The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
- Conditions
- Crohn's DiseaseMedDRA version: 17.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2014-004560-38-Outside-EU/EEA
- Lead Sponsor
- Abbott Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 80
•Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450.
•If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
•Ulcerative colitis or indeterminate colitis
•History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV)
•Body weight is below 30 kg
•Surgical bowel resections within the past 6 months
•Females who are pregnant or breast-feeding or considering becoming pregnant during the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method