A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceratio

Phase 1

• Conditions: MedDRA version: 16.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; Crohn's disease

• Registration Number: EUCTR2013-001746-33-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1)Subject is between the ages of 18 to 75 years
2) Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period
3) Active CD with a Crohn's Disease Activity Index (CDAI) ? 220 and ? 450 despite treatment with oral corticosteroids and/or immunosuppressants
4) Mucosal ulceration on endoscopy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Subject with ulcerative colitis or indeterminate colitis
2) Subject who has had surgical bowel resections within the past 6 months or is planning resection
3) Subject with an ostomy or ileoanal pouch
4) Subject with bowel stricture or abdominal or peri-anal abscess
5) Subject who has short bowel syndrome
6) Chronic recurring infections or active TB

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified