A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease

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: EUCTR2013-004034-15-DE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-29
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Subject successfully enrolled in and completed Study M14-115, including the Week 12 ileocolonoscopy.
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) If the Week 12 (Study M14 115) colonoscopy shows evidence of dysplasia or a malignancy.
2) Subject is not in compliance with prior and concomitant medication requirements throughout Study M14-115.
3) Subject who developed active Tuberculosis (TB) during Study M14-115, or subject who is non compliant with prophylaxis for latent TB initiated per Study M14-115 procedures.

Study & Design

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