Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
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| ClinicalTrials.gov Identifier: NCT00032799 |
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Recruitment Status :
Completed
First Posted : April 4, 2002
Last Update Posted : June 16, 2016
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Sponsor:
Biogen
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | April 3, 2002 | ||
| First Posted Date ICMJE | April 4, 2002 | ||
| Last Update Posted Date | June 16, 2016 | ||
| Study Start Date ICMJE | December 2001 | ||
| Actual Primary Completion Date | September 2003 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE | Not Provided | ||
| Original Primary Outcome Measures ICMJE | Not Provided | ||
| Change History | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease | ||
| Official Title ICMJE | A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease | ||
| Brief Summary | The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderately to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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| Condition ICMJE | Crohn's Disease | ||
| Intervention ICMJE | Drug: natalizumab | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Sandborn WJ, Colombel JF, Enns R, Feagan BG, Hanauer SB, Lawrance IC, Panaccione R, Sanders M, Schreiber S, Targan S, van Deventer S, Goldblum R, Despain D, Hogge GS, Rutgeerts P; International Efficacy of Natalizumab as Active Crohn's Therapy (ENACT-1) Trial Group; Evaluation of Natalizumab as Continuous Therapy (ENACT-2) Trial Group. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med. 2005 Nov 3;353(18):1912-25. doi: 10.1056/NEJMoa043335. Erratum In: N Engl J Med. 2015 May 21;372(21):2074. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Actual Enrollment ICMJE |
905 | ||
| Original Enrollment ICMJE | Not Provided | ||
| Actual Study Completion Date ICMJE | September 2003 | ||
| Actual Primary Completion Date | September 2003 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderately to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during the study. | ||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00032799 | ||
| Other Study ID Numbers ICMJE | CD301 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Current Responsible Party | Biogen | ||
| Original Responsible Party | Not Provided | ||
| Current Study Sponsor ICMJE | Biogen | ||
| Original Study Sponsor ICMJE | Elan Pharmaceuticals | ||
| Collaborators ICMJE | Elan Pharmaceuticals | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Biogen | ||
| Verification Date | March 2012 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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