Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00206700




Registration number
NCT00206700
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
4/12/2013

Titles & IDs
Public title
Open-label Trial of Leukine in Active Crohn's Disease
Scientific title
Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease
Secondary ID [1] 0 0
91274
Secondary ID [2] 0 0
307340
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)

Experimental: Arm 1 -


Treatment: Drugs: Sargramostim (Leukine)
Open Label, 8 week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease.
Timepoint [1] 0 0
Not applicable for this outcome
Secondary outcome [1] 0 0
Crohn's disease activity
Timepoint [1] 0 0
After successive 8-week cycles of treatment
Secondary outcome [2] 0 0
Duration of clinical remission and time to disease flare
Timepoint [2] 0 0
After successive cycles of sargramostim therapy
Secondary outcome [3] 0 0
Patient compliance
Timepoint [3] 0 0
After successive cycles of sargramostim therapy

Eligibility
Key inclusion criteria
* Able to provide informed consent
* Participated in a previous study of sargramostim in Crohn's disease within the past 12 months
* Subjects who participated in protocols excluding concomitant steroid use:
* Must have moderately to severely active Crohn's disease at time of screening (CDAI score >/= 220 points and less than or equal to 475 points)
* Must be receiving less than or equal to 40 mg prednisone (or equivalent) daily at time of screening if treated with corticosteroids between completing their previous sargramostim study and entry into this study and be able to taper to less than or equal to 7.5 mg daily within one treatment cycle
* Subjects who participated in Protocol 307501
* Must have active Crohn's disease (CDAI score > 150 points and less than or equal to 450 points) if completely withdrawn from CS use
* Must be receiving less than or equal to 40 mg prednisone (or equivalent) daily at time of screening, be able to taper to less than or equal to 7.5 mg daily within 2 treatment cycles, and have a CDAI score less than or equal to 450 points if not completely withdrawn from CS use
* Have a negative serum pregnancy test within 2 weeks prior to receiving initial dose of sargramostim in female subjects of child-bearing potential (optional - may be waived by the investigator if the subject has had no interruption in contraception method since participation in the previous study)
* Agree to use of an adequate method of contraception throughout the study period for sexually-active males and females of childbearing potential
* Able to self-inject sargramostim or have a designee who can do so
* Able to comply with protocol requirements
* Have a negative stool exam if subject received a course of antibiotics since participation in the previous study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding female
* Need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
* Gastrointestinal surgery within the prior 6 months
* Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
* Serum creatinine greater than or equal to 2.0 mg/dL
* Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin greater or equal to 2X the upper limit of normal; hemoglobin (Hb) < 8.0 gm/dL; platelet count greater than or equal to 800,000/mL; ANC less than or equal to 1,000/µL or > 20,000/µL (the exclusion of subjects with ANC > 20,000/µL applies only to entry into the first treatment cycle)
* Use of licensed/registered anti-tumor necrosis factor (TNF) therapy such as infliximab within 8 weeks prior to first dose of study drug in this trial
* Use of any of the following medications within 4 weeks prior to receiving the first dose of study drug: 6-mercaptopurine, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, or thalidomide
* Use of any experimental agent in a clinical trial since participating in a sargramostim trial
* History of allergy to yeast products or sargramostim
* Psychiatric illness or substance abuse that would interfere with ability to comply with protocol requirements or give informed consent
* Clinically important primary disease unrelated to Crohn's disease
* Prior exposure to natalizumab (Tysabri)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2006
Sample size
Target
Accrual to date
Final
378
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
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
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United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
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Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Montana
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New Hampshire
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
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Oklahoma
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United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Argentina
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Capital Federal
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Brazil
State/province [35] 0 0
Bahia
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Brazil
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Parana
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SP
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Manitoba
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
New Zealand
State/province [45] 0 0
Auckland
Country [46] 0 0
New Zealand
State/province [46] 0 0
Christchurch
Country [47] 0 0
New Zealand
State/province [47] 0 0
Hamilton
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Russia
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Moskva
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Russian Federation
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Volgograd
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Switzerland
State/province [52] 0 0
Waadt
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Switzerland
State/province [53] 0 0
Basel
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Switzerland
State/province [54] 0 0
Bern
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Ukraine
State/province [55] 0 0
Donetsk
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Ukraine
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Kharkiv
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Ukraine
State/province [57] 0 0
Kiev
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Ukraine
State/province [58] 0 0
Lviv
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Ukraine
State/province [59] 0 0
Vinnitsa
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Avon
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Greater London
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Greater Manchester
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Lothian
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Merseyside
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Middlesex
Country [66] 0 0
United Kingdom
State/province [66] 0 0
South Glamorgan
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Tyne and Wear
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London
Country [69] 0 0
United Kingdom
State/province [69] 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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00206700