San Francisco, California 94117

  • 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)


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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:


Brief Title:

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

Official 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

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:

75 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:


Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Paul F Pollack, M.D.
Study Director

Study Dates

Start Date:July 2003
Verification Date:September 2007
Last Changed Date:September 23, 2007
First Received Date:February 12, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Clinical remission (CDAI<150).
Time Frame:56 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: March 30, 2020

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