Qu Biologics study

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gohabsgo

Joined
Dec 4, 2011
Messages
31
Location
Newwestminster B.C.
Hey everyone. I am new to the group. I wish I could say the same about my crohn's(had for about 30years). I have been ''fortunate'' in that I have had some long stretches of remission without meds(3 years was my best). This past Sept it flared up. I went to tried and trusted pred.(starting at my usual 40m). Always in the past after about 4-5 days my flareup is gone and I do the usual taper. This time MUCH different. It only slowed it down and when I was down to 30m it started to get worse. I was rushed in for an endoscopy. Not a good scene.(believe it or not this was a ''blessing'' in disguise). I had looked into participating in the Qu Biologic study. Turns out the severity of my flare up allowed me to be accepted. I had to jump through allot more hoops(felt like a freakin lab rat),but I am now injecting myself with the treatment. I have given myself 8 injections so far(.10 ml of E.coli every two days in abdomin). I went from a high of 32 washroom ''visits'' down to just 8-10. I am hoping this treatment works. I am also hoping that I can give all of us here a light at the end of the tunnel. The study is for 55 weeks.I will keep everyone posted with my progress.

Tom
 
Igpcarter I don't know if you would be accepted because you have had surgery. You also cannot have been on a biologic for 60 days prior too study.
The only med you can be on is pred, (max 20 mgs). You have to be on a sustained dose for 1 month.

I will keep everyone posted on my hopeful progress. I go in for my first examination on the 27th of Nov. Don't know if I am going to be scoped or not.
 
For sure I will keep everyone posted\

This is also supposed to be a treatment for MAP. I wouldn't be surprised if I have it because I spent my summers when I was a kid from the age of 7-17 on my Grand parents ranch. We drank and consumed RAW dairy.for about 2&1/2 months every summer. I don't know if there is any type of testing for MAP yet. I could find nothing here in Canada. I will ask my gastro. when I seem him in 2 weeks.
 
After 2 months of the injections here are my numbers
hemaglobin-133 was 130
platelet count-416 was 436
lymphocytes-.08 was .07
Reticulocytes immature/total 22.8 was 18.9
Fecal cal protein-3410 was 6860
CRP-6.1 was 11.0
Neutrophils-7.9 was 10.0

My Gastro is quite happy(for the most part) with the results so far. I am for sure feeling quite allot better. My overall bowel movements have gone for a high of 32 times in 24 hours down to approxx. 5-8 times. My overall pain is gone and my abdominal rigidity is gone. I am hoping my latest blood and stool samples(just given today) will show even more improvement. I will keep everyone posted.
 
here are my latest results taken Dec-27
Hemaglobin- 131
Platelet-409
Neutrophils-8.3
Reticulocytes immature/total13.9
CRP-2.1
Fecal calProtectin-1520
Lymphocytes -.09
Total bowel movements 4-5 times a day. Blood 95% gone.

I go for my scope sometime in Feb. I hope by that time it's completely gone.
 
For anyone who may be interested in more information about this trial I just made a post about it with instructions on how to participate.


@lgpcarter
There's a questionnaire available on their trial website that would very quickly let you know if you are eligible.
 
Here are my results from my Feb 22 scope
Everything is normal except my Calprotectin-762(down from a high of 6860)
Blood all gone and bowel movements completely normal (1-2 times per day and stool is normal). All cramping has quit.
My next scope is in early July and my next samples to be given are at the end of April. I am hoping by this time my Calprotectin levels are within normal range.

I now have to taper off Pred. I was on 10mgs when the latest tests and my scope were done. Next tests will be done without any Pred.
 
gohabsgo said:
Here are my results from my Feb 22 scope
Everything is normal except my Calprotectin-762(down from a high of 6860)
Blood all gone and bowel movements completely normal (1-2 times per day and stool is normal). All cramping has quit.
My next scope is in early July and my next samples to be given are at the end of April. I am hoping by this time my Calprotectin levels are within normal range.

I now have to taper off Pred. I was on 10mgs when the latest tests and my scope were done. Next tests will be done without any Pred.
Click to expand...
THat;s so great to hear - congratulations!

Hopefully it won't be too long until we can all benefit from this treatment
 
Gohabsgo - can you tell us any more about how the trial is going?

Am I right in thinking you are part of the initial 20 patient open label trial which will then be followed by the 150 patient double blind placebo controlled study?

Any idea when the results are expected? I was guessing/hoping maybe by summer 2020.
 
My latest results: All blood work normal (except my crp levels are starting to slowly climb. still good at 1.8 but have jumped from 0.7) and my cal protectin level is at 180. No stool sample test required for my Sept blood work which I found kinda strange. Still feeling great but I did have a little bit of a flare up in Aug. Bowel movements were up to about 4-5 day all within about 3-4 hours of waking up. That's all subsided and i am back to normal. However I am now starting to show signs of psoriatic arthritis (may explain climbing crp levels). I have had psoriasis probably as long as I have had crohn's. I have had joint pain on and off in my hands and lower back long before I was in this study. My symptoms are: Waking up in the morning I usually experience tightness in some of my knuckles and cold hands and sometimes heat coming off my wrist joints. It generally improves throughout the day. My back pain is some times quite bad when I get up and what relieves it quite quickly is going for a walk,but walking backwards. I do this every day for about 15 min and by the time I get back home about 90% of the pain is gone. I get the best results if I am walking slightly up hill. I have also started to notice then when I am weightlifting when I grip the bar I get some pain in my knuckles and soon as I let go of the bar the pain increases for a very brief time and then subsides.

Jonny84 sorry for the late response but yes you are correct I am one of the initial 20 patients.

I did ask about when the results will be expected and my case worker wasn't sure. What I can tell you(all of you) is that from what I can gather, when the study is done, It is a wait and see. I finish the injections in early Dec. and I have one more scope same month and that's it. I go see my regular gastro. in ealry Jan. and I would expect (depending on how things are going) that it will be a wait and see. I am sure he will want me to go in for periodic blood tests for monitoring.
 
gohabsgo said:
All blood work normal (except my crp levels are starting to slowly climb. still good at 1.8 but have jumped from 0.7
Click to expand...

Unless you have several more data points confirming the trend, I wouldn't necessarily regard that as a "climb" in you CRP. Both 0.7 and 1.8 are well down in the negative zone. The CRP level just could be bouncing around in the negative zone with no real trend or true climb apparent.
 
Scipio said:
Unless you have several more data points confirming the trend, I wouldn't necessarily regard that as a "climb" in you CRP. Both 0.7 and 1.8 are well down in the negative zone. The CRP level just could be bouncing around in the negative zone with no real trend or true climb apparent.
Click to expand...

I agree with this.
 
My one year Qu biologic study participation (I was in the control group so I was getting the actual treatment, not the placebo) is over. Here are my results. My CRP levels which went from 0.7 in May to 1.8 in Sept to 3.9 in Oct are now(Tested Dec 4th) 0.9. My Calprotectin levels jumped from 180 in May to 1780 in Oct.(Gastro was unsure why and I was surprised that no test was ordered in Dec.) Was not tested in Dec. My actual disease is gone in one spot (it was rated at a est. high 7 out of ten) and the two other spots that are still active, one spot went down form a est. mid 6 to a 3 and the other spot went from a 4 to a three. I feel GREAT and am passing no blood. My bowel movements are between 1-3 times per day and everything is normal. Now I just go live my life and hope for the best. I see my regular Gastro in early Jan. and will see what he thinks about the large spike in my Calprotectin levels. All other blood work was in the normal range.

Jonny84 my case worker told me that they just had the last two patients required enter the study this Dec. It will take at least another year to get the results. I also had some blood taken that was sent for genetic testing. I asked about those results and was told that if they are released to Qu Biologics then I will be informed of the results. I sure hope the results are released.

gohabsgo.
 
In normal clinical trial terminology the "control group" is the group that does not receive the experimental treatment. The control group continues to get the standard of care treatment and/or the placebo.
 
Scipio my case handler told me that when I entered the study I was one of the last to receive the actual treatment. He said that a certain amount of the participants have to receive the actual treatment. I was one of them . He assured me of that. He also referred to me as being in the control group.
 
gohabsgo said:
Scipio my case handler told me that when I entered the study I was one of the last to receive the actual treatment. He said that a certain amount of the participants have to receive the actual treatment. I was one of them . He assured me of that. He also referred to me as being in the control group.
Click to expand...

Hmm...well in that case for some reason your handler was using the "control group" term the opposite of the way it is normally used.

https://en.wikipedia.org/wiki/Clinical_control_group
 
I was under the impression that people in the clinical studies (both in the control group and not) are not aware if they receive placebo or an actual treatment. The idea is to take into account and measure the placebo effect which can be quite substantial. Sometimes you see over 20% of participants indicating improvement without actually receiving any treatment.
 
paulk said:
I was under the impression that people in the clinical studies (both in the control group and not) are not aware if they receive placebo or an actual treatment. The idea is to take into account and measure the placebo effect which can be quite substantial. Sometimes you see over 20% of participants indicating improvement without actually receiving any treatment.
Click to expand...


Some are and some aren't. Some trials are "blinded," meaning that neither the doctor nor the patient knows whether any given patient is in the control group or the experimental group. Other trials are "open label," meaning that the doctor and probably also the patient know who is getting what.

A blinded study is considered to be a scientifically stronger trial, since it minimizes the chances of a significant placebo effect.
 
I think you are both right, as I understand it control group got placebo initially then drug, experimental group got drug straight away.

Thanks for the update on your experience, this is the most promising thing I've read about in a while so it is great to hear any news.
 
I was in the open label group. Phase two(the double blind part) is just about to test the last two patients.
Qu Bio has realized that when you are injecting the treatment you get a local reaction(which I was getting). The placebo gives no such thing. They have apparently put an additive in the placebo to mimic the same reaction.
 
Delta_hippo said:
I think you are both right, as I understand it control group got placebo initially then drug, experimental group got drug straight away.
Click to expand...

A clinical trial design where some subjects first get placebo and then get switched to the experimental treatment later (and/or the other way around) is called a "cross-over study."
 

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