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Inflammatory Bowel Disease Program

Overview

double helix

In 2001, the Yale Inflammatory Bowel Disease Program was specifically formed to answer the challenges faced by patients with the complex, lifelong gastrointestinal, inflammatory diseases of Crohn's Disease and ulcerative colitis. Our program focuses on three components: Clinical Services, Patient Education, and Research.

Research

Yale University is one of six genetic research centers created by the National Institute of Diabetes, Digestive and Kidney diseases (NIDDK) seeking to advance the discovery of genes influencing an individuals’ risk for developing Crohn’s disease and ulcerative colitis.

Here at the Yale IBD Program, we believe research is an integral component of achieving the highest quality care. The Yale IBD Program is uniquely suited to offer state of the art research to the patients who are evaluated. Both clinicians and researchers work together for the patient’s best interest. For us, the goal of research is three-fold: to improve clinical therapy, to improve patient outcomes, and to increase our understanding of the disease. Our research interests and studies fall into two categories, Clinical and Translational. All research is approved through Yale Institutional Review Board (IRB).

Clinical Trials

Frequently Asked Questions

1. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral CP-690,550 as an Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (UC)

Tofacitinib Induction

The purpose of this research study is to compare the effects of CP-690,550 (Tofacitinib) to a placebo in patients with ulcerative colitis in inducing remission. CP-690,550 blocks a group of enzymes (janus kinases), which act like a gate into the cells of the immune system. By blocking these enzymes, the cells of the immune system are expected to produce fewer chemicals believed to cause bowel inflammation in UC. In order to be eligible for this study, participants must be 18 years of age, have a diagnosis of UC for greater than 4 months, have failed either oral corticosteroids, 6MP, Azathioprine, Humira or Remicade, and must meet other criteria which will be discussed at the screening visit. Eligible participants in this study will have a 4 in 5 (80%) chance of receiving CP-690,550. Based on the results of this study, participants may qualify to enter a maintenance or extension study.

Principal Investigator: Dr. Deborah Proctor. HIC #1211011128.

Status - Enrolling

2. A Multicenter, Open-Label Study of CP-690,550 in Subjects with Moderate to Severe Ulcerative Colitis (UC)

Tofacitinib Open Label
The purpose of this research study is to assess the long term safety, tolerability and effectiveness of CP-690,550 (Tofacitinib) in patients with ulcerative colitis. Participants must have been previously enrolled in the induction or maintenance study of Tofacitinib in order to be eligible. This is an open label study and all patients will receive either 5 mg or 10 mg CP-690,550 twice a day, depending on the status of their UC at the baseline visit.

Principal Investigator: Dr. Deborah Proctor. HIC #1211011130.

Status - Enrolling

3. A Multicenter, Open-Label Study of CP-690,550 in Subjects with Moderate to Severe Ulcerative Colitis (UC)
Tofacitinib Open Label

The purpose of this research study is to assess the long term safety, tolerability and effectiveness of CP-690,550 (Tofacitinib) in patients with ulcerative colitis. Participants must have been previously enrolled in the induction or maintenance study of Tofacitinib in order to be eligible. This is an open label study and all patients will receive either 5 mg or 10 mg CP-690,550 twice a day, depending on the status of their UC at the baseline visit.

Principal Investigator: Dr. Deborah Proctor. HIC #1211011130.

Status - Enrolling

4. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease (IMUNITI): Status - Closed to enrollment

Uste Maintenance
A study to determine whether treatment with ustekinumab (Stelara) improves symptoms of Crohn's disease over the long-term. This study especially focuses on how the response of the drug can be maintained in those who experienced improvement after the original treatment. Participants in this study must have first completed the induction study. Section one of this study will last 44 weeks from the first visit of this study and if a patient responds to treatment, he/she will be eligible to continue to receive study agent in a long term extension of up to 3 additional years.

Principal Investigator: Dr. Deborah Proctor. HIC #1106008632.

Status - Closed to enrollment

5. A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris suis Ova (TSO) Treatment in Left-Sided Ulcerative Colitis and its Effects on Mucosal Immune State and Microbiota

The purpose of this study is to evaluate the safety and effectiveness of TSO in ulcerative colitis. The investigators will look at how TSO affects the body’s immune response, and if there are changes in disease activity. 120 eligible subjects nationwide will be randomized to receive either 6 doses of 7500 TSO orally or 6 doses of placebo orally over a ten week period. In order to be eligible for this study, participants must be between the ages of 18-70 and have a confirmed diagnosis of ulcerative colitis (currently limited to the left colon) and must meet other criteria as well which will be discussed at the screening visit.

Principal Investigator: Deborah Proctor, MD, HIC#: 1307012399.

Status: Enrolling

Translational/Basic Research

Frequently Asked Questions

1. Genetics of Inflammatory Bowel Disease

Genetic information is analyzed to help us identify and better understand the way in which IBD manifests and how certain genetic traits contribute to this manifestation. Subjects from our study have already contributed to identifying over 30 genes that influence the development of IBD. Yale leads the NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC) of six universities. A short family history and small blood draw are required.

Principal Investigators: Drs. Deborah Proctor, and Clara Abraham. (HIC # 0607001669)

Status - Enrolling

2. IBD Immune Responses

Understanding changes of immune responses and immune pathways in patients with IBD. The goals of these projects are to define changes in expression of genes, and in immunological pathways and responses in patients with Crohn's disease and ulcerative colitis by examining immune cells from the blood and intestine of patients with IBD. Requires a small blood sample.

Principal Investigators: Dr. Clara Abraham and (HIC # 0607001669)

Status - Enrolling


To learn more about how we treat complex, lifelong inflammatory diseases through our dedicated program focused on clinical care, patient education and research please visit YaleMedicine.org.