Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
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ClinicalTrials.gov Identifier: NCT00105300 |
Recruitment Status :
Completed
First Posted : March 14, 2005
Last Update Posted : August 15, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: Adalimumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab |
Study Start Date : | October 2004 |

- Induction of clinical remission (CDAI score < 150 at Week 4)
- Clinical response measured as
- Decrease in Baseline CDAI score >= 70 points at Week 4
- Decrease in Baseline CDAI score >= 100 points at Week 4
- Changes in IBDQ scores at Week 4

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
- Normal lab parameters
- Are willing to give informed consent
- Have previously used and either were intolerant to or lost response to infliximab
Exclusion Criteria:
- History of certain types of cancer
- Diagnosis of ulcerative colitis
- Pregnant female or breast feeding subjects
- Known obstructive strictures
- Surgical bowel resection in the past 6 months
- History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
- History of poorly controlled medical conditions
- Specific doses and durations of Crohn's medications
- Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab

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): NCT00105300

Study Director: | Global Medical Information 1-800-633-9110 | Abbott |
ClinicalTrials.gov Identifier: | NCT00105300 |
Other Study ID Numbers: |
M04-691 |
First Posted: | March 14, 2005 Key Record Dates |
Last Update Posted: | August 15, 2006 |
Last Verified: | August 2006 |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |