Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00055536
• Collaborator: Elan Pharmaceuticals (Industry)
• Enrollment: 60
• Locations: 18
• Duration (Months): 15
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. 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.

Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: natalizumab	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: Jul 1, 2003
• Actual Study Completion Date: Jul 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• Male and female patients at least 18 years of age with at least a six-month history of Crohn's disease and who are currently receiving Remicade and are not in remission (CDAI greater than/equal to 150)

• Women must not be breastfeeding or pregnant, and must not become pregnant during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Digestive Disease Associates	Gainesville	Florida	United States	32605
2	Borland Groover Clinic	Jacksonville	Florida	United States	32223
3	Atlanta Gastroenterology Associates	Atlanta	Georgia	United States	30342
4	University of Kentucky Medical Center	Lexington	Kentucky	United States	40536
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	Mercury Street Medical	Butte	Montana	United States	59701
7	Long Island Clinical Research Associates, LLP	Great Neck	New York	United States	11021
8	Asheville Gastroenterology	Asheville	North Carolina	United States	28801
9	Wake Research Associates	Raleigh	North Carolina	United States	27612
10	Boice-Willis Clinic	Rocky Mount	North Carolina	United States	27804
11	Columbia Gastroenterology Associates	Columbia	South Carolina	United States	29203
12	Gastroenterology Center of the MidSouth	Memphis	Tennessee	United States	38120
13	Memphis Gastroenterology Group	Memphis	Tennessee	United States	38120
14	Austin Gastroenterology	Austin	Texas	United States	78745
15	Internal Medicine Associates	Danville	Virginia	United States	24541
16	Gastroenterology Consultants	Virginia Beach	Virginia	United States	23455
17	Virginia Mason Medical Center	Seattle	Washington	United States	98101
18	Digestive Health Specialists	Tacoma	Washington	United States	98405

Sponsors and Collaborators

• Biogen
• Elan Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT00055536
• Other Study ID Numbers: CD306
• First Posted: Mar 6, 2003
• Last Update Posted: Jun 16, 2016
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Crohn Disease; Natalizumab

Study Results

No Results Posted as of Jun 16, 2016