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Crohn's Disease |
Crohn's disease; Crohn//'s disease; Inflamatory Bowel Disease; Inflammatory Bowel Disease, Crohn's |
Clinical Trial: Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Crohn's Disease
This study is currently recruiting patients.
|
Purpose
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Crohn's Disease | Drug: Adalimumab | Phase III |
MedlinePlus related topics: Crohn's Disease
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab
Further Study Details:
Expected Total Enrollment: 300
Study start: October 2004
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
- Normal lab parameters
- Are willing to give informed consent
- Have previously used and either were intolerant to or lost response to infliximab
Exclusion Criteria:
- History of certain types of cancer
- Diagnosis of ulcerative colitis
- Pregnant female or breast feeding subjects
- Known obstructive strictures
- Surgical bowel resection in the past 6 months
- History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
- History of poorly controlled medical conditions
- Specific doses and durations of Crohn's medications
- Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab
Location and Contact Information
Marie Nickle, BA 973-394-5513 marie.nickle@abbott.com
Alabama
Clinical Research Associates, Huntsville, Alabama, 35801, United States; Recruiting
Peg Rochine 256-536-6600 prochine@clinicalresearchassociates.biz
Allen Goetsch, MD, Principal Investigator
Allen Goetsch, MD, Principal Investigator
California
Medical Associates Research Group, San Diego, California, 92123, United States; Recruiting
Dianne Touhy 858-277-5678 dianne.tuohy@marginc.com
Michael Bennett, MD, Principal Investigator
Michael Bennett, MD, Principal Investigator
Sharp Rees-Stealy Medical Group, San Diego, California, 92123, United States; Recruiting
Catherine Goodwater 858-541-6594 Catherine.Goodwater@sharp.com
Bruce R Johnson, MD, Principal Investigator
Bruce R Johnson, MD, Principal Investigator
Capitol Gastroenterology Consultants Medical Group, Inc., Roseville, California, 95661, United States; Recruiting
Christy Bellamy-Pifer, B.S., CRC 609-407-1220 Cpifer@capitolgi.com
Theodor Feinstat, MD, Principal Investigator
Theodor Feinstat, MD, Principal Investigator
Colorado
SMC-Trauma Research, Englewood, Colorado, 80113, United States; Recruiting
Eli Landry 303-788-4051 elilandry@aol.com
Lawrence Kim, MD, Principal Investigator
Lawrence Kim, MD, Principal Investigator
Florida
Borland-Groover Clinic, Jacksonville, Florida, 32256, United States; Recruiting
Linda Burton 904-680-0871 lburton@BGClinic.com
Lawrence Goldberg, MD, Principal Investigator
Lawrence Goldberg, MD, Principal Investigator
Shafran Gastroenterology Center, Winter Park, Florida, 32789, United States; Recruiting
Johnathan Decker 407-629-8121 nursej1@msn.com
Ira Shafran, MD, Principal Investigator
Ira Shafran, MD, Principal Investigator
V.A. Medical Center, Gainesville, Florida, 32608, United States; Recruiting
Theresa Huber 352-376-1611 Ext. x6942 Theresa.Huber2@med.va.gov
John Valentine, MD, Principal Investigator
John Valentine, MD, Principal Investigator
Clinical Research of West Florida, Inc, Clearwater, Florida, 33765, United States; Recruiting
Pamela Darley 727-466-0078 Ext. x226 pdarley@crwfinc.com
Michael Weiss, MD, Principal Investigator
Michael Weiss, MD, Principal Investigator
Georgia
Pinnacle Trials, Inc., Atlanta, Georgia, 30329, United States; Terminated
Atlanta Gastroenterology Assoc., Atlanta, Georgia, 30342, United States; Not yet recruiting
Meredith Mourm 404-257-9000 m4desk@aol.com
Douglas C. Wolf, MD, Principal Investigator
Douglas C. Wolf, MD, Principal Investigator
Illinois
Ntouch Research, Peoria, Illinois, 60602, United States; Recruiting
Sharon Thompson 309-672-1910 Ext. x 122 sthompson@ntouchresearch.com
Ben Dolin, MD, Principal Investigator
Ben Dolin, MD, Principal Investigator
The University of Chicago, Chicago, Illinois, 60673, United States; Recruiting
Heather Brenner 773-702-1466 Hbrenner@medicine.bsd.uchicago.edu
Stephen B Hanauer, MD, Principal Investigator
Stephen B Hanauer, MD, Principal Investigator
Indiana
Outpatient Clinical Research Facility University of Indianapolis, Indianapolis, Indiana, 462025250, United States; Not yet recruiting
Marta Sears 317-274-3974 msears@iupui.edu
Debra J Helper, MD, Principal Investigator
Debra J Helper, MD, Principal Investigator
Kentucky
University of Kentucky Medical Center Division of Digestive Diseases, Lexington, Kentucky, 40536, United States; Recruiting
Jeri Reynolds 859-323-6423 jeri.reynolds@uky.edu
Willem de Villiers, MD, Principal Investigator
Willem de Villiers, MD, Principal Investigator
Louisiana
Drug Research Services, Inc., Metairie, Louisiana, 70001, United States; Recruiting
Catina Gordon-Oates 504-456-1433 catina@drsinc.net
David R Silvers, MD, Principal Investigator
David R Silvers, MD, Principal Investigator
Maryland
Chevy Chase Clinical Research, Chevy Chase, Maryland, 20815, United States; Recruiting
Susanna Milton 301-652-5520 robidoc@aol.com
Robert Hardi, MD, Principal Investigator
Robert Hardi, MD, Principal Investigator
Charm City Research, Towson, Maryland, 21204, United States; Recruiting
Janet Heidrick 410-825-4200 jheidrick@charmcity.com
James Novick, MD, Principal Investigator
James Novick, MD, Principal Investigator
Minnesota
Mayo Clinic Research, Rochester, Minnesota, 559050002, United States; Recruiting
Resa Jeche 507-284-2511 jeche.resa@mayo.edu
William Sandborn, MD, Principal Investigator
William Sandborn, MD, Principal Investigator
Minnesota Gastroenterology P.A., Plymouth, Minnesota, 55446, United States; Not yet recruiting
Karah Neisen 612-870-5594 KNeisen@mngastro.com
Robert McCabe, MD, Principal Investigator
Robert McCabe, MD, Principal Investigator
Mississippi
Gastrointestinal Associated, P.A., Jackson, Mississippi, 39202, United States; Recruiting
Donna Darwin 601-683-0395 ddarwin@sumres.com
Billy Long, MD, Principal Investigator
Billy Long, MD, Principal Investigator
Missouri
St. Louis Center for Clinical Research, St. Louis, Missouri, 63128, United States; Recruiting
Melissa Donlon 314-543-5225 investigators@slccr.com
James Dimitroff, MD, Principal Investigator
James Dimitroff, MD, Principal Investigator
Glen Gordon, MD, Mexico, Missouri, 65265, United States; Recruiting
Brenda Gordon 573-581-7196 brenda@gutdoc.net
Glenn Gordon, MD, Principal Investigator
Glenn Gordon, MD, Principal Investigator
New Jersey
Atlantic Gastroenterology Associates, LLC, Egg Harbor Township, New Jersey, 08234, United States; Recruiting
Theresa Stevens 609-407-1220
Barry Kaufman, MD, Principal Investigator
Barry Kaufman, MD, Principal Investigator
New York
NY Center for Clinical Research, Lake Success, New York, 11042, United States; Recruiting
Melissa Erdvig 516-326-2700 merdvig@aol.com
David Eskreis, MD, Principal Investigator
David Eskreis, MD, Principal Investigator
Long Island Clinical Research Assoc. LLP, Great Neck, New York, 11021, United States; Not yet recruiting
Andy Mulchinski 516-466-1051 Amulchinski@liclinical.com
Seymour Katz, MD, Principal Investigator
Seymour Katz, MD, Principal Investigator
North Carolina
Wake Research Associates, Raleigh, North Carolina, 27612, United States; Recruiting
Marsha Peery 919-781-2514 mpeery@wakeresearch.com
Charles Barish, MD, Principal Investigator
Charles Barish, MD, Principal Investigator
Asheville Gastroenterology Associates, Ashville, North Carolina, 28801, United States; Recruiting
Geoffrey Kitchingman 828-254-0881 Ext. x 388 Geoffrey.Kitchingman@ashevillegastro.com
William R Harlan, MD, Principal Investigator
William R Harlan, MD, Principal Investigator
Ohio
Gastroenterology Associates of Cleveland, Mayfield Heights, Ohio, 44124, United States; Recruiting
Sue Davies 440-442-6173 research@gastro-associates.com
Dianne Himmelman 440-442-6173 research@gastro-associates.com
Michael Frankel, MD, Principal Investigator
Dianne Himmelman 440-442-6173 research@gastro-associates.com
Michael Frankel, MD, Principal Investigator
Gastrointestinal and Liver Disease Consultants, Dayton, Ohio, 45440, United States; Recruiting
Mary Harvey 937-307-9931 targetrsch@aol.com
Donald Lutter, MD, Principal Investigator
Donald Lutter, MD, Principal Investigator
Consultants for Clinical Research, Cincinnati, Ohio, 45219, United States; Not yet recruiting
Linda Magaw 513-872-4549 gcombs@ccrstudy.com
Alan V Safdi, MD, Principal Investigator
Alan V Safdi, MD, Principal Investigator
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Not yet recruiting
Amy Knesebeck, RN 216-444-6524 lashneb@ccf.org
Bret Lashner, MD, Principal Investigator
Bret Lashner, MD, Principal Investigator
Oregon
The Oregon Clinic, PC Gastroenterology Division, Portland, Oregon, 97220, United States; Recruiting
Tim Miller, BS, CRC 503-963-2756 tmiller@orclinic.com
Phillip K Kiyasu, Md, Principal Investigator
Phillip K Kiyasu, Md, Principal Investigator
Pennsylvania
Regional Gastroenterologist Associates of Lancaster, Lancaster, Pennsylvania, 17604, United States; Terminated
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15261, United States; Recruiting
Kimberly Jones 412-648-9083 jonesk@msx.dept-med.pitt.edu
Miguel Regueiro, MD, Principal Investigator
Miguel Regueiro, MD, Principal Investigator
South Carolina
Columbia Gastro Associates, Columbia, South Carolina, 29204, United States; Recruiting
Sandy Boone, MD 803-419-2120 sfboone@bellsouth.net
John Popp, MD, Principal Investigator
John Popp, MD, Principal Investigator
Tennessee
Gastrointestinal Associates, Knoxville, Tennessee, 37909, United States; Recruiting
Jan Miller 865-583-1286
John Haydek, MD, Principal Investigator
John Haydek, MD, Principal Investigator
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States; Not yet recruiting
Karen Bargatze 615-322-8398 karen.bargatze@vanderbilt.edu
David Schwartz, MD, Principal Investigator
David Schwartz, MD, Principal Investigator
Gastroenterology Center of the Mid South, Memphis, Tennessee, 38120, United States; Recruiting
Jim Marchand 901-820-0090 jamesm@gicentermidsouth.com
Zaid Younes, MD, Principal Investigator
Zaid Younes, MD, Principal Investigator
Texas
Austin Gastroenterology, Austin, Texas, 78745, United States; Recruiting
Linda Salas 512-532-8028 lindas@austingastro.com
William Stassen, MD, Principal Investigator
William Stassen, MD, Principal Investigator
Utah
Wasatch Clinical Research, Salt Lake City, Utah, 84107, United States; Not yet recruiting
Karen George 801-288-0607 kgeorge@wasatchcrc.com
P J. Pederson, M.D., Principal Investigator
P J. Pederson, M.D., Principal Investigator
Virginia
Digestive and Liver Disease, Norfolk, Virginia, 23205, United States; Recruiting
Becky Mosconi 757-466-0165 beckym@dlds.org
Internal Medicine Associates, Danville, Virginia, 25451, United States; Recruiting
Trisha Jones 434-792-2339 Ext. x 118 imadanville@aol.com
Jack Bryan Spainhour, MD, Principal Investigator
Jack Bryan Spainhour, MD, Principal Investigator
Washington
Spokane Digestive Disease Center, Spokane, Washington, 99204, United States; Recruiting
Jeannell Love, CCRC 509-232-4265 jlove@sddcdocs.com
Karl Houglum, MD, Principal Investigator
Karl Houglum, MD, Principal Investigator
Wisconsin
Discovery Research International, LLC, Milwaukee, Wisconsin, 53207, United States; Recruiting
Kathy Otto 414-385-8680 dri@dozerresearch.com
David Dozer, MD, Principal Investigator
David Dozer, MD, Principal Investigator
More Information
Study ID Numbers: M04-691
Record last reviewed: March 2005
Last Updated: March 29, 2005
Record first received: March 11, 2005
ClinicalTrials.gov Identifier: NCT00105300
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: March 29, 2005
Record first received: March 11, 2005
ClinicalTrials.gov Identifier: NCT00105300
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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