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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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
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4029 - Brisbane
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4101 - Brisbane
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5043 - Adelaide
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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
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United States of America
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Alabama
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Arizona
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California
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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New Hampshire
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New Jersey
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New York
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Argentina
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Bahia
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New Zealand
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Auckland
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Christchurch
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New Zealand
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Hamilton
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Russian Federation
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Russia
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Moscow
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Lviv
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Vinnitsa
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Lothian
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Merseyside
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Middlesex
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South Glamorgan
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Tyne and Wear
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London
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United Kingdom
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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 establish a safety profile sargramostim administered in 8
week cycles to adult patients with active Crohn's disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00206700
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/NCT00206700