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

  • Interventional
  • Not Recruiting
  • NCT02065570
Eligibility Details Visit Clinicaltrials.gov

A Multicenter, Randomized, Double-Blind Study to 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

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.

Gender
All

Age Group
18 Years to 75 Years

Accepting Healthy Volunteers?
No

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).

At a Glance

National Government IDNCT02065570

IRB#IRB14-1095

Lead SponsorAbbVie

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Not Recruiting