The purpose of this study is to evaluate if Leukine can induce clinical response or
remission in patients with Crohn's disease.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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
Brisbane QLD 4000, Australia
Hamilton 3204, Australia
Sydney, Australia
Santos 11075-900, Brazil
Sao Paulo 0122-1020, Brazil
Sofia 1233, Bulgaria
Sofia 1431, Bulgaria
Sofia 1527, Bulgaria
Varna 9010, Bulgaria
Quebec G1R 2J6, Canada
Haifa 31048, Israel
Jerusalem 91120, Israel
Rehovot 76100, Israel
Tel Aviv 64299, Israel
Zerifin 70300, Israel
Auckland 0622, New Zealand
Dunedin 9016, New Zealand
Hamilton 3204, New Zealand
Tauranga, New Zealand
Bucharest 011025, Romania
Bucharest, Romania
Craiova 200670, Romania
Kazan 420011, Russian Federation
Krasnodar 350086, Russian Federation
Moskva 119992, Russian Federation
Sankt-Peterburg, Russian Federation
St. Petersburg 194017, Russian Federation
St. Petersburg 194291, Russian Federation
St. Petersburg 197110, Russian Federation
Durban 4001, South Africa
Durban, South Africa
Dnepropetrovsk, Ukraine
Ivano-Frankovsk, Ukraine
Kharkiv 61039, Ukraine
Kiev, Ukraine
Lviv 79013, Ukraine
Zaporozhye, Ukraine
Huntsville, Alabama 35801, United States
Abbotsford, British Columbia V2S 3N5, Canada
Orange, California 92868, United States
San Francisco, California 94117, United States
Lakewood, Colorado 80215, United States
Littleton, Colorado 80120, United States
Washington, District of Columbia 20007-2197, United States
Port Elizabeth, Eastern Cape 6057, South Africa
Boca Raton, Florida 33486, United States
Gainesville, Florida 32610-0254, United States
Johannesburg, Gauteng 2193, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Atlanta, Georgia 30342, United States
Indianapolis, Indiana 46202, United States
Lexington, Kentucky 40536, United States
Louisville, Kentucky 40202, United States
Winnipeg, Manitoba R3C 0N2, Canada
Hagerstown, Maryland 21740, United States
Lutherville, Maryland 21093, United States
Towson, Maryland 21204, United States
Ann Arbor, Michigan 48109-0330, United States
Chesterfield, Michigan 48047, United States
Troy, Michigan 48098, United States
Plymouth, Minnesota 55446, United States
Mexico, Missouri 65265, United States
St. Louis, Missouri 63110, United States
Lincoln, Nebraska 68503, United States
St. John, New Brunswick E2K 1J5, Canada
Florham Park, New Jersey 07932, United States
New Brunswick, New Jersey 08901, United States
Liverpool, New South Wales 2170, Australia
Great Neck, New York 11021, United States
Mineola, New York 11501-3987, United States
New York, New York 10028, United States
Syracuse, New York 13210, United States
St. John's, Newfoundland and Labrador A1B 3V6, Canada
Charlotte, North Carolina 28207, United States
Raleigh, North Carolina 27612, United States
Winston-Salem, North Carolina 27157, United States
Cincinnati, Ohio 45219, United States
Cincinnati, Ohio 45242, United States
Cleveland, Ohio 44195, United States
Dayton, Ohio 45440, United States
Oklahoma City, Oklahoma 73104, United States
Tulsa, Oklahoma 74104, United States
Guelph, Ontario N1H 3R3, Canada
Kingston, Ontario K7L 5G2, Canada
Ottawa, Ontario K1H 8L6, Canada
Sayre, Pennsylvania 18840, United States
Montreal, Quebec H3H 1V4, Canada
St-Charles-Borromee, Quebec J6E 2C3, Canada
Caboolture, Queensland, Australia
Botucatu, SP 18618-970, Brazil
Sao Paulo, SP 04023-900, Brazil
Blumenau, Santa Catarina 89010-205, Brazil
Florianopolis, Santa Catarina 88020-210, Brazil
Adelaide, South Australia 5000, Australia
Columbia, South Carolina 29203, United States
San Antonio, Texas 78229, United States
Frankston, Victoria 3199, Australia
Melbourne, Victoria 3084, Australia
Charlottesville, Virginia 22908, United States
Chesapeake, Virginia 23320, United States
Christiansburg, Virginia 24073, United States
Norfolk, Virginia 23502, United States
Richmond, Virginia 23249-0002, United States
Seattle, Washington 98195, United States
Wenatchee, Washington 98801, United States
Cape Town, Western Cape 7463, South Africa
Cape Town, Western Cape 7530, South Africa
Cape Town, Western Cape 7708, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape 7130, South Africa