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.
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
Vitamin E Enemas as needed
Post Edited (Dr-A) : 12/9/2008 10:57:14 AM (GMT-7)