A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease
Phase 1
- Conditions
- Crohn's diseaseMedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2013-004034-15-IT
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 252
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
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Week 40;Main Objective: The primary objective of this study is to evaluate the long-term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease (CD).;Secondary Objective: The secondary objective is to assess pharmacokinetics (PK) and immunogenicity of adalimumab following subcutaneous (SC) administration.;Primary end point(s): Proportion of subjects with endoscopic improvement at Week 40 among subjects with endoscopic improvement at Week 0 of Study M14-347.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): .;Timepoint(s) of evaluation of this end point: .