Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects with Moderate to Severe Crohn's Disease

Overview

About this study

This study will 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.
Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
Mucosal ulceration on endoscopy.

Exclusion Criteria:

Subject with ulcerative colitis or indeterminate colitis.
Subject who has had surgical bowel resections in the past 6 months or is planning resection.
Subjects with an ostomy or ileoanal pouch.
Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
Subject who has short bowel syndrome.
Chronic recurring infections or active Tuberculosis (TB).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Edward Loftus, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials