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

This study is currently recruiting patients.

Sponsored by: Elan Pharmaceuticals
Biogen Idec
Information provided by: Elan Pharmaceuticals

Purpose

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

Condition Treatment or Intervention Phase
Crohn's Disease
  Drug: Antegren(TM) (natalizumab)
 Phase III

MedlinePlus related topics:  Crohn's Disease

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  462

Study start: February 2004

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria


Location and Contact Information


Arizona
      Advanced Clinical Therapeutics, Tucson,  Arizona,  85712,  United States; Recruiting
Marcie Ford-Tarlton  520-323-9601    marcie@advancedtherapies.com 
Charles Krone, MD,  Principal Investigator

      Harmony Clinical Research, Oro Valley,  Arizona,  85739,  United States; Recruiting
Sandra Wilson  520-544-2971    harmonyclinical@comcast.net 
Craig Gross, MD,  Principal Investigator

California
      UCSF / Mt. Zion IBD Center, San Francisco,  California,  94115,  United States; Recruiting
Yelena Idomsky  415-353-7871    yelena.idomsky@ucsfmedctr.org 
Jonathan P. Terdiman, MD,  Principal Investigator

      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
Jamie Brit  310-423-8052    Jaime.Birt@cshs.org 
Stephan Targan, MD,  Principal Investigator

      Shared Medical Research Foundation, Tarzana,  California,  91356,  United States; Recruiting
Mark Diamond  818-344-6111    sharedmedical@hotmail.com 
Jeffrey E. Galpin, MD,  Principal Investigator

      Digestive Diseases Foundation, Los Angeles,  California,  90067,  United States; Recruiting
Jon Castillo  310-772-0757    jonsclinicalresearch@hotmail.com 
Herbert A. Rubin, MD,  Principal Investigator

      Advanced Clinical Research Institute, Anaheim,  California,  92801,  United States; Recruiting
Alicia Buenrostro, CRC  714-778-1300  Ext. 281    ABuenrostro@agmg.com 
Dennis S. Riff, MD,  Principal Investigator

      Community Clinical Trials, Orange,  California,  92868,  United States; Recruiting
Lynda Nevarez  714-835-1870    research@comclintri.com 
David B. Stanton, MD,  Principal Investigator

      David Geffen School of Medicine at UCLA, Division of Digestive Diseases, Los Angeles,  California,  90092-7019,  United States; Recruiting
Ian McGowan, MD, PhD.  310-206-3580    imcgowan@mednet.ucla.edu 
Ian McGowan, MD, PhD,  Principal Investigator

Colorado
      Rocky Mountain Clinical Research, Golden,  Colorado,  80401,  United States; Recruiting
James Friend  303-279-1550    jtfriend777@yahoo.com 
John S. Goff, MD,  Principal Investigator

      Arapahoe Gastroenterology, Littleton,  Colorado,  80120,  United States; Recruiting
Tammy Vincze  303-279-1550 
James Friend  303-279-1550 
Richard Hansen, MD,  Principal Investigator

      Lynn Institute of the Rockies, Colorado Springs,  Colorado,  80909,  United States; Recruiting
Shelly Cobb  719-636-3784    scobb@lhsi.net 
Abbass Shafii, MD,  Principal Investigator

Connecticut
      Center for Medical Research, LLC, Manchester,  Connecticut,  06040,  United States; Recruiting
Christine Cournoyer, RN  860-646-4400  Ext. 16    christinecmr@snet.net 
Jeffrey Breiter, MD,  Principal Investigator

District of Columbia
      Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo, Washington,  District of Columbia,  20010,  United States; Recruiting
Katura Fetterson  202-877-6837    krf@rxtrialsinc.com 
Julio Salcedo, MD,  Principal Investigator

Florida
      Shafran Gastroenterology Center, Winterpark,  Florida,  32789,  United States; Recruiting
Jonathan Decker, ARNP  407-629-8121    nursej1@msn.com 
Ira Shafran, MD,  Principal Investigator

      Malcolm Randall VA Medical Center, Gainesville,  Florida,  32608,  United States; Recruiting
Theresa Huber, RN, BSN  352-376-1611  Ext. 6942    theresa.huber2@med.va.gov 
John Valentine, MD,  Principal Investigator

      Waterside Clinical Research Services, Inc., West Palm Beach,  Florida,  33407,  United States; Recruiting
Rita Blalock, RN, CCRC  561-659-6543  Ext. 123    rblalock@watersidemedical.com 
Steven Krumholz, MD,  Principal Investigator

      Borland Groover Clinic, Jacksonville,  Florida,  32256,  United States; Recruiting
Linda Burton  904-680-0871    lburton@bgclinic.com 
Lawrence S. Goldberg, MD,  Principal Investigator

      Miami Research Associates, Inc., Miami,  Florida,  33173,  United States; Recruiting
Joann Sellati, RN, CCRC  305-598-3125    jsellati@miamiresearch.com 
Howard Schwartz, MD,  Principal Investigator

Georgia
      Atlanta Gastroenterology Associates, Atlanta,  Georgia,  30342,  United States; Recruiting
Meredith Monroe  404-257-9000    meredithmonroe@aol.com 
Douglas C. Wolf, MD,  Principal Investigator

Illinois
      University of Chicago Hospitals, Chicago,  Illinois,  60637,  United States; Recruiting
Cathleen Mulcahy  773-834-2713    cmulcahy@medicine.bsd.uchicago.edu 
Russell Cohen, MD,  Principal Investigator

Indiana
      Indianapolis Gastroenterology Research Foundation, Indianapolis,  Indiana,  46227,  United States; Recruiting
Betsy Glowinski, RN  317-865-2959    betsy_glowinski@hotmail.com 
Stephen Mahoney, MD,  Principal Investigator

      Outpatient Clinical Research Facility, Indianapolis,  Indiana,  46202-5250,  United States; Recruiting
Katie Keller, RN, CCRC  317-274-3989    kpkeller@iupui.edu 
Debra Helper, MD,  Principal Investigator

Kentucky
      University of Kentucky Medical Center, Lexington,  Kentucky,  40536,  United States; Recruiting
Whitney Sparks, RN  859-323-6423    wsparks@uky.edu 
Jeri Reynolds  859-323-6423    jzreyn0@uky.edu 
Willem deVilliers, MD,  Principal Investigator

      University of Louisville, Louisville,  Kentucky,  40202,  United States; Recruiting
Karen Beatty, RN  502-852-8539    karen.beaty@louisville.edu 
Gerald Dryden, MD,  Principal Investigator

Louisiana
      Drug Research Service, Inc., Metairie,  Louisiana,  70001,  United States; Recruiting
Catina Gordon-Oates  504-456-1433    catina@drsinc.net 
David Silvers, MD,  Principal Investigator

Maryland
      Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research, Chevy Chase,  Maryland,  20815,  United States; Recruiting
Susanna Milton  301-652-5520    susannmilton@yahoo.com 
Robert Hardi, MD,  Principal Investigator

Minnesota
      Minnesota Gastroenterology, P.A., Plymouth,  Minnesota,  55446,  United States; Recruiting
Karah Neisen  612-870-5594    kneisen@mngastro.com 
Robert McCabe, Jr., MD,  Principal Investigator

      Mayo Clinic, Rochester,  Minnesota,  55905,  United States; Recruiting
Resa Jeche  507-284-5908    jeche.resa@mayo.edu 
William J. Sandborn, MD,  Principal Investigator

New York
      Long Island Clinical Research Associates, LLP, Great Neck,  New York,  11021,  United States; Recruiting
Mary Mustac  516-466-1051    mmustac@liclinical.com 
Seymour Katz, MD,  Principal Investigator

      Rochester Institute for Digestive Diseases and Sciences, Inc., Rochester,  New York,  14607,  United States; Recruiting
Deborah Corcoran  585-399-7011    debbiecorcoran@ridds.org 
William Chey,  Principal Investigator

      New York Center for Clinical Research, Lake Success,  New York,  11042,  United States; Recruiting
Melissa Erdvig  516-326-2700 
David Erdvig, MD,  Principal Investigator

      Mount Sinai School of Medicine, New York,  New York,  10028,  United States; Recruiting
Carol Stamaty  212-249-1039    carol.stamaty@ibdresearch.com 
Daniel Present, MD,  Principal Investigator

North Carolina
      Asheville Gastroenterology Associates, Asheville,  North Carolina,  28801,  United States; Recruiting
Geoffrey Kitchingman  828-254-0881  Ext. 388    research@ashevillegastro.com 
William Harlan, MD,  Principal Investigator

      Charlotte Gastroenterology & Hepatology, PLLC., Charlotte,  North Carolina,  28207,  United States; Recruiting
Lori Sell, RN  704-375-9485    research@charlottegastro.com 
Emily Pollock, BS  704-375-9485    research@charlottegastro.com 
John S. Hanson, MD,  Principal Investigator

      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27012,  United States; Recruiting
Amy Landon  336-716-7792    alandon@wfubmc.edu 
Richard Bloomfeld, MD,  Principal Investigator

      Wake Research Associates, Raleigh,  North Carolina,  27612,  United States; Recruiting
Marion Peoples  919-781-2514    regulatory@wakeresearch.com 
Charles Barish, MD,  Principal Investigator

      University of North Carolina, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Dolly Walkup  919-843-8105    dwalkup@med.unc.edu 
Kim L. Isaacs, MD,  Principal Investigator

Ohio
      Consultants for Clinical Research, Inc., Cincinnati,  Ohio,  45219,  United States; Recruiting
Linda Magaw, COO  513-872-4549    lmagaw@ccrstudy.com 
Alan V. Safdi, MD,  Principal Investigator

      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Amy Knesebeck  216-444-8539    kneseba@ccf.org 
Bret Lashner, MD,  Principal Investigator

Oklahoma
      Oklahoma Foundation for Digestive Research, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Delena Barnes  405-271-4602  Ext. 51244    delena-barnes@ouhsc.edu 
Philip B. Miner, MD,  Principal Investigator

      Lynn Health Science Institute, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Tiffany A. Walsh, LPN  405-602-3939    twalsh@lhsi.net 
Mark Mellow, MD,  Principal Investigator

      Oklahoma Gastroenterology Associates, Tulsa,  Oklahoma,  74104,  United States; Recruiting
Susan Enderlin  918-747-7399    senderlin@researchsolutionscorp.com 
Harvey Tatum, MD,  Principal Investigator

Pennsylvania
      Allegheny Center for Digestive Health, Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
Sandy Brown  412-359-8923    sbrown@wpahs.org 
Paul Lebovitz, MD,  Principal Investigator

      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
Sandra Bingaman, RN  717-531-8108    sbingaman@psu.edu 
Jill P. Smith, MD,  Principal Investigator

Rhode Island
      Gastroenterology Associates, Providence,  Rhode Island,  02904,  United States; Recruiting
Sima Patel  401-274-4800    gastroresearch@yahoo.com 
Samir Patel, MD,  Principal Investigator

South Carolina
      Medical University of South Carolina - Digestive Disease Center, Charleston,  South Carolina,  29425,  United States; Recruiting
Rebekah Richardson  843-792-0595    richreb@musc.edu 
Brenda Hoffman, MD,  Principal Investigator

Tennessee
      Gastroenterology Center of the Midsouth, P.C., Memphis,  Tennessee,  38120,  United States; Recruiting
Kathy Wilson, RN  901-820-0090    kathyw@gicentermidsouth.com 
Ziad Younes, MD,  Principal Investigator

      Nashville Medical Research Institute, Nashville,  Tennessee,  37205,  United States; Recruiting
Amy Meiers  615-383-1727    amymeiers@nashvillemedicalresearch.com 
Ronald Pruitt, MD,  Principal Investigator

      Southeastern Clinical Research, Chattanooga,  Tennessee,  37403,  United States; Recruiting
Kim Vaughan, CCRC  423-778-6947 
Colleen M. Schmitt, MD,  Principal Investigator

      Summit Research Solutions, Memphis,  Tennessee,  38120,  United States; Recruiting
Amanda Fletcher  901-747-3630  Ext. 342    afletcher@sumres.com 
Lawrence Wruble, MD,  Principal Investigator

Texas
      Atilla Ertan, MD, PA, Houston,  Texas,  77030,  United States; Recruiting
Inci E. Ertan, PhD  713-794-0001    ieertan@tmh.tmc.edu 
Atilla Ertan, MD,  Principal Investigator

      Gastroenterology Clinic of San Antonio, P.A., San Antonio,  Texas,  78229,  United States; Recruiting
Carlo M. Taboada, MA  210-615-3848    gcsa2004@yahoo.com 
Charless W. Randall, MD,  Principal Investigator

      Austin Gastroenterology, PA, Austin,  Texas,  78745,  United States; Recruiting
Linda Salas  512-532-8028    lindas@austingastro.com 
Scott Becker, MD,  Principal Investigator

Utah
      Wasatch Clinical Research, Salt Lake City,  Utah,  84107,  United States; Recruiting
Karen George  801-288-0607    kgeorge@wasatch.crc.com 
Edward Eyring, MD,  Principal Investigator

Virginia
      Gastroenterology Associates of Tidewater, Chesapeake,  Virginia,  23320,  United States; Recruiting
Vickie Maine  757-547-0798    vickie@gatgi.com 
Pramod Malik, MD,  Principal Investigator

      Internal Medicine Associates, Danville,  Virginia,  24541,  United States; Recruiting
Trisha Jones  434-792-2339  Ext. 118    imadanville@aol.com 
Jack B. Spainhour, MD,  Principal Investigator

      UVA Health System, Charlottesville,  Virginia,  22908,  United States; Recruiting
Pat Marohn  434-924-0248    pem3w@virginia.edu 
Stephen Bickston, MD,  Principal Investigator

      McGuire DVAMC GI (111N), Richmond,  Virginia,  23249,  United States; Recruiting
Edie Gavis, RN  804-675-5584    edith.gavis@med.va.gov 
William M. Pandak, MD,  Principal Investigator

Washington
      Tacoma Digestive Disease Research Center, Tacoma,  Washington,  98405,  United States; Recruiting
Melissa Waldner  253-572-4704    mwaldner@tddc-tec.com 
Michael Priebe, MD,  Principal Investigator

      Virginia Mason Medical Center, Seattle,  Washington,  98101,  United States; Recruiting
William Spaulding  206-341-1786    gaswms@vmmc.org 
Richard Kozarek, MD,  Principal Investigator

Wisconsin
      Aurora Helath Care, Milwaukee,  Wisconsin,  53215,  United States; Recruiting
Peggy Hanson  414-649-5532    peggy.hanson@aurora.org 
David Dozer, MD,  Principal Investigator

      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Sheila Thierfelder  414-805-3823    sthierf@mcw.edu 
David Binion, MD,  Principal Investigator

Canada
      Chauq Hopital Du St. Sacrement, Quebec,  G1S 4L8,  Canada; Recruiting
Josee Emond  418-682-7511  Ext. 2839    pierre.pare@cha.quebec.qc.ca 
Pierre Pare, MD,  Principal Investigator

Canada, Alberta
      University of Calgary, Calgary,  Alberta,  T2N 4N1,  Canada; Recruiting
Vi Todd, RN  403-220-6014 
Remo Panaccione, MD,  Principal Investigator

      GI Research, Edmonton,  Alberta,  T5H 4B9,  Canada; Recruiting
Daphne Meyer  780-429-3050    giresearch@gastrodoc.org 
Denise Wishard  780-429-3050    giresearch@gastrodoc.org 
Robert Bailey, MD,  Principal Investigator

      University of Alberta, Edmonton,  Alberta,  T6G 2C8,  Canada; Recruiting
Sharon Appelman-Eszczuk  780-492-8602    sharon.appelman@ualberta.ca 
Richard Fedorak, MD,  Principal Investigator

Canada, British Columbia
      Liver and Intestinal Research Centre, Vancouver,  British Columbia,  V5Z 1H2,  Canada; Recruiting
Irene Wong  604-876-5122 
Frank Anderson, MD,  Principal Investigator

      St. Paul's Hospital, Vancouver,  British Columbia,  V6Z 1Y6,  Canada; Not yet recruiting
Bryan McDougall  604-682-2344  Ext. 62715    bmcdougall@providencehealth.bc.ca 
Robert Enns, MD,  Principal Investigator

Canada, Manitoba
      Health Sciences Center, Winnipeg,  Manitoba,  R3A 1R9,  Canada; Recruiting
Trish Rawsthorne  204-787-1643    prawsth@cc.manitoba.ca 
Shirley Chubey  204-787-1643 
Charles Bernstein, MD,  Principal Investigator

Canada, Nova Scotia
      Queen Elizabeth II Science Center, Halifax,  Nova Scotia,  B3H 1V7,  Canada; Recruiting
Jennifer Stewart  902-473-6694    jestewar@dal.ca 
Donald MacIntosh, MD,  Principal Investigator

Canada, Ontario
      Mount Sinai Hospital, Toronto,  Ontario,  M5G 1X5,  Canada; Recruiting
Shelley Mikolainis  416-586-4989    smikolainis@mtsinai.ca 
A. Hillary Steinhart, MD,  Principal Investigator

      Sunnybrook & Women's College Health Sciences Center, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting
Mary Morgan  416-480-4808    mary.morgan@swchsc.on.ca 
Lawrence Cohen, MD,  Principal Investigator

      McMaster University Medical Centre, Hamilton,  Ontario,  L8N 3Z5,  Canada; Recruiting
Marysia Donnelly  905-521-2100  Ext. 76597    donnelly@hhsc.ca 
John Marshall, MD,  Principal Investigator

Canada, Quebec
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada; Recruiting
Christina Aumais  514-934-1934  Ext. 43914    christina.aumais@muhc.mcgill.ca 
Gary Wild, MD,  Principal Investigator

More Information

Study ID Numbers:  ELN100226-CD307
Record last reviewed:  September 2004
Record first received:  March 1, 2004
ClinicalTrials.gov Identifier:  NCT00078611
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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