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

December 2, 2013 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

378

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1264AAA
  • Australia
      • Penrith, Australia, 2751
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Concord, New South Wales, Australia, 2139
      • New Lambton Heights, New South Wales, Australia, 2305
      • Sydney, New South Wales, Australia, 2050
      • Sydney, New South Wales, Australia, 2200
    • Queensland
      • Brisbane, Queensland, Australia, 4029
      • Brisbane, Queensland, Australia, 4101
    • South Australia
      • Adelaide, South Australia, Australia, 5043
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
    • 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
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40110060
    • Parana
      • Curitiba, Parana, Brazil, 80060-900
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21949 900
    • RS
      • Porto Alegre, RS, Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-900
      • São Paulo, SP, Brazil, 05651-901
  • Canada
      • Quebec, Canada, G1S 4L8
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
      • Edmonton, Alberta, Canada, T5H 4B9
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
      • Vancouver, British Columbia, Canada, V5Z 1H2
      • Vancouver, British Columbia, Canada, V6Z 2K5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • 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
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
      • Montreal, Quebec, Canada, H3T 1E2
      • Montreal, Quebec, Canada, H3G 1A4
      • Montreal, Quebec, Canada, H2W 1T8
  • New Zealand
      • Auckland, New Zealand, 1023
      • Christchurch, New Zealand, 8011
      • Hamilton, New Zealand, 3204
    • Auckland
      • Milford, Auckland, New Zealand, 1309
  • Russian Federation
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 123154
      • Moskva, Russian Federation, 127015
      • Volgograd, Russian Federation, 400107
    • Russia
      • Lipetsk, Russia, Russian Federation, 398055
      • Moskva, Russia, Russian Federation, 105203
      • Samara, Russia, Russian Federation, 443023
  • Switzerland
      • Basel, Switzerland, 4031
      • Bern, Switzerland, 3010
    • 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
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8HW
    • Greater London
      • London, Greater London, United Kingdom, W12 0HS
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH4 2XU
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
    • California
      • Berkeley, California, United States, 94705
      • Los Angeles, California, United States, 90067
      • Orange, California, United States, 92868
      • San Francisco, California, United States, 94115
      • San Francisco, California, United States, 94117
      • Tarzana, California, United States, 91345
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Englewood, Colorado, United States, 80110
      • Lakewood, Colorado, United States, 80215
      • Littleton, Colorado, United States, 80120
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Clearwater, Florida, United States, 33765
      • Gainesville, Florida, United States, 32610-0254
      • Gainesville, Florida, United States, 32608-1197
      • Hollywood, Florida, United States, 33021
      • Jacksonville, Florida, United States, 32256
      • Jacksonville, Florida, United States, 32224
      • North Miami Beach, Florida, United States, 33162
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
    • Indiana
      • Indianapolis, Indiana, United States, 46202
      • Indianapolis, Indiana, United States, 46237
    • Kentucky
      • Lexington, Kentucky, United States, 40536
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
      • Metairie, Louisiana, United States, 70001
      • Slidell, Louisiana, United States, 70458
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Hagerstown, Maryland, United States, 21740
      • Towson, Maryland, United States, 21204
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2696
    • Michigan
      • Chesterfield, Michigan, United States, 48047
      • Troy, Michigan, United States, 48098
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
    • Missouri
      • Mexico, Missouri, United States, 65265
      • St. Louis, Missouri, United States, 63110
    • Montana
      • Billings, Montana, United States, 59107
    • Nebraska
      • Lincoln, Nebraska, United States, 68503
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • 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
    • 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, 27103
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45219
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Portland, Oregon, United States, 97239
      • Portland, Oregon, United States, 97225
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Hanover, Pennsylvania, United States, 17331
      • Lancaster, Pennsylvania, United States, 17601-2644
      • Philadelphia, Pennsylvania, United States, 19104-2699
      • Pittsburgh, Pennsylvania, United States, 15212
      • Pittsburgh, Pennsylvania, United States, 15213-2592
      • Sayre, Pennsylvania, United States, 18840
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Columbia, South Carolina, United States, 29203
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Jackson, Tennessee, United States, 38305
      • Kingsport, Tennessee, United States, 37660
      • Memphis, Tennessee, United States, 38119
      • Memphis, Tennessee, United States, 38120
      • Nashville, Tennessee, United States, 37232
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Dallas, Texas, United States, 75231
      • Irving, Texas, United States, 75061
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • 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
    • Washington
      • Bellevue, Washington, United States, 98004
      • Seattle, Washington, United States, 98133
      • Seattle, Washington, United States, 98104
      • Seattle, Washington, United States, 98195
      • Spokane, Washington, United States, 99204
      • Walla Walla, Washington, United States, 99362
      • Wenatchee, Washington, United States, 98801
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Milwaukee, Wisconsin, United States, 53226
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Sargramostim (Leukine)
Open Label, 8 week cycle
Other Names:
  • BAY86-5326

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Not applicable for this outcome

Secondary Outcome Measures

Outcome Measure
Time Frame
Crohn's disease activity
Time Frame: After successive 8-week cycles of treatment
After successive 8-week cycles of treatment
Duration of clinical remission and time to disease flare
Time Frame: After successive cycles of sargramostim therapy
After successive cycles of sargramostim therapy
Patient compliance
Time Frame: After successive cycles of sargramostim therapy
After successive cycles of sargramostim therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307340
  • 91274
  • Novel 5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn Disease

Clinical Trials on Sargramostim (Leukine)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe