Ulcerative Colitis Treatment Studies

OCTAVE

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

Drug: Tofacitinib (CP-690,550) – oral medication

This is a Phase 3 study of subjects with moderately to severely active ulcerative colitis. The medicine is a JAK inhibitor made by Pfizer. JAK inhibition is a novel approach for treating a variety of autoimmune and inflammatory diseases. JAK inhibitors interrupt signaling downstream of a multiplicity of cytokines, rather than blocking one cytokine at a time, as occurs with anti-TNF or interleukin-6 blockers. It is taken in pill form.

The study lasts 9 weeks and involves a screening visit, a week 0/baseline appointment, and follow-up visits at week 2, week 4, and week 8 to assess response to the medicine. Finally, at week 9 we will assess the subject's eligibility to continue in the program. Those who complete the treatment period and meet the definition of clinical response or clinical remission will be eligible to enter a placebo-controlled maintenance study of 52 weeks (A3921096). Subjects who complete the treatment period but do not meet the definition of clinical response or remission will be eligible to enter an open-label extension study (A3921139), meaning there is no placebo and you are guaranteed active drug.

TURANDOT

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

Drug: PF-00547659 – injection under the skin

The TURANDOT Program is a clinical research study being conducted worldwide to test the effectiveness of PF-00547659 in treating ulcerative colitis (UC). PF-00547659 is being studied because it may decrease the inflammation and ulceration of UC by decreasing the attraction of white blood cells to the intestines and preventing the wearing away of healthy tissue in the colon.

If you decide to take part, you will first complete the induction phase. For this phase you will be asked to visit the study center 6 times over the 12-week study period. You will be asked to return to the site for these visits to complete a routine check-up and receive a dose of the study medicine, which will be an injection under the skin. Your visits will likely include laboratory tests (blood, urine, and stool), a weight check, and a physical examination. On some occasions, you may also need to complete forms or questionnaires.

If you complete this study, you will have the option to join the open-label phase of the study, which will allow access to the drug for up to 2 years. This will involve returning to the site every 4 weeks for an injection under the skin. There is no placebo involved in this portion of the study. You will be reimbursed $90 for each visit completed.

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