Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00206674




Registration number
NCT00206674
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
4/12/2013

Titles & IDs
Public title
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
Scientific title
Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease
Secondary ID [1] 0 0
91405
Secondary ID [2] 0 0
308380
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sargramostim (Leukine)
Treatment: Drugs - Placebo

Experimental: Arm 1 -

Placebo Comparator: Arm 2 -


Treatment: Drugs: Sargramostim (Leukine)
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks

Treatment: Drugs: Placebo
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction of clinical response and/or remission as defined by decrease in CDAI score
Timepoint [1] 0 0
After 8 weeks of treatment
Secondary outcome [1] 0 0
Time and duration to response/remission
Timepoint [1] 0 0
During the 8 weeks of treatment
Secondary outcome [2] 0 0
QoL (different methods)
Timepoint [2] 0 0
During the whole study
Secondary outcome [3] 0 0
Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
Timepoint [3] 0 0
About 20 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2006
Sample size
Target
Accrual to date
Final
286
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Concord
Recruitment hospital [3] 0 0
- New Lambton Heights
Recruitment hospital [4] 0 0
- Sydney
Recruitment hospital [5] 0 0
- Brisbane
Recruitment hospital [6] 0 0
- Adelaide
Recruitment hospital [7] 0 0
- Launceston
Recruitment hospital [8] 0 0
- Ballarat
Recruitment hospital [9] 0 0
- Frankston
Recruitment hospital [10] 0 0
- Melbourne
Recruitment hospital [11] 0 0
- Parkville
Recruitment hospital [12] 0 0
- Prahran
Recruitment hospital [13] 0 0
- Fremantle
Recruitment hospital [14] 0 0
- Penrith
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
2050 - Sydney
Recruitment postcode(s) [5] 0 0
2200 - Sydney
Recruitment postcode(s) [6] 0 0
4029 - Brisbane
Recruitment postcode(s) [7] 0 0
4101 - Brisbane
Recruitment postcode(s) [8] 0 0
5043 - Adelaide
Recruitment postcode(s) [9] 0 0
7250 - Launceston
Recruitment postcode(s) [10] 0 0
3350 - Ballarat
Recruitment postcode(s) [11] 0 0
3199 - Frankston
Recruitment postcode(s) [12] 0 0
3065 - Melbourne
Recruitment postcode(s) [13] 0 0
3128 - Melbourne
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
3181 - Prahran
Recruitment postcode(s) [16] 0 0
6160 - Fremantle
Recruitment postcode(s) [17] 0 0
2751 - Penrith
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Capital Federal
Country [2] 0 0
Brazil
State/province [2] 0 0
Bahia
Country [3] 0 0
Brazil
State/province [3] 0 0
Parana
Country [4] 0 0
Brazil
State/province [4] 0 0
RJ
Country [5] 0 0
Brazil
State/province [5] 0 0
RS
Country [6] 0 0
Brazil
State/province [6] 0 0
SP
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Manitoba
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Christchurch
Country [14] 0 0
New Zealand
State/province [14] 0 0
Hamilton
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Russia
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Moscow
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Moskva
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Volgograd
Country [19] 0 0
Switzerland
State/province [19] 0 0
Waadt
Country [20] 0 0
Switzerland
State/province [20] 0 0
Basel
Country [21] 0 0
Switzerland
State/province [21] 0 0
Bern
Country [22] 0 0
Ukraine
State/province [22] 0 0
Donetsk
Country [23] 0 0
Ukraine
State/province [23] 0 0
Kharkiv
Country [24] 0 0
Ukraine
State/province [24] 0 0
Kiev
Country [25] 0 0
Ukraine
State/province [25] 0 0
Lviv
Country [26] 0 0
Ukraine
State/province [26] 0 0
Vinnitsa
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Avon
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Greater London
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Greater Manchester
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Lothian
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Merseyside
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Middlesex
Country [33] 0 0
United Kingdom
State/province [33] 0 0
South Glamorgan
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Tyne and Wear
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate if Leukine can induce clinical response or remission
in patients with Crohn's disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00206674
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Genzyme, a Sanofi Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00206674