A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Crohn's Disease

Treatments: Biological: adalimumab; Biological: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445939

M04-729

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Adalimumab 160 mg/80 mg

Experimental group

Treatment:

Biological: adalimumab

Biological: adalimumab

Adalimumab 80 mg/40 mg

Experimental group

Treatment:

Biological: adalimumab

Biological: adalimumab

Placebo

Placebo Comparator group

Treatment:

Biological: placebo