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Arlington Heights, Illinois

  • Crohn's Disease


Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)


Inclusion: - Diagnosis of Crohn's disease - CDAI score at baseline of between 220 and 450 - Normal laboratory parameters - Willing and able to give informed consent Exclusion: - Diagnosis of ulcerative colitis - Women cannot be pregnant or breastfeeding - No previous use of infliximab or other anti-TNF antagonists - No previous history of tuberculosis or listeria infection - No previous history of cancer other than successfully treated skin cancer

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 2



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:Stephen B Hanauer, MD
Principal Investigator
University of Chicago Department of Medicine

Study Dates

Start Date:April 2002
Verification Date:August 2006
Last Changed Date:August 11, 2006
First Received Date:March 4, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:comparison of the induction of clinical remission
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Adalimumab (D2E7)

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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