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Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

NCT00105300•Abbott

View on ClinicalTrials.gov

Summary

The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI \[Crohn's Disease Activity Index\] score of 220 and 450)
•Normal lab parameters
•Are willing to give informed consent
•Have previously used and either were intolerant to or lost response to infliximab

Exclusion Criteria

•History of certain types of cancer
•Diagnosis of ulcerative colitis
•Pregnant female or breast feeding subjects
•Known obstructive strictures
•Surgical bowel resection in the past 6 months
•History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
•History of poorly controlled medical conditions
•Specific doses and durations of Crohn's medications
•Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab

Locations (56)

Clinical Research Associates

Huntsville, Alabama, United States

Capitol Gastroenterology Consultants Medical Group, Inc.

Roseville, California, United States

Medical Associates Research Group

San Diego, California, United States

Sharp Rees-Stealy Medical Group

San Diego, California, United States

SMC-Trauma Research

Englewood, Colorado, United States

Clinical Research of West Florida, Inc

Clearwater, Florida, United States

V.A. Medical Center

Gainesville, Florida, United States

Borland-Groover Clinic

Jacksonville, Florida, United States

Shafran Gastroenterology Center

Winter Park, Florida, United States

Pinnacle Trials, Inc.

Atlanta, Georgia, United States

Key Dates

Start Date

October 1, 2004

Last Updated

August 15, 2006

Enrollment

300

Estimated participants

Conditions

Crohn's Disease

Interventions

Adalimumab

DRUG

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

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

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: August 15, 2006Data 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

Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in 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

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

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