A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00055523 |
Recruitment Status
:
Completed
First Posted
: March 6, 2003
Last Update Posted
: August 15, 2006
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: Adalimumab (D2E7) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | April 2002 |

- comparison of the induction of clinical remission
- (achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055523

Principal Investigator: | Stephen B Hanauer, MD | University of Chicago Department of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00055523 History of Changes |
Other Study ID Numbers: |
M02-403 |
First Posted: | March 6, 2003 Key Record Dates |
Last Update Posted: | August 15, 2006 |
Last Verified: | August 2006 |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Antibodies Adalimumab Immunologic Factors Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |