it and have been without it for a while now. I wish they could get it approved fast so that I can get it again and stay on it longer this time! Good luck to all of you who are getting involved. It has a lot of promise for us Crohnies :)
 
That sucks you're not doing so well, hope you feel better soon, what are your plans for getting over the recent hump or to tied you ever until ssi is readily available? Hopefully it gets fast tracked once the trials show efficacy.
 
Not sure yet what the plans are...I have an appointment with my GI next week. Not sure what I want to do yet, been researching a lot and trying to decide which road I want to go down. Just praying for fast approval somehow!
I am still so thankful that I was able to participate in this study, even if it was a short lived relief. It really did help me. I made a little graph of my lab work. It is pretty cool to see it on paper. It certianly proved that the SSI did help me. A lot!
 
Well I think if you saw benefit from it, the chances that your problems are caused by some sort of mycobacterium or other infection are pretty good, so you might be one of the people that responds really well to anti-map antibiotics (they penetrate macrophages, the ssi vaccine looks at getting your body to make new macrophages and get rid of the old ones where the theory is that's what's malfunctioning bla bla I'm not scientist but it makes sense to me) either way I hope you find your golden bullet soon, maybe the ssi is it and you just need to be on it longer so your body can completely reboot the immune system, plz keep us posted either way. Bless
 
Wendsjoy said:
Hey everyone, sorry for the absence. I got a new job and have been super busy with the family lately.
I am not doing all that great. I am not sure that I was on the SSI long enough. It really worked for me. I didn't realize how good i was actually feeling until I went off of it and have been without it for a while now. I wish they could get it approved fast so that I can get it again and stay on it longer this time! Good luck to all of you who are getting involved. It has a lot of promise for us Crohnies :)
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:(

I'm so sorry to hear you've fallen back on hard times. That makes me sad. While I absolutely understand the need for proper testing and regulation of medications, it's times like this I wish Qu Biologics would just register SSI as a pesticide so that they could inject a few rats, make sure they don't die, then unleash it on humans for them to use as they please.

I hope your GI has some good treatment options for you.
 
Its so promising these new vaccines being developed. I just wish they could be on some type of fast track status. People with crohns are suffering so badly and this would be such a great medication with minimal side effects and deeper remissions.

They still have to do a 3rd trial. This could take another 3 yrs to get approved
 
I actually think 3 years is generous. I think it'll be more like 5 in the US. Maybe sooner in Canada. Time will tell. It's still a great thing. Especially for the next generation of Chronies. The numbers are only growing. I have an 11 year old cousin just diagnosed and suffering tremendously. Hopefully it'll be soon enough to save him from surgery. Or to save my own children if they end up with this because of their genetic makeup.
 
Poppysocks said:
Its so promising these new vaccines being developed. I just wish they could be on some type of fast track status. People with crohns are suffering so badly and this would be such a great medication with minimal side effects and deeper remissions.

They still have to do a 3rd trial. This could take another 3 yrs to get approved
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There's no way it'll be done in 3 years. The current trial is only a phase 1/2a trial. Once this is done (and they're still recruiting patients), a phase 2b trial will have to start. After that a 3a, and then 3b trial will have to be done. We're looking at about another 8 years..maybe 5 if it's fast-tracked.
 
I haven't posted in a while. For those who do not remember or didn't read back to my first post. I was one of the first people to have the complete SSI treatment experience and remission.

I am so happy to see that this is making people feel better. Everyone with Crohns has different pains and experiences with the drugs that are available. We need to get at least another 60 people attempting to enroll in the trial in order to move this through. As posted previously, it could take 3+ years to get this to market. If we can be brave and encourage others to be brave, this amazing treatment could move through the system a lot faster. Which would mean it would be more readily available and generations to come would never have to live through this experience.

Keep spreading the word and getting healthy! And a HUGE thanks to everyone trying this!
 
A few comments.

1) I have spoken to some folks high up in QU biologics and Univ of BC. They really may be onto something- SSI is really something to pay attention to down the road.

2) "down the road" though cannot be overemphasized enough. Keep in mind the current tiral is really all about safety. Yes, CDAI/HBI scores are being looked at, but scopes, biopsies are not being done. This is YEARS away from being available. Keep in mind each trial can take years to conduct, review, write up, get peer reviewed, published, confirmed. I think 3-5 years is a pipe dream- 8, maybe if everything goes on time. Possbily longer. Now, if there are some staggering incredible results or another compassionate use occurs with great results, some fastracking is possible, but beyond that this is years, MANY years from being away.

3) The QBECO SSI vaccine contains an inactivated E. coli bug. E. Coli is NOT at all anywhere near the same type of organism as MAP. Sure, it would confirm bacteria/infection is involved with crohns, but we basically know that already.

4) What is hurting QU biologics right now is location. It is not easy for patients to get out to Vancouver for 10 day stretches, even with costs taken care of. Not many people can drop family/jobs for these stretches and commit to going all the way out there. I wish they would join forces with a US Northeast university or company and have open an arm here. I honestly think if there were an arm here in NY of Philly this would take off and get a lot more publicity, and maybe speed the studies up a little.

In a nutshell, this is very promising research. They have theory, data, and scholarly approach. But the wheels turn VERY VERY slowly. Not something any of us want to hear, but it is the reality.
 
Spoke with rep from Qu Biologics today, in process of getting medical records for the SSI Trial. If I am approved and all goes according to plan she said I would likely come for first visit and first injection near the end of November. How long did it take those accepted to go from step one to first injection?

This trial is something I'm willing to attempt before moving onto Azathioprine as my IBD doctor would prefer. Currently on 20mg Prednisone as dropping to anything lower causes me to flare right now.
 
whyclef said:
Spoke with rep from Qu Biologics today, in process of getting medical records for the SSI Trial. If I am approved and all goes according to plan she said I would likely come for first visit and first injection near the end of November. How long did it take those accepted to go from step one to first injection?

This trial is something I'm willing to attempt before moving onto Azathioprine as my IBD doctor would prefer. Currently on 20mg Prednisone as dropping to anything lower causes me to flare right now.
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Definitely try get in the trial over aza, could fix you up for good.

As for ssi taking years, what about compassionate use? For instance inAustralia if people are all out of options they are allowed to use medication still under trial through compassionate use, surely SSI would be the same, albeit in Canada...
 
whyclef said:
Spoke with rep from Qu Biologics today, in process of getting medical records for the SSI Trial. If I am approved and all goes according to plan she said I would likely come for first visit and first injection near the end of November. How long did it take those accepted to go from step one to first injection?
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If you have your passport and medical documentation of Crohn's diagnosis that is at least six months old, you can print out the pages to sign with the study nurse then she will send out your specimen kit right away.
 
PatientlyMary said:
If you have your passport and medical documentation of Crohn's diagnosis that is at least six months old, you can print out the pages to sign with the study nurse then she will send out your specimen kit right away.
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I heard from Abby (Qu Trial Admin Assistant) on Friday saying that she was mailing my specimen kit, so I should receive it some time this next week. All of the people at Qu have been great to work with through the process.

Also, impressed with my IBD physician as he took time to research the Qu trial and personally call Dr. Bressler plus one other lead IBD researcher in the USA to ask questions. He called me to explain all he had learned and said he felt like it was good for me to give this trial a Go over Azathioprine. I think what really peaked his curiosity was when I shared the results that some of my fellow Crohnies experienced from the SSI Vaccine Trial.
 
I think its too bad QuBiogics demands CRP level as a main mesuring criteria. This discriminate a lot of potential patients who mostly only have endoscopic findings as proof of disease activity and possibly a different disease phenotypes. many of us do not show increase CRP level until reaching an extreme point of disease activity. I am in a moderate recto-colitis flare right now and my CRP is not showing, only my plaquets are a bit elevated, so I cant partcipate in this study unfortunately.

I tried to enroll in a FMT trial in Alberta too, got my GI approuval, but the researcher only wants Alberta people, yet she wants mild to moderate and now my colitis has escalated into a more severe category unfortunately so i coundnt participate anyway. after coloscopy my GI prescribed 40mg pred, but I feel I'll have to increase it to 50 tomorrow because my symptoms are not improuving much to my expectations since 3 days, as they did very rapdly, within days, almost back to normal, in the past. Lots of unknown coming ahead for me...
 
I agree that I wish they had a local trial here in the states. It's so great this is being done but the location is a big issue.
 
Lady Organic said:
I think its too bad QuBiogics demands CRP level as a main mesuring criteria. This discriminate a lot of potential patients who mostly only have endoscopic findings as proof of disease activity and possibly a different disease phenotypes. many of us do not show increase CRP level until reaching an extreme point of disease activity. I am in a moderate recto-colitis flare right now and my CRP is not showing, only my plaquets are a bit elevated, so I cant partcipate in this study unfortunately.
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I think you should still try to get in, CRP is not the only way to show active disease for the Qu trial. If you haven't already called them, it wouldn't hurt to ask more about it.

I don't know as much about testing and labs, but the Qu e-mail said something about endoscopy results? See below:


......A copy of the endoscopy OR radiology report(s) used to confirm your diagnosis of Crohn’s Disease
......A copy of the histopathology report(s) used to confirm your diagnosis of Crohn’s Disease
.......A copy of any lab investigations, endoscopy, radiology and relevant medical history from within the last 3 months
 
rollinstone said:
My crp is never really elevated either
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I just want to add that my CPR is never elevated either, and I stoned poor Abby about this from the start, because I was sure that I would never be accepted into the trail. But, she said that they have different (lower, I guess?) numbers that they are looking for. Sure enough, my serum results came back positive for the trial.

And you can always do the screening package again if you are not positive the first time.
 
David said:
Sounds like one heck of a doctor you have there whyclef. What was his take on everything?
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My IBD doctor said that he was hoping for more study on how the treatment actually works, such as lab rat studies and research papers to show the mechanism of action. However, he said that he felt confident the trial was safe based on his conversations with Dr. Bressler and based on the self-reported results I shared with him from this forum. Considering the chance it could put me into remission for a year or longer, he felt it was certainly worth putting the immunomodulators on hold and trying to get approved for the Qu Trial. I would be his first patient in this trial, so I perceived he is also intrigued to see how I do since it could be helpful to other IBD patients at his practice.
 
thanks Mary,

I had called in the summer when I was wrongly diagnosed by my GP with an perianal abscess (turned out to be hemmorhoid). My GI was on vacation, so I took antibiotics while waiting for his return... I am thinking maybe those antibiotics could have even possibly played a role in my current flare.

I spoke with the rep who mentionned a specific number for CRP which i knew I would only get if my disease would be really extreme. But I 'll definately give them a call again tomorrow, mentionning my new story. thx.
 
Keep in mind this is an early study that is not involving pre and post study scopes/biopsiees, but still requires some objective criteria as an outcome measure. Since there is a placebo control there has to be some level of objective control on results as well. Simply doing a CDAI or HBI score can skew results simply because of placebo effect. Also, please remember that the poster presented at DDW this past May in Chicago was about folks with "moderate to severe" disease. The fact remains that most people with moderate to severe disease chronically will often develop some abnormalities in labs. True, not everyone will, but the CRP is NOT the only marker they are using.

My bigger complaint is about location. Though there may be financial (and other) reasons behind it, I wish they would partner and open another arm to this study. I do not have the time or desire to leave my family and job for 10 days at a time to go more than 3K miles, and I imagine many other don't either, even if it is all expenses paid.
 
I just got off the phone with Abby at Qu and it looks like I'll be there November 10-14. And I can fly home Friday afternoon!

I will only be in Vancouver for FIVE days!!!

If you are travelling a long distance to Vancouver, they only require five days (M-F) now for week one & week eight of the trial.

I hope more people will be able to try to get in this Qu trial now. Every little bit helps.
 
Paging some of the people in the trial, Trevor, bees etc, how are you guys going? Been awful quiet from you all, hope that's a good sign.
 
I talked to Abby yesterday.I told her a big concern for me is if it does not work for me,can I go back to Remicade? The timing is good because I just had my infusion and my next is not for another eight weeks.Abby said you have to be off biologics for at least two months to be considered,so I can talk with my GI before the next infusion.

I have a good rapport with his nurse.I'll call her and see if she can get my GI to check out the QU website.I would like to go into my appointment with him already knowing what I would like to do.Instead of the appointment being the first time he hears of it.

I have talked to my colorectal surgeon and he feels I should not do it.He would be for it if it wasn't double blind.I know his concern is genuine.What damage would CD do to me if I got a placebo and it didn't work? If I was told I could go back to Remicade(it is helping me)if the trial didn't work I would call Abby right back and say sign me up.

What if it did work? I'll call my GI's office.
 
rollinstone said:
Paging some of the people in the trial, Trevor, bees etc, how are you guys going? Been awful quiet from you all, hope that's a good sign.
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Oh boy. Not good news...

Crashed and burned about 8 weeks after the end of the trial. Actually pretty spectacularly. No more job, back on Pred and just waiting for the Humira :(

Sorry, guys.

If you're reading this and about to start or considering starting the SSI, it did some good stuff for me. It sucks it couldn't keep me where I was once I stopped taking it but this is where I was before so it's not that it made me worse.

I'll try and be around more. Been a rough go the last few weeks.
 
David said:
Damn, that makes me so sad Trevor. I'm so sorry :(

*hugs*

You flared which caused you to lose your job? Or the other way around?
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Hard to say, haha. If I were healthy I'd for sure have the job still but there were quite a few factors. My manager left just as I was getting bad again and the extra stress for sure did not help. My whole life kinda blew up so the job seems less important right now. Thank god for family and friends.

The Pred + pot is not a great mix (for me) so I'm just on Pred (tapered quickly from 50 to 35 after it kicked in and seem to be doing well enough) and the Humira should be showing up any day now!
 
That's awful Trevor (and Wendsjoy). It was good to hear good news for once (while it lasted). I'm actually starting the trial Dec 15, once my labs come back again. The time ran out on my first try. I'm going to ask them if they will keep some of us on the drug longer if it's necessary for remission, like in the compassionate use trial?
 
Trevor said:
Oh boy. Not good news...

Crashed and burned about 8 weeks after the end of the trial. Actually pretty spectacularly. No more job, back on Pred and just waiting for the Humira :(
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Trevor, sorry to hear you became unwell soon after stopping treatment. Hope that you can get your symptoms back under control soon.

Thank you for participating in the trial and keeping us updated.
 
Trevor!! Good to hear from you! We are in the same boat once again. :( hope things look up for you really soon!!
 
rollinstone said:
Anyone have any idea of how long the compassionate use program was for as opposed to this 8 week trial?
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From the Qu site, perhaps at least 3 months.

http://www.qubiologics.com/studies/compassionate-human-use-program/

Ten of ten patients had a therapeutic response to treatment, based on patient-reported improvement in symptoms. The majority of patients achieved therapeutic response within one to three weeks of starting treatment. Seven of the ten patients (70%) with Crohn’s disease had full resolution of clinical symptoms after completing a course of QBECO treatment of three months duration or more. Three of these patients have had sustained clinical remission after discontinuing all medications including SSI treatment. The longest clinical remission is ongoing, after 4 years. Three of ten patients (30%) have had follow-up colonoscopies or CT scan with confirmation of full remission.
 
I think Tyler Wilson was on it for over a year, not exactly sure tho. That's what phase 2 will probably be. Dose and duration.
 
Oh man, I really hope they can get compassionate grounds to speed up approval.. 8 weeks does seem pretty short, hank all of you so much for partaking in the study
 
Started Humira last night along with olestyr. Fingers crossed.

And yet another journey begins. These things always happen right before Christmas...
 
I'm wondering how much different the results are for those who are 'responders' and are technically on SSI for the whole 16 weeks of the trial vs nonresponders, who are on the drug the last 8 weeks only?
 
Update: added Ativan and some sort of anxiety/depression med - Pred really messed with my nerves/head. Hopefully short term as they get me all the way off the steriods.

Combo of humira, Mezavant and Olyster (sp?) seems to be kicking in. What a mess, lol.

Going to give the trial a call as soon as I get my head straight and see if they have anything to say as far as future opportunities.
 
You'll get there bro, anxiety can be brutal, I was going through it for a little while, I think it's intrinsically linked to intestinal inflamation.. Hopefully ssi will be able to offer compassionate use of the drug, I don't understand why they can't I mean there are some scary drugs that are allowed to be used off label in certain circumstances
 
rollinstone said:
You'll get there bro, anxiety can be brutal, I was going through it for a little while, I think it's intrinsically linked to intestinal inflamation.. Hopefully ssi will be able to offer compassionate use of the drug, I don't understand why they can't I mean there are some scary drugs that are allowed to be used off label in certain circumstances
Click to expand...
What does it mean if a drug is offered as "compassionate use"?
 
Well i think, and I could be wrong but afaik it's when something is given to patients with the drug being approved for that condition, now that being said the drug may be approved for another condition.. For instance there are some people here in Aus using stelara on compassionate use because they failed the other biologics.. I'm sure once this trial is done they'll be able to offer it in some circumstances, let's hope anyway.
 
Accepted to trial and travel booked. I will be there January 5-9, 2015. Will keep everyone posted on how it goes. Right now sitting at 20mg prednisone as you cannot change steroid dosage for 2 weeks prior to trial.
 
I got home from Vancouver a week and a half ago, but my 77 year old mom had a medical emergency in NY the day I was supposed to start the trial, on Dec 15th.

I didn't actually qualify for the trial. My pre-trial diary didn't show my normal disease activity for various reasons, stress over flying conditions and family stuff. I told Shelly that the diary wasn't representational of my normal life so we agreed to resubmit when I didn't have worries about weather, etc. By the time I got back to the hotel on Monday afternoon, I had messages saying mom's had stroke, which we later discovered was actually a brain tumor. At that point that I was so grateful not to be in the trial. I would not be able to return in eight weeks if her prognosis is bad. We have been waiting for her biopsy results.
 
SSI Vaccine Q&A with Dr. Gunn

Dr. Gunn from Qu Biologics recently did a Reddit Q&A session (AMA). Here's the thread with Dr. Gunn's answers.

My question sought a clarification of whether this is AIEC-specific or not. I'm very pleased to learn that it tries to fix the innate immune system's macrophage dysfunction, so it can target any pathogenic trigger.

Give it a read. Exciting stuff!
 
Last edited:
I just submitted the pre-screening questionnaire for the study and was wondering if anyone knows what medications (or what medications within a certain time period) make you ineligible. I'm currently on Entyvio and methotrexate, but I'm scheduled to switch to Remicade in a couple of weeks. I don't want to get my hopes up if there are restrictions. Thanks!
 
Any immune modulating meds may DQ you. The SSI is an immuno-modulator so you probably can't be immunosuppressed.
Not sure though. Hopefully it works out for you!
 
Hi! I'm ok. Started humira about a month ago :/ not happy about that but hoping it helps and I can stop taking it when/if the SSI becomes available in the U.S.!
 

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