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

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT00206700
Collaborator
(none)
378
Enrollment
167
Locations
1
Arm
46
Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sargramostim (Leukine)
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
378 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2003
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Drug: Sargramostim (Leukine)
Open Label, 8 week cycle
Other Names:
  • BAY86-5326

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease. [Not applicable for this outcome]

    Secondary Outcome Measures

    1. Crohn's disease activity [After successive 8-week cycles of treatment]

    2. Duration of clinical remission and time to disease flare [After successive cycles of sargramostim therapy]

    3. Patient compliance [After successive cycles of sargramostim therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35209
    2 Scottsdale Arizona United States 85259-5404
    3 Berkeley California United States 94705
    4 Los Angeles California United States 90067
    5 Orange California United States 92868
    6 San Francisco California United States 94115
    7 San Francisco California United States 94117
    8 Tarzana California United States 91345
    9 Aurora Colorado United States 80045
    10 Englewood Colorado United States 80110
    11 Lakewood Colorado United States 80215
    12 Littleton Colorado United States 80120
    13 Washington District of Columbia United States 20010
    14 Boca Raton Florida United States 33486
    15 Clearwater Florida United States 33765
    16 Gainesville Florida United States 32608-1197
    17 Gainesville Florida United States 32610-0254
    18 Hollywood Florida United States 33021
    19 Jacksonville Florida United States 32224
    20 Jacksonville Florida United States 32256
    21 North Miami Beach Florida United States 33162
    22 Winter Park Florida United States 32789
    23 Atlanta Georgia United States 30342
    24 Chicago Illinois United States 60637-1470
    25 Indianapolis Indiana United States 46202
    26 Indianapolis Indiana United States 46237
    27 Lexington Kentucky United States 40536
    28 Louisville Kentucky United States 40202
    29 Lake Charles Louisiana United States 70601
    30 Metairie Louisiana United States 70001
    31 Slidell Louisiana United States 70458
    32 Annapolis Maryland United States 21401
    33 Hagerstown Maryland United States 21740
    34 Towson Maryland United States 21204
    35 Boston Massachusetts United States 02114-2696
    36 Chesterfield Michigan United States 48047
    37 Troy Michigan United States 48098
    38 Plymouth Minnesota United States 55446
    39 Mexico Missouri United States 65265
    40 St. Louis Missouri United States 63110
    41 Billings Montana United States 59107
    42 Lincoln Nebraska United States 68503
    43 Lebanon New Hampshire United States 03756-0001
    44 Berlin New Jersey United States 08009
    45 Great Neck New York United States 11021
    46 Mineola New York United States 11501-3987
    47 New York New York United States 10029
    48 Rochester New York United States 14607
    49 Syracuse New York United States 13210
    50 Asheville North Carolina United States 28801
    51 Chapel Hill North Carolina United States 27514
    52 Charlotte North Carolina United States 28207
    53 Greensboro North Carolina United States 27403
    54 Wilmington North Carolina United States 28401
    55 Winston-Salem North Carolina United States 27103
    56 Winston-Salem North Carolina United States 27157
    57 Cincinnati Ohio United States 45219
    58 Cincinnati Ohio United States 45220
    59 Cincinnati Ohio United States 45242
    60 Oklahoma City Oklahoma United States 73104
    61 Tulsa Oklahoma United States 74104
    62 Portland Oregon United States 97213
    63 Portland Oregon United States 97225
    64 Portland Oregon United States 97239
    65 Hanover Pennsylvania United States 17331
    66 Lancaster Pennsylvania United States 17601-2644
    67 Philadelphia Pennsylvania United States 19104-2699
    68 Pittsburgh Pennsylvania United States 15212
    69 Pittsburgh Pennsylvania United States 15213-2592
    70 Sayre Pennsylvania United States 18840
    71 Charleston South Carolina United States 29425
    72 Columbia South Carolina United States 29203
    73 Bristol Tennessee United States 37620
    74 Jackson Tennessee United States 38305
    75 Kingsport Tennessee United States 37660
    76 Memphis Tennessee United States 38119
    77 Memphis Tennessee United States 38120
    78 Nashville Tennessee United States 37205
    79 Nashville Tennessee United States 37232
    80 Dallas Texas United States 75231
    81 Irving Texas United States 75061
    82 San Antonio Texas United States 78229
    83 Salt Lake City Utah United States 84132
    84 Charlottesville Virginia United States 22908
    85 Chesapeake Virginia United States 23320
    86 Danville Virginia United States 24541
    87 Norfolk Virginia United States 23502
    88 Richmond Virginia United States 23249-0002
    89 Bellevue Washington United States 98004
    90 Seattle Washington United States 98104
    91 Seattle Washington United States 98133
    92 Seattle Washington United States 98195
    93 Spokane Washington United States 99204
    94 Walla Walla Washington United States 99362
    95 Wenatchee Washington United States 98801
    96 Madison Wisconsin United States 53792
    97 Milwaukee Wisconsin United States 53215
    98 Milwaukee Wisconsin United States 53226
    99 Buenos Aires Capital Federal Argentina C1264AAA
    100 Garran Australian Capital Territory Australia 2605
    101 Concord New South Wales Australia 2139
    102 New Lambton Heights New South Wales Australia 2305
    103 Sydney New South Wales Australia 2050
    104 Sydney New South Wales Australia 2200
    105 Brisbane Queensland Australia 4029
    106 Brisbane Queensland Australia 4101
    107 Adelaide South Australia Australia 5043
    108 Launceston Tasmania Australia 7250
    109 Ballarat Victoria Australia 3350
    110 Frankston Victoria Australia 3199
    111 Melbourne Victoria Australia 3065
    112 Melbourne Victoria Australia 3128
    113 Parkville Victoria Australia 3050
    114 Prahran Victoria Australia 3181
    115 Fremantle Western Australia Australia 6160
    116 Penrith Australia 2751
    117 Salvador Bahia Brazil 40110060
    118 Curitiba Parana Brazil 80060-900
    119 Rio de Janeiro RJ Brazil 21949 900
    120 Porto Alegre RS Brazil
    121 Sao Paulo SP Brazil 05403-900
    122 São Paulo SP Brazil 05651-901
    123 Edmonton Alberta Canada T5H 4B9
    124 Edmonton Alberta Canada T6G 2B7
    125 Kelowna British Columbia Canada V1Y 2H4
    126 Vancouver British Columbia Canada V5Z 1H2
    127 Vancouver British Columbia Canada V6Z 2K5
    128 Winnipeg Manitoba Canada R3A 1R9
    129 Hamilton Ontario Canada L8N 3Z5
    130 London Ontario Canada N6A 5A5
    131 Toronto Ontario Canada M3N 2V7
    132 Toronto Ontario Canada M5G 1X5
    133 Windsor Ontario Canada N9A 1L9
    134 Montreal Quebec Canada H2W 1T8
    135 Montreal Quebec Canada H3A 1A1
    136 Montreal Quebec Canada H3G 1A4
    137 Montreal Quebec Canada H3T 1E2
    138 Quebec Canada G1S 4L8
    139 Milford Auckland New Zealand 1309
    140 Auckland New Zealand 1023
    141 Christchurch New Zealand 8011
    142 Hamilton New Zealand 3204
    143 Lipetsk Russia Russian Federation 398055
    144 Moskva Russia Russian Federation 105203
    145 Samara Russia Russian Federation 443023
    146 Moscow Russian Federation 123154
    147 Moscow Russian Federation 129110
    148 Moskva Russian Federation 127015
    149 Volgograd Russian Federation 400107
    150 Lausanne Waadt Switzerland 1011
    151 Basel Switzerland 4031
    152 Bern Switzerland 3010
    153 Donetsk Ukraine 83017
    154 Kharkiv Ukraine 61001
    155 Kiev Ukraine 03049
    156 Lviv Ukraine 49044
    157 Vinnitsa Ukraine 26014
    158 Bristol Avon United Kingdom BS2 8HW
    159 London Greater London United Kingdom W12 0HS
    160 Salford Greater Manchester United Kingdom M6 8HD
    161 Edinburgh Lothian United Kingdom EH4 2XU
    162 Liverpool Merseyside United Kingdom L7 8XP
    163 Harrow Middlesex United Kingdom HA1 3UJ
    164 Cardiff South Glamorgan United Kingdom CF14 4XW
    165 Newcastle Upon Tyne Tyne and Wear United Kingdom NE1 4LP
    166 London United Kingdom WC1E 6AU
    167 Sheffield United Kingdom S10 2JF

    Sponsors and Collaborators

    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Medical Monitor, Genzyme, a Sanofi Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00206700
    Other Study ID Numbers:
    • 307340
    • 91274
    • Novel 5
    • NCT00185471
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Dec 4, 2013
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Crohn Disease
    Sargramostim

    Study Results

    No Results Posted as of Dec 4, 2013