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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
natalizumab
Sponsored by
Biogen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Digestive Disease Associates
  • Borland Groover Clinic
  • Atlanta Gastroenterology Associates
  • University of Kentucky Medical Center
  • Massachusetts General Hospital
  • Mercury Street Medical
  • Long Island Clinical Research Associates, LLP
  • Asheville Gastroenterology
  • Wake Research Associates
  • Boice-Willis Clinic
  • Columbia Gastroenterology Associates
  • Gastroenterology Center of the MidSouth
  • Memphis Gastroenterology Group
  • Austin Gastroenterology
  • Internal Medicine Associates
  • Gastroenterology Consultants
  • Virginia Mason Medical Center
  • Digestive Health Specialists

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 4, 2003
Last Updated
June 14, 2016
Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00055536
Brief Title
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
Collaborators
Elan Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
natalizumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Digestive Disease Associates
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Borland Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Asheville Gastroenterology
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Boice-Willis Clinic
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Columbia Gastroenterology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Gastroenterology Center of the MidSouth
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Austin Gastroenterology
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Internal Medicine Associates
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Gastroenterology Consultants
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Digestive Health Specialists
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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