A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT00078611

Collaborator

Elan Pharmaceuticals (Industry)

462

Enrollment

Locations

Duration (Months)

6.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: natalizumab	Phase 3

Detailed Description

Natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for Crohn's disease. It is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue. These cells are thought to cause damage to the bowel, leading to the symptoms of Crohn's disease. Elan Pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active Crohn's disease. Individuals with Crohn's disease will be randomly assigned to receive either placebo (an inactive solution) or natalizumab by intravenous infusion (this means putting it directly into a vein in the arm). There will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo. Participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals. Eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab. For those patients who do not enroll into the extension study, the total participation in this study will last for approximately 22 weeks.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn's Disease With Elevated C-Reactive Protein

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Mar 1, 2005

Actual Study Completion Date :

Mar 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Males and females 18 years of age or older
Diagnosis of Crohn's disease for at least 6 months
Females must not be pregnant or breastfeeding
Must not have previously taken natalizumab
Use of some other Crohn's disease medications is permitted, but will be closely supervised

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harmony Clinical Research	Oro Valley	Arizona	United States	85739
2	Advanced Clinical Therapeutics	Tucson	Arizona	United States	85712
3	Advanced Clinical Research Institute	Anaheim	California	United States	92801
4	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
5	Digestive Diseases Foundation	Los Angeles	California	United States	90067
6	David Geffen School of Medicine at UCLA, Division of Digestive Diseases	Los Angeles	California	United States	90092-7019
7	Community Clinical Trials	Orange	California	United States	92868
8	UCSF / Mt. Zion IBD Center	San Francisco	California	United States	94115
9	Shared Medical Research Foundation	Tarzana	California	United States	91356
10	Lynn Institute of the Rockies	Colorado Springs	Colorado	United States	80909
11	Rocky Mountain Gastroenterology	Golden	Colorado	United States	80215
12	Arapahoe Gastroenterology	LIttleton	Colorado	United States	80120
13	Center for Medical Research, LLC	Manchester	Connecticut	United States	06040
14	Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo	Washington	District of Columbia	United States	20010
15	Malcolm Randall VA Medical Center	Gainesville	Florida	United States	32608
16	Borland Groover Clinic	Jacksonville	Florida	United States	32256
17	Miami Research Associates, Inc.	Miami	Florida	United States	33173
18	Waterside Clinical Research Services, Inc.	West Palm Beach	Florida	United States	33407
19	Shafran Gastroenterology Center	Winterpark	Florida	United States	32789
20	Atlanta Gastroenterology Associates	Atlanta	Georgia	United States	30342
21	University of Chicago Hospitals	Chicago	Illinois	United States	60637
22	Outpatient Clinical Research Facility	Indianapolis	Indiana	United States	46202-5250
23	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana	United States	46227
24	University of Kentucky Medical Center	Lexington	Kentucky	United States	40536
25	University of Louisville	Louisville	Kentucky	United States	40202
26	Drug Research Service, Inc.	Metairie	Louisiana	United States	70001
27	Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research	Chevy Chase	Maryland	United States	20815
28	Minnesota Gastroenterology, P.A.	Plymouth	Minnesota	United States	55446
29	Mayo Clinic	Rochester	Minnesota	United States	55905
30	Long Island Clinical Research Associates, LLP	Great Neck	New York	United States	11021
31	New York Center for Clinical Research	Lake Success	New York	United States	11042
32	Mount Sinai School of Medicine	New York	New York	United States	10028
33	Rochester Institute for Digestive Diseases and Sciences, Inc.	Rochester	New York	United States	14607
34	Asheville Gastroenterology Associates	Asheville	North Carolina	United States	28801
35	University of North Carolina	Chapel Hill	North Carolina	United States	27599
36	Charlotte Gastroenterology & Hepatology, PLLC.	Charlotte	North Carolina	United States	28207
37	Wake Research Associates	Raleigh	North Carolina	United States	27612
38	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27012
39	Consultants for Clinical Research, Inc.	Cincinnati	Ohio	United States	45219
40	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
41	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma	United States	73104
42	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
43	Oklahoma Gastroenterology Associates	Tulsa	Oklahoma	United States	74104
44	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
45	Allegheny Center for Digestive Health	Pittsburgh	Pennsylvania	United States	15212
46	Gastroenterology Associates	Providence	Rhode Island	United States	02904
47	Medical University of South Carolina - Digestive Disease Center	Charleston	South Carolina	United States	29425
48	Southeastern Clinical Research	Chattanooga	Tennessee	United States	37403
49	Gastroenterology Center of the Midsouth, P.C.	Memphis	Tennessee	United States	38120
50	Summit Research Solutions	Memphis	Tennessee	United States	38120
51	Nashville Medical Research Institute	Nashville	Tennessee	United States	37205
52	Austin Gastroenterology, PA	Austin	Texas	United States	78745
53	Atilla Ertan, MD, PA	Houston	Texas	United States	77030
54	Gastroenterology Clinic of San Antonio, P.A.	San Antonio	Texas	United States	78229
55	Wasatch Clinical Research	Salt Lake City	Utah	United States	84107
56	UVA Health System	Charlottesville	Virginia	United States	22908
57	Gastroenterology Associates of Tidewater	Chesapeake	Virginia	United States	23320
58	Internal Medicine Associates	Danville	Virginia	United States	24541
59	McGuire DVAMC GI (111N)	Richmond	Virginia	United States	23249
60	Virginia Mason Medical Center	Seattle	Washington	United States	98101
61	Tacoma Digestive Disease Research Center	Tacoma	Washington	United States	98405
62	Aurora Helath Care	Milwaukee	Wisconsin	United States	53215
63	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
64	University of Calgary	Calgary	Alberta	Canada	T2N 4N1
65	GI Research	Edmonton	Alberta	Canada	T5H 4B9
66	University of Alberta	Edmonton	Alberta	Canada	T6G 2C8
67	Liver and Intestinal Research Centre	Vancouver	British Columbia	Canada	V5Z 1H2
68	St. Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 1Y6
69	Health Sciences Center	Winnipeg	Manitoba	Canada	R3A 1R9
70	Queen Elizabeth II Science Center	Halifax	Nova Scotia	Canada	B3H 1V7
71	McMaster University Medical Centre	Hamilton	Ontario	Canada	L8N 3Z5
72	Sunnybrook & Women's College Health Sciences Center	Toronto	Ontario	Canada	M4N 3M5
73	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5
74	Montreal General Hospital	Montreal	Quebec	Canada	H3G 1A4
75	Chauq Hopital Du St. Sacrement	Quebec		Canada	G1S 4L8