Inflammatory Bowel Disease Clinical Trials

Patients coming to Cedars-Sinai for help with inflammatory bowel disease have easily accessible opportunities to participate in clinical trials and research. The doctors and scientists at Cedars-Sinai have made many pioneering discoveries in the field, developed new therapies for disease management, and are consulted by doctors around the world for their expertise in quickly bringing diagnostic and treatment advances out of the lab and into patient care plans.

Questions? See the Clinical Trials FAQs.

Condition:

Crohn's Disease

Key Inclusion Criteria

  • 18-75 years old
  • Documented diagnosis of Crohn’s disease with a minimum disease duration of 6 months, with involvement of the ileum and/or colon at a minimum
  • Moderately or severely active Crohn’s disease

Summary:

This study focuses on individuals diagnosed with Crohn’s disease, an inflammatory disease of the gastrointestinal tract (digestive tract). The purpose of the study is to determine whether an investigational drug called filgotinib is effective and safe for the treatment of moderate to severe Crohn’s disease. Researchers will compare different doses of filgotinib to a placebo (inactive substance) to learn which is more effective; participants will be randomly assigned to a study group. Biomarker testing will also be conducted. Biological markers (biomarkers) are substances in the body that can offer clues as to how the drug is affecting the body and a disease.

Condition:

Ulcerative Colitis

Key Inclusion Criteria

  • 18-75 years old
  • Documented diagnosis of ulcerative colitis of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge
  • Moderately to severely active ulcerative colitis

Summary:

This study focuses on patients diagnosed with ulcerative colitis, an inflammatory disease of the large intestines. The purpose of the study is to determine whether an investigational drug called filgotinib is effective and safe for the treatment of moderate to severe ulcerative colitis. Researchers will compare different doses of filgotinib to a placebo (inactive substance) to learn which is more effective; participants will be randomly assigned to a study group. Biomarker testing will also be conducted. Biological markers (biomarkers) are substances in the body that can offer clues as to how the drug is affecting the body and a disease.

Condition:

Crohn's Disease

Key Inclusion Criteria

  • At least 18 years old
  • Diagnosis of Crohn’s disease
  • In clinical remission

Summary:

This study focuses on patients who have well-controlled Crohn’s disease and low levels of Vitamin D. The purpose of the study is to determine the best strategy to maintain adequate Vitamin D levels in patients with Crohn’s disease who are in clinical remission. Although vitamin supplementation (consuming vitamins in addition to the nutrients in food eaten) is not approved by the Food and Drug Administration as treatment, it is routinely prescribed by physicians for support of bone health and nutrition. Studies have also found that low vitamin D levels are associated with poorer quality of life. Researchers will compare the effects of Vitamin D3 against the effects of a placebo (inactive substance); participants will be randomly assigned to a study group.

Condition:

Inflammatory bowel disease

Key Inclusion Criteria

  • Diagnosis of IBD
  • Family members of patients participating in the M.I.R.I.A.D. Biobank
  • Control subjects without IBD

Summary:

The purpose of the M.I.R.I.A.D. Biobank is to advance the understanding of inflammatory bowel diseases (IBD) and other inflammatory disorders. The Biobank collects specimens for immediate use in research studies and maintains specimens for future use. It also gathers information about donated samples from participants’ medical records. Specimens and health information are used in M.I.R.I.A.D. Biobank-supported investigations to improve the diagnosis and treatment of disease. Current and future uses of specimens may include genome sequencing, stem cell research and/or creation of cell lines.

Please see additional information regarding this study.

Condition:

Inflammatory bowel disease

Key Inclusion Criteria

  • At least 18 years old
  • Diagnosis of Crohn’s disease, ulcerative colitis or IBD undetermined
  • Accept conditions of informed consent
  • Affiliated with a participating IBD care site

Summary:

This study is designed as a program to collect health information from adults with inflammatory bowel disease (IBD) to better understand the disease and improve the quality of care for individuals living with IBD. The program will focus on a new way to manage IBD care, referred to as a dashboard, which will allow for more informed and productive communication between patients and providers.

Health information will be collected for quality improvement initiatives and research from three sources: medical records at the IBD Care Center, information that the provider enters into the dashboard, and information that the patient enters into the dashboard. Data will be maintained in a secure database