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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00295321




Registration number
NCT00295321
Ethics application status
Date submitted
21/02/2006
Date registered
23/02/2006
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
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease
Secondary ID [1] 0 0
91494
Secondary ID [2] 0 0
310187
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
1. Written informed consent
2. Male or female, age >/= 18 years
3. Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
4. Moderately to severely active Crohn's disease at time of screening (i.e., CDAI greater than or equal to 220 and less than or equal to 475 points)
5. If under treatment for Crohn's disease, medication must be stable for at least 4 weeks prior to receiving the first dose of study drug. The following therapies are allowed:

* Oral therapy with salicylates (mesalamine, sulfasalazine, olsalazine, or balsalazide) for Crohn's disease
* Antibiotics or probiotics for Crohn's disease
* Topical rectal therapy with mesalamine
6. Females of child-bearing potential:

Negative pregnancy test within 72 hours prior to receiving the first dose of study drug
7. Sexually-active males and females of child-bearing potential:

Agreement to use adequate method of contraception throughout the study
8. Ability to self-inject study drug or availability of a designee who can do so
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or breast-feeding
2. Colostomy or ileostomy
3. Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
4. GI surgery within 6 months prior to receiving the first dose of study drug
5. Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
6. Positive stool test results for any of the following:

Bacteria:
* Salmonella spec.
* Shigella spec.
* Campylobacter spec.

Bacterial toxin:
* Clostridium difficile

Ova and parasites:
* Amoeba spec.
* Giardia spec.
* Cryptosporidium spec.
7. Any of the following laboratory abnormalities:

* Serum creatinine >/= 2.0 mg/dL
* Alkaline phosphatase (AP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >/=; 2 x the upper limit of normal
* Hemoglobin (Hgb) < 8.0 g/dL
* Absolute neutrophil count (ANC) </= 1,000 cells/µL or > cells 20,000/µL
8. Planned in-patient hospitalization during the study
9. Presence or history of cancer of any type (except treated basal cell carcinoma) or definite dysplasia of the colon within the last 5 years
10. Use of any of the following medications during the specified period of time prior to receiving the first dose of study drug:

At any time:
* Recombinant human GM CSF (sargramostim or molgramostim)
* Granulocyte colony-stimulating factor (G CSF; filgrastim or pegfilgrastim)
* Natalizumab 8 weeks: or 5 half-lives (whichever is longer)
* Licensed/registered and/or experimental anti-tumor necrosis factor (TNF) therapy such as infliximab or adalimumab 4 weeks:
* 6-mercaptopurine
* Azathioprine
* Cyclophosphamide
* Methotrexate
* Mycophenolate mofetil
* Tacrolimus
* Cyclosporine
* Thalidomide
* Glucocorticoids, including budesonide and prednisone, or local glucocorticoid therapy for Crohn's disease
* Any other immunosuppressive drugs
11. Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug
12. Use of nutritional therapy (parenteral nutrition or enteral nutrition with elemental or semi-elemental diets) within 4 weeks prior to receiving the first dose of study drug. If the physician judges that nutritional supplementation is needed, enteral nutritional supplements will be allowed for patients who have been receiving a stable regimen for at least 4 weeks prior to receiving the first dose of study drug and that is intended to continue through the 8 week treatment period.
13. History of allergy to yeast products or to sargramostim or to any other excipient of the study drug formulation
14. Active drug or alcohol abuse
15. Clinically important co-morbid conditions unrelated to Crohn's disease as determined by the investigator
16. Previous randomization into this study, or into any other study of the sponsor's sargramostim development program

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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2006
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)

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/study/NCT00295321
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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/study/NCT00295321