Crohn's Disease Treatment Studies

If you are looking for clinical trials for Crohn's disease you have come to the right place! As researchers, our goal is to discover new therapies and information about Inflammatory Bowel Disease (IBD), but most importantly, provide an alternate therapy that helps YOU. We welcome you to the IBD Research Team and encourage you to look at the studies below that you may qualify for. We will update this site periodically, so keep checking this page for new studies. If you have ANY questions or are interested in participating please feel free to call (734) 615-4843 or e-mail higginsSCteam@umich.edu. We hope to hear from you soon!


Celltrion

A randomized, double-blind, parallel-group, phase 3 study to demonstrate noninferiority in efficacy and to assess safety of CT-P13 compared to Remicade® in patients with active Crohn's disease

Enrollment status: OPEN

Study Coordinator: Kelli Porzondek

Drug: CT-P13 (generic Remicade®)

This is a phase 3 study for patients with moderate to severely active Crohn's disease to evaluate the  safety and effectiveness of CT-P13 (a generic form of Remicade®) versus Remicade®. Patients will be randomized to receive either CT-P13 or Remicade® (no placebo) at week 0. All patients will randomly be assigned to either continue on the original randomized drug for the entire study, or to switch therapies at week 30. Patients will be eligible to receive drug for up to 54 weeks.


Rifaximin RECD3125

A double-blind, placebo-controlled, parallel-group, multicenter, multiregional, one year study to assess the efficacy and safety of twice daily oral rifaximin delayed release tablets for induction of clinical remission with endoscopic response at 16 weeks followed by clinical and endoscopic remission at 52 weeks in subjects with active moderate Crohn's disease

Enrollment status: UPCOMING

Study Coordinator: Katy Weller

Drug: Rifaximin

This is a one year study to assess the efficacy and safety of twice daily oral rifaximin delayed-release (DR) tablets in subjects with active moderate Crohn's disease. Patients will be randomized in a 1:1 ratio at week 0 to either rifaximin DR tablets 800 mg twice daily or placebo. The treatment period will last up to 52 weeks and will assess clinical remission and endoscopic response.


SERENE CD

A multicenter, randomized, double-blind study to evaluate the efficacy and safety of two adalimumab induction regimens in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration

Enrollment status: OPEN

Study Coordinator: Karina Lizzi

Drug: HUMIRA®

This is a phase 3 study for subjects with moderately to severely active Crohn’s disease to evaluate the efficacy and safety of two HUMIRA® induction regimens followed by standard maintenance therapy with HUMIRA®. Patients are randomized in a 1:1 ratio to receive either the standard induction dose or the higher induction dose of HUMIRA® followed by HUMIRA® every other week for 12 weeks. All patients will then roll over into a maintenance phase and continue to receive HUMIRA® every other week for up to 40 weeks.


Tofacitinib for Crohn's disease

A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn's disease

Enrollment status: OPEN

Study Coordinator: Kay Sauder

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

This is a phase 2b study of subjects with moderately to severely active Crohn's disease. 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 in the case of anti-TNF or interleukin-6 blockers. It is taken in pill form.

The study lasts 8 weeks and involves a screening visit, a week 0/baseline appointment, follow-up visits at week 2, week 4, and week 7 to assess response to the medicine. Finally, at week 8, 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 26 weeks and then the open-label extension study, meaning there is no placebo and you are guaranteed active drug.