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

NCT00445432 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2012-02-02

Study results available
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Summary

To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.

Conditions

Interventions

BIOLOGICAL

adalimumab

Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)

OTHER

Placebo

Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)

Sponsors & Collaborators

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • Abbott

    lead INDUSTRY

Principal Investigators

  • Kazuko Kobayashi · Abbott

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
2007-03-31
Primary Completion
2009-03-31
Completion
2010-11-30

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 NCT00445432 on ClinicalTrials.gov