Expired Study
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Chicago, Illinois 60637


Purpose:

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)


Criteria:

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:

M02-403


NCT ID:

NCT00055523


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:

Completed


Study Phase:

Phase 2


Genders:

Both


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:

Abbott


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


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:comparison of the induction of clinical remission
Safety Issues:False
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

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: ClinicalTrials.gov

Date Processed: January 21, 2020

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