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-AT
• 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: 2014-05-15
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

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

Inclusion Criteria

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

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