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Open-label Trial of Leukine in Active 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)

Phase: Phase 2

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 establish a safety profile sargramostim administered in 8 week cycles to adult patients with active Crohn's disease.

Clinical Details

Official title: Open-label Trial of Leukine« (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease.

Secondary outcome:

Crohn's disease activity

Duration of clinical remission and time to disease flare

Patient compliance

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:

- 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450 points) if completely withdrawn from CS use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 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/┬ÁL or > 20,000/┬ÁL (the exclusion of subjects with ANC > 20,000/┬ÁL 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)

Locations and Contacts

Penrith 2751, Australia

Quebec G1S 4L8, Canada

Auckland 1023, New Zealand

Christchurch 8011, New Zealand

Hamilton 3204, New Zealand

Moscow 123154, Russian Federation

Moscow 129110, Russian Federation

Moskva 127015, Russian Federation

Volgograd 400107, Russian Federation

Basel 4031, Switzerland

Bern 3010, Switzerland

Donetsk 83017, Ukraine

Kharkiv 61001, Ukraine

Kiev 03049, Ukraine

Lviv 49044, Ukraine

Vinnitsa 26014, Ukraine

London WC1E 6AU, United Kingdom

Sheffield S10 2JF, United Kingdom

Birmingham, Alabama 35209, United States

Edmonton, Alberta T5H 4B9, Canada

Edmonton, Alberta T6G 2B7, Canada

Scottsdale, Arizona 85259-5404, United States

Milford, Auckland 1309, New Zealand

Garran, Australian Capital Territory 2605, Australia

Bristol, Avon BS2 8HW, United Kingdom

Salvador, Bahia 40110060, Brazil

Kelowna, British Columbia V1Y 2H4, Canada

Vancouver, British Columbia V5Z 1H2, Canada

Vancouver, British Columbia V6Z 2K5, Canada

Berkeley, California 94705, United States

Los Angeles, California 90067, United States

Orange, California 92868, United States

San Francisco, California 94115, United States

San Francisco, California 94117, United States

Tarzana, California 91345, United States

Buenos Aires, Capital Federal C1264AAA, Argentina

Aurora, Colorado 80045, United States

Englewood, Colorado 80110, United States

Lakewood, Colorado 80215, United States

Littleton, Colorado 80120, United States

Washington, District of Columbia 20010, United States

Boca Raton, Florida 33486, United States

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London, Greater London W12 0HS, United Kingdom

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Chicago, Illinois 60637-1470, United States

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Lexington, Kentucky 40536, United States

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Edinburgh, Lothian EH4 2XU, United Kingdom

Lake Charles, Louisiana 70601, United States

Metairie, Louisiana 70001, United States

Slidell, Louisiana 70458, United States

Winnipeg, Manitoba R3A 1R9, Canada

Annapolis, Maryland 21401, United States

Hagerstown, Maryland 21740, United States

Towson, Maryland 21204, United States

Boston, Massachusetts 02114-2696, United States

Liverpool, Merseyside L7 8XP, United Kingdom

Chesterfield, Michigan 48047, United States

Troy, Michigan 48098, United States

Harrow, Middlesex HA1 3UJ, United Kingdom

Plymouth, Minnesota 55446, United States

Mexico, Missouri 65265, United States

St. Louis, Missouri 63110, United States

Billings, Montana 59107, United States

Lincoln, Nebraska 68503, United States

Lebanon, New Hampshire 03756-0001, United States

Berlin, New Jersey 08009, United States

Concord, New South Wales 2139, Australia

New Lambton Heights, New South Wales 2305, Australia

Sydney, New South Wales 2050, Australia

Sydney, New South Wales 2200, Australia

Great Neck, New York 11021, United States

Mineola, New York 11501-3987, United States

New York, New York 10029, United States

Rochester, New York 14607, United States

Syracuse, New York 13210, United States

Asheville, North Carolina 28801, United States

Chapel Hill, North Carolina 27514, United States

Charlotte, North Carolina 28207, United States

Greensboro, North Carolina 27403, United States

Wilmington, North Carolina 28401, United States

Winston-Salem, North Carolina 27103, United States

Winston-Salem, North Carolina 27157, United States

Cincinnati, Ohio 45219, United States

Cincinnati, Ohio 45220, United States

Cincinnati, Ohio 45242, United States

Oklahoma City, Oklahoma 73104, United States

Tulsa, Oklahoma 74104, United States

Hamilton, Ontario L8N 3Z5, Canada

London, Ontario N6A 5A5, Canada

Toronto, Ontario M5G 1X5, Canada

Toronto, Ontario M3N 2V7, Canada

Windsor, Ontario N9A 1L9, Canada

Portland, Oregon 97213, United States

Portland, Oregon 97225, United States

Portland, Oregon 97239, United States

Curitiba, Parana 80060-900, Brazil

Hanover, Pennsylvania 17331, United States

Lancaster, Pennsylvania 17601-2644, United States

Philadelphia, Pennsylvania 19104-2699, United States

Pittsburgh, Pennsylvania 15212, United States

Pittsburgh, Pennsylvania 15213-2592, United States

Sayre, Pennsylvania 18840, United States

Montreal, Quebec H2W 1T8, Canada

Montreal, Quebec H3A 1A1, Canada

Montreal, Quebec H3G 1A4, Canada

Montreal, Quebec H3T 1E2, Canada

Brisbane, Queensland 4029, Australia

Brisbane, Queensland 4101, Australia

Rio de Janeiro, RJ 21949 900, Brazil

Porto Alegre, RS, Brazil

Lipetsk, Russia 398055, Russian Federation

Moskva, Russia 105203, Russian Federation

Samara, Russia 443023, Russian Federation

Sao Paulo, SP 05403-900, Brazil

São Paulo, SP 05651-901, Brazil

Adelaide, South Australia 5043, Australia

Charleston, South Carolina 29425, United States

Columbia, South Carolina 29203, United States

Cardiff, South Glamorgan CF14 4XW, United Kingdom

Launceston, Tasmania 7250, Australia

Bristol, Tennessee 37620, United States

Jackson, Tennessee 38305, United States

Kingsport, Tennessee 37660, United States

Memphis, Tennessee 38119, United States

Memphis, Tennessee 38120, United States

Nashville, Tennessee 37205, United States

Nashville, Tennessee 37232, United States

Dallas, Texas 75231, United States

Irving, Texas 75061, United States

San Antonio, Texas 78229, United States

Newcastle Upon Tyne, Tyne and Wear NE1 4LP, United Kingdom

Salt Lake City, Utah 84132, United States

Ballarat, Victoria 3350, Australia

Frankston, Victoria 3199, Australia

Melbourne, Victoria 3065, Australia

Melbourne, Victoria 3128, Australia

Parkville, Victoria 3050, Australia

Prahran, Victoria 3181, Australia

Charlottesville, Virginia 22908, United States

Chesapeake, Virginia 23320, United States

Danville, Virginia 24541, United States

Norfolk, Virginia 23502, United States

Richmond, Virginia 23249-0002, United States

Lausanne, Waadt 1011, Switzerland

Bellevue, Washington 98004, United States

Seattle, Washington 98195, United States

Seattle, Washington 98133, United States

Seattle, Washington 98104, United States

Spokane, Washington 99204, United States

Walla Walla, Washington 99362, United States

Wenatchee, Washington 98801, United States

Fremantle, Western Australia 6160, Australia

Madison, Wisconsin 53792, United States

Milwaukee, Wisconsin 53226, United States

Milwaukee, Wisconsin 53215, United States

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Starting date: February 2003
Last updated: December 2, 2013

Page last updated: August 23, 2015

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