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A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease


Phase 3
18 Years
75 Years
Not Enrolling
Both
Crohn's Disease

Thank you

Trial Information

A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease


Inclusion Criteria:



- Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691
(NCT00105300) protocol to be eligible for this study

- Diagnosis of Crohn's disease

- Willing and able to give informed consent

Exclusion Criteria:

- Diagnosis of ulcerative colitis

- Women cannot be pregnant or breastfeeding

- Previous history of listeria infection or untreated tuberculosis

- Previous history of cancer other than successfully treated skin cancer or
carcinoma-in-situ of the cervix

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Subjects Achieving Clinical Remission

Outcome Description:

Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

Outcome Time Frame:

Week 156

Safety Issue:

No

Principal Investigator

Anne Camez, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M04-690

NCT ID:

NCT00195715

Start Date:

September 2004

Completion Date:

December 2008

Related Keywords:

  • Crohn's Disease
  • Crohn Disease

Name

Location

Site Ref # / Investigator 1894Huntsville, Alabama  35801
Site Ref # / Investigator 1895Jacksonville, Alabama  35801
Site Ref # / Investigator 1787La Jolla, California  92037
Site Ref # / Investigator 1902Roseville, California  95661
Site Ref # / Investigator 1891San Diego, California  92123
Site Ref # / Investigator 1824San Diego, California  92123
Site Ref # / Investigator 1860Englewood, Colorado  80113
Site Ref # / Investigator 6178Lone Tree, Colorado  80124
Site Ref # / Investigator 1904Wheat Ridge, Colorado  80033
Site Ref # / Investigator 1858Bridgeport, Connecticut  06606
Site Ref # / Investigator 1827Clearwater, Florida  33765
Site Ref # / Investigator 1883Gainesville, Florida  32610
Site Ref # / Investigator 1909Hollywood, Florida  33021
Site Ref # / Investigator 1884Ormond Beach, Florida  32174
Site Ref # / Investigator 1786Winter Park, Florida  32789
Site Ref # / Investigator 1912Atlanta, Georgia  30342
Site Ref # / Investigator 1878Arlington Heights, Illinois  60005
Site Ref # / Investigator 2534Chicago, Illinois  60637
Site Ref # / Investigator 1823Peoria, Illinois  61602
Site Ref # / Investigator 1885Anderson, Indiana  46016
Site Ref # / Investigator 1890Indianapolis, Indiana  46237
Site Ref # / Investigator 1900Indianapolis, Indiana  46202
Site Ref # / Investigator 1892Lexington, Kentucky  40536
Site Ref # / Investigator 1906Metairie, Louisiana  70006
Site Ref # / Investigator 1881Annapolis, Maryland  24101
Site Ref # / Investigator 1829Chevy Chase, Maryland  20815
Site Ref # / Investigator 1782Lutherville, Maryland  21093
Site Ref # / Investigator 1887Silver Spring, Maryland  20901
Site Ref # / Investigator 2602Worcester, Massachusetts  01610
Site Ref # / Investigator 1773Plymouth, Minnesota  55446
Site Ref # / Investigator 1856Rochester, Minnesota  55905
Site Ref # / Investigator 1832Jackson, Mississippi  39202
Site Ref # / Investigator 1880Kansas City, Missouri  64131
Site Ref # / Investigator 1853Mexico, Missouri  65265
Site Ref # / Investigator 1862St. Louis, Missouri  63128
Site Ref # / Investigator 1888St. Louis, Missouri  63110
Site Ref # / Investigator 1901Egg Harbor Township, New Jersey  08234
Site Ref # / Investigator 1825Great Neck, New York  11021
Site Ref # / Investigator 1848Lake Success, New York  11042
Site Ref # / Investigator 1841New York, New York  10028
Site Ref # / Investigator 1852Asheville, North Carolina  28801
Site Ref # / Investigator 1882Charlote, North Carolina  28211
Site Ref # / Investigator 1855Charlotte, North Carolina  28207
Site Ref # / Investigator 1911Raleigh, North Carolina  27612
Site Ref # / Investigator 1861Wilmington, North Carolina  28403
Site Ref # / Investigator 1784Beachwood, Ohio  44122
Site Ref # / Investigator 1896Beaver Creek, Ohio  45440
Site Ref # / Investigator 1833Cincinatti, Ohio  45219
Site Ref # / Investigator 1826Cleveland, Ohio  44106-5066
Site Ref # / Investigator 1822Portland, Oregon  97220
Site Ref # / Investigator 1886Pittsburgh, Pennsylvania  15216
Site Ref # / Investigator 1905Columbia, South Carolina  29204
Site Ref # / Investigator 1769Germantown, Tennessee  38138
Site Ref # / Investigator 1907Nashville, Tennessee  37205
Site Ref # / Investigator 1963Nashville, Tennessee  37232
Site Ref # / Investigator 1899Round Rock, Texas  78681
Site Ref # / Investigator 1903Salt Lake City, Utah  84107
Site Ref # / Investigator 6180Charlottesville, Virginia  22911
Site Ref # / Investigator 1783Danville, Virginia  24541
Site Ref # / Investigator 1897Norfolk, Virginia  23502
Site Ref # / Investigator 1850Spokane, Washington  99204
Site Ref # / Investigator 1831Milwaukee, Wisconsin  53215
Site Ref # / Investigator 1849West Bend, Wisconsin  53095