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

COMPLETEDPHASE2/PHASE3

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

A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

NCT00445939•Abbott

View on ClinicalTrials.gov

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.

Eligibility

Age

15 - 75 years

Sex

ALL

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

Locations (18)

Aichi, Japan

Chiba, Japan

Ehime, Japan

Fukuoka, Japan

Hiroshima, Japan

Hokkaido, Japan

Hyōgo, Japan

Kagawa, Japan

Kanagawa, Japan

Kochi, Japan

Key Dates

Start Date

February 1, 2007

Primary Completion Date

December 1, 2007

Last Updated

June 27, 2011

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

adalimumab

BIOLOGICAL

adalimumab

BIOLOGICAL

placebo

BIOLOGICAL

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

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Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease