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

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00077779

First received: February 12, 2004

Last updated: September 23, 2007

Last verified: September 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

February 12, 2004

Last Updated Date

September 23, 2007

Start Date ^ICMJE

July 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Clinical remission (CDAI<150). [ Time Frame: 56 weeks ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00077779 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Crohn's Disease

Intervention ^ICMJE

Drug: Adalimumab

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

854

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00077779

Other Study ID Numbers ^ICMJE

M02-404

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Paul F Pollack, M.D.

Abbott

Information Provided By

Abbott

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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