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!


CADHUM

Calprotectin-directed Humira® maintenance therapy, a double-blind, double-dummy, randomized controlled trial for Crohn’s disease

Enrollment status: OPEN

Study Coordinator: Katy Weller

Drug: adalimumab (Humira®)

Patients who respond to Humira® often want to stop this drug once they get better. In this study, we are testing whether patients who are in remission on Humira® can stop their medicine and only be re-dosed if their inflammatory markers begin to increase. This requires following participants very closely, with fecal calprotectin/CRP testing every 3 months. We will also provide each patient with a Fitbit Charge HR™ to track their daily activity and sleep patterns. If there is a rise in the inflammatory markers, we will treat these patients with loading doses of Humira® before symptoms occur to see if we can prevent flares. We will also track daily heart rate, steps, and sleep patterns by providing patients with a Fitbit Charge HR™, and determine if there is a correlation between activity level and flare symptoms. The goal of this study is to see if you can treat patients with Humira® only when they need the medicine. If the study shows that Humira® can be used only when needed for Crohn’s disease, everyone with Crohn’s disease will benefit.


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: OPEN

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.


M14 – 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.