Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
NCT ID: NCT00295165
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
33 participants
INTERVENTIONAL
2006-01-31
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Sargramostim (Leukine)
Sargramostim 6 mcg/kg subcutaneously once daily
Arm 2
Placebo
Placebo subcutaneously once daily
Interventions
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Sargramostim (Leukine)
Sargramostim 6 mcg/kg subcutaneously once daily
Placebo
Placebo subcutaneously once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Huntsville, Alabama, United States
Orange, California, United States
San Francisco, California, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Hagerstown, Maryland, United States
Lutherville, Maryland, United States
Towson, Maryland, United States
Ann Arbor, Michigan, United States
Chesterfield, Michigan, United States
Troy, Michigan, United States
Plymouth, Minnesota, United States
Mexico, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Florham Park, New Jersey, United States
New Brunswick, New Jersey, United States
Great Neck, New York, United States
Mineola, New York, United States
New York, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Sayre, Pennsylvania, United States
Columbia, South Carolina, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Christiansburg, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Wenatchee, Washington, United States
Liverpool, New South Wales, Australia
Caboolture, Queensland, Australia
Adelaide, South Australia, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Brisbane, , Australia
Hamilton, , Australia
Sydney, , Australia
Blumenau, Santa Catarina, Brazil
Florianópolis, Santa Catarina, Brazil
Botucatu, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Santos, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Abbotsford, British Columbia, Canada
Winnipeg, Manitoba, Canada
Saint John, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
Guelph, Ontario, Canada
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saint-Charles-Borromée, Quebec, Canada
Haifa, Israel, Israel
Ẕerifin, Israel, Israel
Jerusalem, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Auckland, , New Zealand
Dunedin, , New Zealand
Hamilton, , New Zealand
Tauranga, , New Zealand
Bucharest, , Romania
Bucharest, , Romania
Craiova, , Romania
Kazan', , Russia
Krasnodar, , Russia
Moskva, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Port Elizabeth, Eastern Cape, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Durban, , South Africa
Durban, , South Africa
Dnipro, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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91494
Identifier Type: -
Identifier Source: secondary_id
NOVEL8
Identifier Type: -
Identifier Source: secondary_id
310187
Identifier Type: -
Identifier Source: org_study_id
NCT00295321
Identifier Type: -
Identifier Source: nct_alias