Clinical trial NCT00055536: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2003-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Digestive Disease Associates
state: Florida
city: Jacksonville
country: United States
facility: Borland Groover Clinic
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice-Willis Clinic
state: North Carolina
city: Columbia
country: United States
facility: Columbia Gastroenterology Associates
state: South Carolina
city: Memphis
country: United States
facility: Gastroenterology Center of the MidSouth
state: Tennessee
city: Memphis
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology
state: Texas
city: Danville
country: United States
facility: Internal Medicine Associates
state: Virginia
city: Virginia Beach
country: United States
facility: Gastroenterology Consultants
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Tacoma
country: United States
facility: Digestive Health Specialists
state: Washington
Study officials:
References: