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A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

NCT00853099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2014-09-05

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).

Conditions

Interventions

BIOLOGICAL

adalimumab

DRUG

placebo

Sponsors & Collaborators

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Morio Ozawa, MS · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-05-31
Completion
2013-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00853099 on ClinicalTrials.gov