Clinical trial NCT00206674: Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
Official title: Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Morbus Crohn
Sargramostim
Phase III
Placebo Controlled
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

Detailed description: On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility criteria: Inclusion Criteria:

* Stable but active Crohn's disease at the time of screening
* Must be able to self-inject or have another person who can help with the injection

Exclusion Criteria:

* Not have a colostomy or ileostomy
* 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

Primary outcomes:
measure: Induction of clinical response and/or remission as defined by decrease in CDAI score
timeFrame: After 8 weeks of treatment
Secondary outcomes:
measure: Time and duration to response/remission
timeFrame: During the 8 weeks of treatment
measure: QoL (different methods)
timeFrame: During the whole study
measure: Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
timeFrame: About 20 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Garran
country: Australia
state: Australian Capital Territory
city: Concord
country: Australia
state: New South Wales
city: New Lambton Heights
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Brisbane
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Launceston
country: Australia
state: Tasmania
city: Ballarat
country: Australia
state: Victoria
city: Frankston
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Prahran
country: Australia
state: Victoria
city: Fremantle
country: Australia
state: Western Australia
city: Penrith
country: Australia
city: Salvador
country: Brazil
state: Bahia
city: Curitiba
country: Brazil
state: Parana
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Sao Paulo
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Milford
country: New Zealand
state: Auckland
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
city: Lipetsk
country: Russian Federation
state: Russia
city: Moskva
country: Russian Federation
state: Russia
city: Samara
country: Russian Federation
state: Russia
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moskva
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Lausanne
country: Switzerland
state: Waadt
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Bristol
country: United Kingdom
state: Avon
city: London
country: United Kingdom
state: Greater London
city: Salford
country: United Kingdom
state: Greater Manchester
city: Edinburgh
country: United Kingdom
state: Lothian
city: Liverpool
country: United Kingdom
state: Merseyside
city: Harrow
country: United Kingdom
state: Middlesex
city: Cardiff
country: United Kingdom
state: South Glamorgan
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne and Wear
city: London
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: