Golimumab Study Starting

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.

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.

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.

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.

There appears to be a definite tie between TNF protiens and IBD so hopefully this will show promise without unwanted side effects.

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.

In infusion lab. Long process waiting, just gotta finish up being watched. Rather funny we formed a choir and are singing christmas carols........

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.

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?

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

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?

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

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?