A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceratio

Phase 1

• Conditions: Crohn's disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-001746-33-SK
• 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: 2014-04-15
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Subject is between the ages of 18 to 75 years
• Diagnosis of colonic, ileocolonic, or ileal Crohn's disease for = 3 months prior to Baseline and confirmed by endoscopy during the Screening period or endoscopy performed within 45 days before Baseline.
• Crohn's Disease Activity Index (CDAI) = 220 and = 450 at Baseline despite concurrent or prior treatment with a full oral corticosteroids and/or immunosuppressants

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 485
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

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

Study & Design

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