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Open-Label Trial of Leukine in Active Crohn's Disease
This study has been terminated.
First Received: September 13, 2005   Last Updated: July 8, 2009   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00206700
  Purpose

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.


Condition Intervention Phase
Crohn Disease
Drug: Sargramostim (Leukine, BAY86-5326)
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Open-Label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease. [ Time Frame: Not applicable for this outcome ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Crohn's disease activity [ Time Frame: After successive 8-week cycles of treatment ] [ Designated as safety issue: No ]
  • Duration of clinical remission and time to disease flare [ Time Frame: After successive cycles of sargramostim therapy ] [ Designated as safety issue: No ]
  • Patient compliance [ Time Frame: After successive cycles of sargramostim therapy ] [ Designated as safety issue: No ]

Enrollment: 378
Study Start Date: February 2003
Study Completion Date: December 2006
Arms Assigned Interventions
Arm 1: Experimental Drug: Sargramostim (Leukine, BAY86-5326)
Open Label, 8 week cycle

Detailed Description:

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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/µL or > 20,000/µL (the exclusion of subjects with ANC > 20,000/µL 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206700

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35209
United States, Arizona
Scottsdale, Arizona, United States, 85259-5404
United States, California
San Francisco, California, United States, 94115
Los Angeles, California, United States, 90067
Orange, California, United States, 92868
San Francisco, California, United States, 94117
Tarzana, California, United States, 91345
Berkeley, California, United States, 94705
United States, Colorado
Englewood, Colorado, United States, 80110
Aurora, Colorado, United States, 80045
Littleton, Colorado, United States, 80120
Lakewood, Colorado, United States, 80215
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Gainesville, Florida, United States, 32610-0254
North Miami Beach, Florida, United States, 33162
Hollywood, Florida, United States, 33021
Clearwater, Florida, United States, 33765
Jacksonville, Florida, United States, 32224
Jacksonville, Florida, United States, 32256
Winter Park, Florida, United States, 32789
Gainesville, Florida, United States, 32608-1197
Boca Raton, Florida, United States, 33486
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indianapolis, Indiana, United States, 46202
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Lexington, Kentucky, United States, 40536
Louisville, Kentucky, United States, 40202
United States, Louisiana
Slidell, Louisiana, United States, 70458
Metairie, Louisiana, United States, 70001
Lake Charles, Louisiana, United States, 70601
United States, Maryland
Towson, Maryland, United States, 21204
Hagerstown, Maryland, United States, 21740
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Boston, Massachusetts, United States, 02114-2696
United States, Michigan
Chesterfield, Michigan, United States, 48047
Troy, Michigan, United States, 48098
United States, Minnesota
Plymouth, Minnesota, United States, 55446
United States, Missouri
St. Louis, Missouri, United States, 63110
Mexico, Missouri, United States, 65265
United States, Montana
Billings, Montana, United States, 59107
United States, Nebraska
Lincoln, Nebraska, United States, 68503
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Berlin, New Jersey, United States, 08009
United States, New York
New York, New York, United States, 10029
Syracuse, New York, United States, 13210
Rochester, New York, United States, 14607
Mineola, New York, United States, 11501-3987
Great Neck, New York, United States, 11021
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
Chapel Hill, North Carolina, United States, 27514
Asheville, North Carolina, United States, 28801
Winston-Salem, North Carolina, United States, 27103
Greensboro, North Carolina, United States, 27403
Charlotte, North Carolina, United States, 28207
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati, Ohio, United States, 45242
Cincinnati, Ohio, United States, 45220
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Tulsa, Oklahoma, United States, 74104
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Portland, Oregon, United States, 97239
Portland, Oregon, United States, 97213
Portland, Oregon, United States, 97225
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213-2592
Philadelphia, Pennsylvania, United States, 19104-2699
Lancaster, Pennsylvania, United States, 17601-2644
Hanover, Pennsylvania, United States, 17331
Pittsburgh, Pennsylvania, United States, 15212
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Charleston, South Carolina, United States, 29425
Columbia, South Carolina, United States, 29203
United States, Tennessee
Nashville, Tennessee, United States, 37232
Memphis, Tennessee, United States, 38120
Bristol, Tennessee, United States, 37620
Jackson, Tennessee, United States, 38305
Kingsport, Tennessee, United States, 37660
Nashville, Tennessee, United States, 37205
Memphis, Tennessee, United States, 38119
United States, Texas
Irving, Texas, United States, 75061
San Antonio, Texas, United States, 78229
Dallas, Texas, United States, 75231
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Richmond, Virginia, United States, 23249-0002
Chesapeake, Virginia, United States, 23320
Danville, Virginia, United States, 24541
Charlottesville, Virginia, United States, 22908
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle, Washington, United States, 98195
Seattle, Washington, United States, 98104
Wenatchee, Washington, United States, 98801
Walla Walla, Washington, United States, 99362
Bellevue, Washington, United States, 98004
Seattle, Washington, United States, 98133
Spokane, Washington, United States, 99204
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Milwaukee, Wisconsin, United States, 53215
Milwaukee, Wisconsin, United States, 53226
Argentina, Capital Federal
Buenos Aires, Capital Federal, Argentina, C1264AAA
Australia
Penrith, Australia, 2751
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Concord, New South Wales, Australia, 2139
New Lambton Heights, New South Wales, Australia, 2305
Sydney, New South Wales, Australia, 2200
Sydney, New South Wales, Australia, 2050
Australia, Queensland
Brisbane, Queensland, Australia, 4029
Brisbane, Queensland, Australia, 4101
Australia, South Australia
Adelaide, South Australia, Australia, 5043
Australia, Tasmania
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Parkville, Victoria, Australia, 3050
Prahran, Victoria, Australia, 3181
Ballarat, Victoria, Australia, 3350
Frankston, Victoria, Australia, 3199
Melbourne, Victoria, Australia, 3065
Melbourne, Victoria, Australia, 3128
Australia, Western Australia
Fremantle, Western Australia, Australia, 6160
Brazil, Bahia
Salvador, Bahia, Brazil, 40110060
Brazil, Parana
Curitiba, Parana, Brazil, 80060-900
Brazil, RJ
Rio de Janeiro, RJ, Brazil, 21949 900
Brazil, RS
Porto Alegre, RS, Brazil
Brazil, SP
São Paulo, SP, Brazil, 05651-901
Sao Paulo, SP, Brazil, 05403-900
Canada
Quebec, Canada, G1S 4L8
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 2H4
Vancouver, British Columbia, Canada, V6Z 2K5
Vancouver, British Columbia, Canada, V5Z 1H2
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Toronto, Ontario, Canada, M5G 1X5
London, Ontario, Canada, N6A 5A5
Hamilton, Ontario, Canada, L8N 3Z5
Toronto, Ontario, Canada, M3N 2V7
Windsor, Ontario, Canada, N9A 1L9
Canada, Quebec
Montreal, Quebec, Canada, H3G 1A4
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H2W 1T8
Montreal, Quebec, Canada, H3T 1E2
New Zealand
Christchurch, New Zealand, 8011
Hamilton, New Zealand, 3204
Auckland, New Zealand, 1023
New Zealand, Auckland
Milford, Auckland, New Zealand, 1309
Russian Federation
Moscow, Russian Federation, 129110
Volgograd, Russian Federation, 400107
Moskva, Russian Federation, 127015
Moscow, Russian Federation, 123154
Russian Federation, Russia
Moskva, Russia, Russian Federation, 105203
Lipetsk, Russia, Russian Federation, 398055
Samara, Russia, Russian Federation, 443023
Switzerland
Basel, Switzerland, 4031
Bern, Switzerland, 3010
Switzerland, Waadt
Lausanne, Waadt, Switzerland, 1011
Ukraine
Donetsk, Ukraine, 83017
Kharkiv, Ukraine, 61001
Kiev, Ukraine, 03049
Lviv, Ukraine, 49044
Vinnitsa, Ukraine, 26014
United Kingdom
London, United Kingdom, WC1E 6AU
Sheffield, United Kingdom, S10 2JF
United Kingdom, Avon
Bristol, Avon, United Kingdom, BS2 8HW
United Kingdom, Greater London
London, Greater London, United Kingdom, W12 0HS
United Kingdom, Greater Manchester
Salford, Greater Manchester, United Kingdom, M6 8HD
United Kingdom, Lothian
Edinburgh, Lothian, United Kingdom, EH4 2XU
United Kingdom, Merseyside
Liverpool, Merseyside, United Kingdom, L7 8XP
United Kingdom, Middlesex
Harrow, Middlesex, United Kingdom, HA1 3UJ
United Kingdom, South Glamorgan
Cardiff, South Glamorgan, United Kingdom, CF14 4XW
United Kingdom, Tyne and Wear
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers: 91274, 307340, Novel 5
Study First Received: September 13, 2005
Last Updated: July 8, 2009
ClinicalTrials.gov Identifier: NCT00206700     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Additional relevant MeSH terms:
Digestive System Diseases
Antineoplastic Agents
Gastrointestinal Diseases
Therapeutic Uses
Crohn Disease
Inflammatory Bowel Diseases
Molgramostim
Intestinal Diseases
Gastroenteritis
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009