Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Abbott
Study ID
NCT00195715
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab 40 mg by subcutaneous injection every other week or every week

Study Details

To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

Key Dates

Start date
Sep 30, 2004
Status verified
Jul 2011
Primary completion
Mar 31, 2006
Completion
Dec 31, 2008

Study Design

Enrollment
777 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Percentage of Subjects Achieving Clinical Remission [ Time Frame: Week 156 ]

Locations (63)

FacilityCityStateZIPSite coordinators
Site Ref # / Investigator 1894HuntsvilleAlabama35801-
Site Ref # / Investigator 1895JacksonvilleAlabama35801-
Site Ref # / Investigator 1787La JollaCalifornia92037-
Site Ref # / Investigator 1902RosevilleCalifornia95661-
Site Ref # / Investigator 1824San DiegoCalifornia92123-
Site Ref # / Investigator 1891San DiegoCalifornia92123-
Site Ref # / Investigator 1860EnglewoodColorado80113-
Site Ref # / Investigator 6178Lone TreeColorado80124-
Site Ref # / Investigator 1904Wheat RidgeColorado80033-
Site Ref # / Investigator 1858BridgeportConnecticut06606-
Site Ref # / Investigator 1827ClearwaterFlorida33765-
Site Ref # / Investigator 1883GainesvilleFlorida32610-
Site Ref # / Investigator 1909HollywoodFlorida33021-
Site Ref # / Investigator 1884Ormond BeachFlorida32174-
Site Ref # / Investigator 1786Winter ParkFlorida32789-
Site Ref # / Investigator 1912AtlantaGeorgia30342-
Site Ref # / Investigator 1878Arlington HeightsIllinois60005-
Site Ref # / Investigator 2534ChicagoIllinois60637-
Site Ref # / Investigator 1823PeoriaIllinois61602-
Site Ref # / Investigator 1885AndersonIndiana46016-
Site Ref # / Investigator 1890IndianapolisIndiana46237-
Site Ref # / Investigator 1900IndianapolisIndiana46202-
Site Ref # / Investigator 1892LexingtonKentucky40536-
Site Ref # / Investigator 1906MetairieLouisiana70006-
Site Ref # / Investigator 1881AnnapolisMaryland24101-
Site Ref # / Investigator 1829Chevy ChaseMaryland20815-
Site Ref # / Investigator 1782LuthervilleMaryland21093-
Site Ref # / Investigator 1887Silver SpringMaryland20901-
Site Ref # / Investigator 2602WorcesterMassachusetts01610-
Site Ref # / Investigator 1773PlymouthMinnesota55446-
Site Ref # / Investigator 1856RochesterMinnesota55905-
Site Ref # / Investigator 1832JacksonMississippi39202-
Site Ref # / Investigator 1880Kansas CityMissouri64131-
Site Ref # / Investigator 1853MexicoMissouri65265-
Site Ref # / Investigator 1862St LouisMissouri63128-
Site Ref # / Investigator 1888St LouisMissouri63110-
Site Ref # / Investigator 1901Egg HarborNew Jersey08234-
Site Ref # / Investigator 1825Great NeckNew York11021-
Site Ref # / Investigator 1848Lake SuccessNew York11042-
Site Ref # / Investigator 1841New YorkNew York10028-
Site Ref # / Investigator 1852AshevilleNorth Carolina28801-
Site Ref # / Investigator 1882CharloteNorth Carolina28211-
Site Ref # / Investigator 1855CharlotteNorth Carolina28207-
Site Ref # / Investigator 1911RaleighNorth Carolina27612-
Site Ref # / Investigator 1861WilmingtonNorth Carolina28403-
Site Ref # / Investigator 1784BeachwoodOhio44122-
Site Ref # / Investigator 1896BeavercreekOhio45440-
Site Ref # / Investigator 1833CincinnatiOhio45219-
Site Ref # / Investigator 1826ClevelandOhio44106-5066-
Site Ref # / Investigator 1822PortlandOregon97220-
Site Ref # / Investigator 1886PittsburghPennsylvania15216-
Site Ref # / Investigator 1905ColumbiaSouth Carolina29204-
Site Ref # / Investigator 1769GermantownTennessee38138-
Site Ref # / Investigator 1907NashvilleTennessee37205-
Site Ref # / Investigator 1963NashvilleTennessee37232-
Site Ref # / Investigator 1899Round RockTexas78681-
Site Ref # / Investigator 1903Salt Lake CityUtah84107-
Site Ref # / Investigator 6180CharlottesvilleVirginia22911-
Site Ref # / Investigator 1783DanvilleVirginia24541-
Site Ref # / Investigator 1897NorfolkVirginia23502-
Site Ref # / Investigator 1850SpokaneWashington99204-
Site Ref # / Investigator 1831MilwaukeeWisconsin53215-
Site Ref # / Investigator 1849West BendWisconsin53095-

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