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

NCT00445939 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-06-27

Study results available
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Summary

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

Interventions

BIOLOGICAL

adalimumab

160 mg at Week 0, 80 mg at Week 2

BIOLOGICAL

adalimumab

80 mg at Week 0, 40 mg at Week 2

BIOLOGICAL

placebo

Placebo at Week 0 and Week 2

Sponsors & Collaborators

  • Abbott Japan Co.,Ltd

    collaborator INDUSTRY

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Morio Ozawa · Abbott Japan Co.,Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00445939 on ClinicalTrials.gov