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

• Status: Completed
• Trial end date: 2020-01-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Adalimumab

Criteria

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).