Open-label Trial of Leukine in Active Crohn's Disease

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00206700
First received: September 13, 2005
Last updated: December 2, 2013
Last verified: December 2013
  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)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Sanofi:

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
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sargramostim (Leukine)
Open Label, 8 week cycle
Other Name: BAY86-5326

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

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
Berkeley, California, United States, 94705
Los Angeles, California, United States, 90067
Orange, California, United States, 92868
San Francisco, California, United States, 94117
San Francisco, California, United States, 94115
Tarzana, California, United States, 91345
United States, Colorado
Aurora, Colorado, United States, 80045
Englewood, Colorado, United States, 80110
Lakewood, Colorado, United States, 80215
Littleton, Colorado, United States, 80120
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Boca Raton, Florida, United States, 33486
Clearwater, Florida, United States, 33765
Gainesville, Florida, United States, 32608-1197
Gainesville, Florida, United States, 32610-0254
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32224
Jacksonville, Florida, United States, 32256
North Miami Beach, Florida, United States, 33162
Winter Park, Florida, United States, 32789
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
Lake Charles, Louisiana, United States, 70601
Metairie, Louisiana, United States, 70001
Slidell, Louisiana, United States, 70458
United States, Maryland
Annapolis, Maryland, United States, 21401
Hagerstown, Maryland, United States, 21740
Towson, Maryland, United States, 21204
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
Mexico, Missouri, United States, 65265
St. Louis, Missouri, United States, 63110
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
Great Neck, New York, United States, 11021
Mineola, New York, United States, 11501-3987
New York, New York, United States, 10029
Rochester, New York, United States, 14607
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville, North Carolina, United States, 28801
Chapel Hill, North Carolina, United States, 27514
Charlotte, North Carolina, United States, 28207
Greensboro, North Carolina, United States, 27403
Wilmington, North Carolina, United States, 28401
Winston-Salem, North Carolina, United States, 27157
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45242
Cincinnati, Ohio, United States, 45220
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Portland, Oregon, United States, 97239
Portland, Oregon, United States, 97213
Portland, Oregon, United States, 97225
United States, Pennsylvania
Hanover, Pennsylvania, United States, 17331
Lancaster, Pennsylvania, United States, 17601-2644
Philadelphia, Pennsylvania, United States, 19104-2699
Pittsburgh, Pennsylvania, United States, 15213-2592
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
Bristol, Tennessee, United States, 37620
Jackson, Tennessee, United States, 38305
Kingsport, Tennessee, United States, 37660
Memphis, Tennessee, United States, 38120
Memphis, Tennessee, United States, 38119
Nashville, Tennessee, United States, 37232
Nashville, Tennessee, United States, 37205
United States, Texas
Dallas, Texas, United States, 75231
Irving, Texas, United States, 75061
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Charlottesville, Virginia, United States, 22908
Chesapeake, Virginia, United States, 23320
Danville, Virginia, United States, 24541
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23249-0002
United States, Washington
Bellevue, Washington, United States, 98004
Seattle, Washington, United States, 98195
Seattle, Washington, United States, 98133
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99204
Walla Walla, Washington, United States, 99362
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Milwaukee, Wisconsin, United States, 53215
Milwaukee, Wisconsin, United States, 53226
Argentina
Buenos Aires, Capital Federal, Argentina, C1264AAA
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
Ballarat, Victoria, Australia, 3350
Frankston, Victoria, Australia, 3199
Melbourne, Victoria, Australia, 3128
Melbourne, Victoria, Australia, 3065
Parkville, Victoria, Australia, 3050
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Fremantle, Western Australia, Australia, 6160
Australia
Penrith, Australia, 2751
Brazil
Salvador, Bahia, Brazil, 40110060
Curitiba, Parana, Brazil, 80060-900
Rio de Janeiro, RJ, Brazil, 21949 900
Porto Alegre, RS, Brazil
Sao Paulo, SP, Brazil, 05403-900
São Paulo, SP, Brazil, 05651-901
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
Hamilton, Ontario, Canada, L8N 3Z5
London, Ontario, Canada, N6A 5A5
Toronto, Ontario, Canada, M5G 1X5
Toronto, Ontario, Canada, M3N 2V7
Windsor, Ontario, Canada, N9A 1L9
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H3G 1A4
Montreal, Quebec, Canada, H2W 1T8
Montreal, Quebec, Canada, H3T 1E2
Canada
Quebec, Canada, G1S 4L8
New Zealand
Milford, Auckland, New Zealand, 1309
Auckland, New Zealand, 1023
Christchurch, New Zealand, 8011
Hamilton, New Zealand, 3204
Russian Federation
Lipetsk, Russia, Russian Federation, 398055
Moskva, Russia, Russian Federation, 105203
Samara, Russia, Russian Federation, 443023
Moscow, Russian Federation, 123154
Moscow, Russian Federation, 129110
Moskva, Russian Federation, 127015
Volgograd, Russian Federation, 400107
Switzerland
Lausanne, Waadt, Switzerland, 1011
Basel, Switzerland, 4031
Bern, Switzerland, 3010
Ukraine
Donetsk, Ukraine, 83017
Kharkiv, Ukraine, 61001
Kiev, Ukraine, 03049
Lviv, Ukraine, 49044
Vinnitsa, Ukraine, 26014
United Kingdom
Bristol, Avon, United Kingdom, BS2 8HW
London, Greater London, United Kingdom, W12 0HS
Salford, Greater Manchester, United Kingdom, M6 8HD
Edinburgh, Lothian, United Kingdom, EH4 2XU
Liverpool, Merseyside, United Kingdom, L7 8XP
Harrow, Middlesex, United Kingdom, HA1 3UJ
Cardiff, South Glamorgan, United Kingdom, CF14 4XW
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
London, United Kingdom, WC1E 6AU
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00206700     History of Changes
Obsolete Identifiers: NCT00185471
Other Study ID Numbers: 307340, 91274, Novel 5
Study First Received: September 13, 2005
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on April 17, 2014