Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thornton Hospital Reumatology Division, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of >= 220 and <= 450, normal laboratory parameters,
are willing and able to give informed consent, and
are able to self-inject or have a designee or healthcare professional who can inject the study medication.

Exclusion:

History of certain types of cancer, diagnosis of ulcerative colitis,
female or breast feeding subjects,
surgical bowel resection(s) with in the past 6 months,
history of listeria,
human immunodeficiency virus (HIV),
central nervous system demyelinating disease or untreated TB,
history of a poorly controlled medical condition,
unsuccessful response to infliximab or any anti-TNF agent use in the past.

Treatment and study plan

Adalimumab

Drug

Primary outcomes

Clinical remission (CDAI<150).

Time frame: 56 weeks

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

Acronym: CHARM

Important dates

Study start: 2003
First posted: Feb 16, 2004
Registry last updated: Sep 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed