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Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn Disease

Intervention: Sargramostim (Leukine) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

Clinical Details

Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6g Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To induce clinical remission and/or clinical response following 8 weeks of treatment

Secondary outcome:

To assess the safety profile of sargramostim (including development of antibodies against sargramostim)

To assess quality of life (QoL)

Detailed description: On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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) 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

Locations and Contacts

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

Additional Information

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Starting date: January 2006
Last updated: December 2, 2013

Page last updated: August 23, 2015

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