Back to resultsEfficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
Primary Purpose
Crohn Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sargramostim (Leukine)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Morbus Crohn, Sargramostim, Phase III, Placebo Controlled
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Induction of clinical response and/or remission as defined by decrease in CDAI score
Secondary Outcome Measures
Time and duration to response/remission
QoL (different methods)
Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
Full Information
NCT ID
NCT00206674
First Posted
September 13, 2005
Last Updated
December 2, 2013
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00206674
Brief Title
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Morbus Crohn, Sargramostim, Phase III, Placebo Controlled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sargramostim (Leukine)
Other Intervention Name(s)
BAY86-5326
Intervention Description
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
Primary Outcome Measure Information:
Title
Induction of clinical response and/or remission as defined by decrease in CDAI score
Time Frame
After 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Time and duration to response/remission
Time Frame
During the 8 weeks of treatment
Title
QoL (different methods)
Time Frame
During the whole study
Title
Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
Time Frame
About 20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
C1118AAT
Country
Argentina
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
C1264AAA
Country
Argentina
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5043
Country
Australia
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
City
Penrith
ZIP/Postal Code
2751
Country
Australia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110060
Country
Brazil
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060-900
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21949 900
Country
Brazil
City
Porto Alegre
State/Province
RS
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
05651-901
Country
Brazil
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6T9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1L9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E9
Country
Canada
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
City
Milford
State/Province
Auckland
ZIP/Postal Code
1309
Country
New Zealand
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
City
Lipetsk
State/Province
Russia
ZIP/Postal Code
398055
Country
Russian Federation
City
Moskva
State/Province
Russia
ZIP/Postal Code
105203
Country
Russian Federation
City
Samara
State/Province
Russia
ZIP/Postal Code
443023
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123154
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
Moskva
ZIP/Postal Code
127015
Country
Russian Federation
City
Volgograd
ZIP/Postal Code
400107
Country
Russian Federation
City
Lausanne
State/Province
Waadt
ZIP/Postal Code
1011
Country
Switzerland
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Donetsk
ZIP/Postal Code
83017
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61001
Country
Ukraine
City
Kiev
ZIP/Postal Code
03049
Country
Ukraine
City
Lviv
ZIP/Postal Code
49044
Country
Ukraine
City
Vinnitsa
ZIP/Postal Code
26014
Country
Ukraine
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
City
London
State/Province
Greater London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
City
Newcastle Upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
City
London
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
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