Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
NCT ID: NCT00206674
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
286 participants
INTERVENTIONAL
2004-09-30
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Sargramostim (Leukine)
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
Arm 2
Placebo
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
Interventions
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Sargramostim (Leukine)
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
Placebo
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to self-inject or have another person who can help with the injection
Exclusion Criteria
* Not be taking prohibited medications as defined in the protocol
* Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months
* Not have ever taken this drug or drugs of similar type in the past
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Garran, Australian Capital Territory, Australia
Concord, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Brisbane, Queensland, Australia
Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
Launceston, Tasmania, Australia
Ballarat, Victoria, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Prahran, Victoria, Australia
Fremantle, Western Australia, Australia
Penrith, , Australia
Salvador, Estado de Bahia, Brazil
Curitiba, Paraná, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Milford, Auckland, New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
Lipetsk, Russia, Russia
Moskva, Russia, Russia
Samara, Russia, Russia
Moscow, , Russia
Moscow, , Russia
Moskva, , Russia
Volgograd, , Russia
Basel, Basel, Switzerland
Bern, Canton of Bern, Switzerland
Lausanne, Canton of Vaud, Switzerland
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Vinnitsa, , Ukraine
Bristol, Avon, United Kingdom
London, Greater London, United Kingdom
Salford, Greater Manchester, United Kingdom
Edinburgh, Lothian, United Kingdom
Liverpool, Merseyside, United Kingdom
Harrow, Middlesex, United Kingdom
Cardiff, South Glamorgan, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
London, , United Kingdom
Sheffield, , United Kingdom
Countries
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Other Identifiers
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91405
Identifier Type: -
Identifier Source: secondary_id
Novel 4
Identifier Type: -
Identifier Source: secondary_id
308380
Identifier Type: -
Identifier Source: org_study_id
NCT00185497
Identifier Type: -
Identifier Source: nct_alias