Golimumab Study Starting

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Dr-A
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Date Joined Jul 2006
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   Posted 12/9/2008 11:50 AM (GMT -6)   
Well, I get to start this study next week. Had choice between this Humira, or remi for my next treatment stage, and this seemed to be the better choice at this point in my life. After getting stuck 6 times last week from the nurse trying to get blood, 12 lead EKG, chest x-rays, poo tests, tb skin test, I think I should be all clear. Only thing left is flex sig next week to start the thing off. Then its 30 min infusion and wait for 6 weeks. Then get stuck in next study which lasts another umpteem months with same drug. I don't have to change any of the meds I am taking, so it will be interesting to see how it works if I get the drug and no placebo. Not a whole lot of info here on it so, I'll try and keep things updated as I go through it. Seems Severin did well for a bit with it.

For me, I am tired of treating inflammation, and would much rather target it before it starts. I am not in a bad flare at this time, so there is not much risk if I happen to get placebo, but a possible great benefit if it actually works.


Detailed Description:

CNTO 148 (golimumab) is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body that may cause long-term inflammation. CNTO 148 (golimumab) may help treat this disease by blocking the activity of TNF in the body and reducing the symptoms of ulcerative colitis(UC).This study will assess the safety and effectiveness of intravenously (through a vein in the arm) administered CNTO 148 (golimumab) and determine if there is a reduction of signs and symptoms (such as diarrhea and rectal bleeding) in patients with active ulcerative colitis. The effect of intravenously (IV) administered CNTO 148 (golimumab) on the quality of life in patients with ulcerative colitis will also be assessed. about 676 patients will take part in the study at approximately 150 centers. Participation in the study will last for six weeks. At week 6, patients will be asked to participate in an additional 54-week maintenance study and a long-term extension study (CR014188) that will last approximately 3 years. If the patient chooses not to participate in the maintenance study, their participation in this study will extend 16 weeks after the last dose of study medication at Week 0.There are two parts to this study. Part 1 is called "dose-ranging" and will enroll 176 patients. Patients enrolled in Part 1, will be equally assigned to a single intravenous (into the vein) infusion of either placebo or 1 mg/kg, 2 mg/kg or 4 mg/kg of CNTO 148 (golimumab). Part 2 of the study is called "dose confirming" and will enroll 500 patients. Patients will be equally assigned to the same doses studied in Part 1 until the doses for Part 2 are selected. At the time that the final doses are selected, all newly enrolled patients will be equally assigned to one of the selected doses or placebo. This entire study is "blinded." This means that neither the patient nor the study doctor will know which treatment the patient has received. The overall purpose of this trial is to determine if treatment with CNTO 148 (golimumab) is better than treatment with placebo in reducing a patient's signs and symptoms of ulcerative colitis.

Patients will receive a single infusion at Week 0 of either placebo or CNTO 148 (golimumab) 1 mg/kg, 2 mg/kg or 4 mg/kg.
Proctitis DX 1999, Pancolitis DX 2008
Lialda 3 day
Immuran
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA

Post Edited (Dr-A) : 12/9/2008 10:57:14 AM (GMT-7)


ediekristen
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Date Joined Apr 2007
Total Posts : 1366
   Posted 12/9/2008 12:37 PM (GMT -6)   
I almost signed up for this study, but the test site was a bit too far for me to drive so frequently and I wasn't sure if my doctor would be on board with it either. I hope you have good luck with it, keep us posted!

Female, 23, Ulcerative colitis (pancolitis) since 1999; GERD; gastritis; osteopenia in femur head & lumbar spine from long term prednisone use...

Current Meds:
Lexapro 10mg, Azasan 100mg

 
 


TaylorB
Regular Member


Date Joined Jun 2007
Total Posts : 76
   Posted 12/10/2008 6:33 AM (GMT -6)   

my husband and i are both signed up for this study.  our flex-sigs are tomorrow.  our drug, golimumab, will be administered sub q. (a shot) not IV infusion.  we are located near columbus ohio.  my husband works in columbus, but we live 1.5 hrs. away and i have to drive in.  i am nervous.  my husband is having a flair after 8 years in remission.  i have never had a remission, but i do not take any drugs for uc at this time.  i took asacol and other mesalamine drugs for 6 years, never got even a little better, was sick every day.  when i went off the drugs, now am sick only 3 days a week (approx.)  which is weird, that i was sicker on the drugs than off.  but i am very sick on the sick days. 

i am interested to see what the flex sig will show tomorrow, i havent had a colonscopy in 1.5 years or so.  also, i see you can stay on your current drugs, my husband can stay on his asacol, but can not take any rectal meds prior to and during the study.

 

 


Dr-A
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Date Joined Jul 2006
Total Posts : 2105
   Posted 12/10/2008 8:26 AM (GMT -6)   
Yeah, there are a few differences. I can't do the rectal stuff either. I even asked if I could use vitamin E enemas, and the lady had to ask the study people, lol. NO. Mine is SQ also, not sure why the web version is IV. I just pulled the study info off the web, since it's pretty close. If you want post your stuff in this thread and we can keep tabs on each other since we have several people in it now, or make another thread. Luckily I only have to drive to my GI doc in Nashville for this about 30 minutes. Flex sig should be next monday. I haven't had the flex sig in a long time, had colonoscopy in july though. Good luck tomorrow!
Proctitis DX 1999, Pancolitis DX 2008
Lialda 3 day
Immuran
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA


Lonie
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Date Joined Feb 2005
Total Posts : 6448
   Posted 12/10/2008 10:12 AM (GMT -6)   
Yes, keep us updated on your results; it will be very interesting. TaylorB, my late husband and I both had UC too. Did your husband and you both meet and have UC? We never figured out how we both got UC...about three years apart..because it's not contagious.

Carol

Remicade - will have my 25th infusion on November 26 
Vitamin B-12/Biotin, Probiotics
 
Co-Moderator for the UC Forum
 
 


TaylorB
Regular Member


Date Joined Jun 2007
Total Posts : 76
   Posted 12/10/2008 12:10 PM (GMT -6)   

yes let's keep track of each other...especially since we will apparently be starting this at almost the exact same time.  the administrator has told me that we would know the with the first shot if we are getting the drug (over placebo)  I am very reluctant to do this....just fear.  no other reason.

Loneylane,  i am sorry about your husband.  my husband and i both got UC while we were together.  also about 3 years apart.  we have no idea how and it is very unusual because as you say it is not contageous.  i have read on healing well how many think it is a drinking water thing. 

i just hate UC.

 

 


Lonie
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Date Joined Feb 2005
Total Posts : 6448
   Posted 12/10/2008 12:18 PM (GMT -6)   
Hmmm, I have to wonder Taylor. Are you located in the US? I'm in Sac California. I often wonder if we contracted it through contaminated water.

Carol

Remicade - will have my 25th infusion on November 26 
Vitamin B-12/Biotin, Probiotics
 
Co-Moderator for the UC Forum
 
 


TaylorB
Regular Member


Date Joined Jun 2007
Total Posts : 76
   Posted 12/10/2008 12:56 PM (GMT -6)   
we have lived in south east (appalachian) ohio for the past 13 years.  this is where i got sick.  we were living in north carolina when my husband started gettting sick. 

bbc
Veteran Member


Date Joined Mar 2008
Total Posts : 1580
   Posted 12/10/2008 1:02 PM (GMT -6)   
There appears to be a definite tie between TNF protiens and IBD so hopefully this will show promise without unwanted side effects.
Moderate Pancolitis
Dx'd 05/2007
7 Pentasa per day (4/3)
Corti Foam p.m. 2X per week
Prebiotics and Probiotics, Bowel Soother, Fish Oil, Calcium, Multi Vitamin and Melatonin
Trying to reduce sugar in my diet but cannot tolerate artificial sweetners
I excersice daily
Did I happen to mention I HATE this disease!!!


pb4
Elite Member


Date Joined Feb 2004
Total Posts : 20577
   Posted 12/11/2008 1:38 AM (GMT -6)   
How exciting Dr-A, I hope you get the med and not the placebo and I hope it works like a charm for you...definitely keep us posted on this.

:)
My bum is broken....there's a big crack down the middle of it! LOL :)


Dr-A
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Date Joined Jul 2006
Total Posts : 2105
   Posted 12/14/2008 5:35 PM (GMT -6)   
Prep today, sig scope tomorrow, 12 hour seminar have to go to tue, then first injection on Wed. Fun Fun!! All the while I just strained a rhomdoid bouncing the baby this morning, lol.
Proctitis DX 1999, Pancolitis DX 2008
Lialda 3 day
Immuran
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA


Dr-A
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Date Joined Jul 2006
Total Posts : 2105
   Posted 12/15/2008 4:36 PM (GMT -6)   
So, after a proper rectal probing today, my doc let me know if I didn't get better within two weeks of the first infusion I can be put on the drug for real without wondering if I am on saline or golimumab. That's nice to know. I am assuming you two will have same option?
Proctitis DX 1999, Pancolitis DX 2008
Lialda 3 day
Immuran
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA


Dr-A
Veteran Member


Date Joined Jul 2006
Total Posts : 2105
   Posted 12/17/2008 2:17 PM (GMT -6)   
In infusion lab. Long process waiting, just gotta finish up being watched. Rather funny we formed a choir and are singing christmas carols........
Proctitis DX 1999, Pancolitis DX 2008
Lialda 3 day
Immuran
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA


Lonie
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Date Joined Feb 2005
Total Posts : 6448
   Posted 12/17/2008 2:21 PM (GMT -6)   
Love it! That's too funny, but great way to make the time pass! What Christmas Carols did you sing? :-)

Carol

Remicade - will have my 25th infusion on November 26 
Vitamin B-12/Biotin, Probiotics
 
Co-Moderator for the UC Forum
 
 


Dr-A
Veteran Member


Date Joined Jul 2006
Total Posts : 2105
   Posted 12/17/2008 4:15 PM (GMT -6)   
All of them, lol. One of the nurses actually kept printing off all the words for all of us. I don't know what the other infusion labs are like, but Vanderbilts is a hoot.
Proctitis DX 1999, Pancolitis DX 2008
Lialda 3 day
Immuran
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA

Post Edited (Dr-A) : 12/17/2008 9:38:43 PM (GMT-7)


TaylorB
Regular Member


Date Joined Jun 2007
Total Posts : 76
   Posted 12/18/2008 8:26 AM (GMT -6)   

Hi Dr- A

So, after a proper rectal probing today, my doc let me know if I didn't get better within two weeks of the first infusion I can be put on the drug for real without wondering if I am on saline or golimumab. That's nice to know. I am assuming you two will have same option?


i think you were talking to me when you asked the above....i have heard that if you go thru the first 6 weeks, and it is obvious that you were on a placebo, that you will for sure be on the study drug for the 2nd part of the study that lasts for the next 54 weeks.  although my sister works for a drug company and she is a study investigator...she read my study documents, which were 19 pages long, and says that it actually isnt a sure thing...but for right now, i have heard that we will know on the first day if we are getting drug or placebo.   remember that we will be getting the drug in a shot form, not IV infusion. 

lastly i wanted to say that our trial for the first 6 weeks is double blind.  no one including the doctor knows who is getting the actual drug.(75%) get the drug 25% get placebo.  so there would be no way to get the real drug after 2 weeks if you dont respond. 

so you are in nashville? 

 

taylor


Dr-A
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Date Joined Jul 2006
Total Posts : 2105
   Posted 12/18/2008 8:51 PM (GMT -6)   
Scratchy throat all morning and throughout the day. Fine yesterday. Doubled up Vitamin C, green tea and manuka honey. Added in some colloidial silver..... Maybe coincidence, or may just be trying to get sore throat. Three BM's this morning.

Yeah, in Nashville. No idea about the 2 week thing. Just going on what the main GI doc told me. He heads research for IBD at vandy. Wonder why some are iv and some are sq?
Proctitis DX 1999, Pancolitis DX 2008
Lialda 3 day
Immuran
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA


Dr-A
Veteran Member


Date Joined Jul 2006
Total Posts : 2105
   Posted 12/22/2008 9:22 PM (GMT -6)   
Ah, the stress will test this. Of course I posted in another thread what happened. 3rd day I was on the can most of day, 22 trips!!!! GOOD LORD! 3 next day, 14 or so today.
Proctitis DX 1999, Pancolitis DX 2008
Lialda 1 day
Immuran
Golimumab study
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA


ElizaLily
Regular Member


Date Joined Dec 2008
Total Posts : 34
   Posted 12/23/2008 1:28 AM (GMT -6)   
Hi TaylorB,

I've had UC for over 20 years (diagnosed at 18). I'm in the midst of the worst flare ever. My gastro suggested the Golimumab study. I've been in it for several weeks. I am hoping that for the first part of the study I was given placebo because nothing happened. You mentioned that your administrator said you would know if you were given placebo- how would you know that?... I'm so curious to know if I was on placebo. So far in the second part of the study I know I have received 2 doses of the real drug but nothing has happened. I'm getting discouraged but the nurse said that she conferenced with other administrators involved in the study and they said they are finding that it takes 3-4 doses for benefits to kick in. Have you heard this - has anyone heard this or experienced it? I would really like to stay in touch and get your updates. I hope to god this thing works. What a pain in the ass this disease is!! I'm in Toronto by the way...

ElizaLily

TaylorB
Regular Member


Date Joined Jun 2007
Total Posts : 76
   Posted 12/23/2008 12:52 PM (GMT -6)   

eliza lily, (and dr a)

first, i was so sorry to read that dr a was doing worse after a promising weekend. 

we got our shots yesterday.  i guess that the guy was saying that some patients reported feeling better in short order-maybe a day or two, but maybe like dr a?? 

Eliza lily, what did you during the 6 weeks that you (now) think you were on placebo?  my husband is going to the bathroom between 12 and 18 times a day.  he cant make it six more weeks without relief. (he cant even make it another week at his pace) it he doesnt start to get some improvement we will have to do something else.  what did you do?  you said you were in a bad flair.  were you taking any other drugs?  or are you seeing some improvement?

 

 

 


Dr-A
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Date Joined Jul 2006
Total Posts : 2105
   Posted 12/23/2008 2:32 PM (GMT -6)   
Eh, seeing as how I will have no insurance now, I will stay with this as long as possible. At least all my GI visits/scopes/travel will be paid for. My next visit is on the 30th. One trip to toilet today, and that will probably be it. How do we get re-imbursed for the travel anyway? Anyone asked yet? Says in the notes can get up to 50$ per visit.

I think I got some sort of dosage of the stuff, just for the fact I had a scratchy throat for two days following. How were you and your hubby's shots? Hurt? Take Long?
Proctitis DX 1999, Pancolitis DX 2008
Lialda 1 day
Immuran
Golimumab study
Vitamin E Enemas as needed
Probiotis/GreenTea/VitD+Ca/SuperDHA


TaylorB
Regular Member


Date Joined Jun 2007
Total Posts : 76
   Posted 12/23/2008 3:28 PM (GMT -6)   

you had 22 trips to the bathroom yesterday and only 1 today?  wowza!  that is weird.

our reimbursement is 375.00 for the first part of the trial .  which is split up into at least 8 or 9 visits.  that includes everything. 

i think there is money to stay with the study after the first part (another 54 weeks) but i dont know right now what it is. 


ElizaLily
Regular Member


Date Joined Dec 2008
Total Posts : 34
   Posted 12/23/2008 4:51 PM (GMT -6)   
Hi TaylorB,

Sorry to hear about your husband. I seem to be going to the bathroom about the same as him- 15- 20+ a day. The first 6 weeks in the study were the same, that's why I think (I hope) I was given placebo. But now I'm not sure because even after 2 doses of actual meds, I'm not feeling a whole lot better. Through the study, I've been on 1 6MP, 4 Salofalk and 1 Prednisone a day. Nothing seems to be making a difference. Maybe there is a marginal difference but I'm still running to the bathroom and my hemoglobin is low - 84 or around that but maybe there is a little less blood when I go to the bathroom. The nurse told me she heard it takes 3-4 doses to see a difference. I hope she's right! Where are you in the study - still in the first phase or further along like me? I'm so glad I can be in touch with you guys and see how you're doing. I hope I have good news for you soon so you can look forward to feeling better...
Eliza

Paul L
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Date Joined Dec 2005
Total Posts : 647
   Posted 12/24/2008 12:51 AM (GMT -6)   
ElizaLily, I also live in Toronto (Scarborough). What hospital are you doing the study? I participated in 2 clinical studies at Mount Sinai Hospital. There is really no way to know for sure that you were on the placebo or not until they tell you once the study is over. Both of the studies I was in I didn’t respond to the treatment and had no side effects at all. I thought I was on the placebo both times. I was able to have the real treatment for both after 2 months and a sigmoidoscopy. When I got the real treatment for both studies nothing happened. It felt exactly the same as before. It turned out I had the placebo in the first study but I still don’t know if I had it in the second study. They won’t tell me until the entire study at all locations across North America are complete and all data has been analyzed.
Paul
Diagnosed in 2000 at age 43 with UC. Colon removed October 20/08.
Bad reaction to Asacol, Pentasa and Dipentum - can’t take any more 5ASAs.
Prednisone - worked well for 1 month, then side effects became unbearable.
6-MP - blood tests showed not metabolizing properly.
Corticosteroid enema, Flagyl, Ciprofloxin, VSL#3, Adacolumn Apheresis – no effect
Methotrexate with Remicade - 7 infusions with no improvement
Folic Acid and B12 injections.
Abatacept trial - no effect
Visit our photo albums at: http://www.laflammefamily.ca 


TaylorB
Regular Member


Date Joined Jun 2007
Total Posts : 76
   Posted 12/24/2008 9:21 AM (GMT -6)   
Eliza Lily,
Well, on the first day, (the day he was given the shot) my husband reported 11 BM's and no bright red blood which represented a big difference. Today he says he didn't wake up to go to the bathroom last night at all and has gone twice this morning but expects to go more, but this also represents being way behind the "normal" schedule.
my feeling is that if he is having the placebo effect, it should wear off by the end of the day, i will keep you posted.
we are driving out of town today and i wont have access to email until friday. so i will update then.
as for myself, i havent been to the bathroom yet. that could be normal for me as i only get sick every 2nd or third day. (i went off all meds over a year ago, since being off drugs, i have consistantly been sick only every 2nd or 3rd day in stead of everyday when i was on drugs, weird, but i was on every drug known at the time for 6 years and never ever got better for even one day)
anyway i expect to go today...and like i said will post later in the week. i am so sorry you havent had any relief. i had to be transfused form low hemoglobin twice...so watch that.
and paul from toronto, are you saying you have had your colon removed, but still take drugs?
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