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Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00295165
Recruitment Status : Terminated
First Posted : February 23, 2006
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Sargramostim (Leukine) Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease
Study Start Date : January 2006
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: Sargramostim (Leukine)
Sargramostim 6 mcg/kg subcutaneously once daily
Other Name: BAY86-5326
Placebo Comparator: Arm 2 Drug: Placebo
Placebo subcutaneously once daily


Outcome Measures

Primary Outcome Measures :
  1. To induce clinical remission and/or clinical response following 8 weeks of treatment [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. To assess the safety profile of sargramostim (including development of antibodies against sargramostim) [ Time Frame: During study treatment ]
  2. To assess quality of life (QoL) [ Time Frame: During study treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent
  2. Male or female, age >/= 18 years
  3. Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug
  4. Moderately to severely active Crohn's disease at time of screening (i.e., CDAI greater than or equal to 220 and less than or equal to 475 points)
  5. If under treatment for Crohn's disease, medication must be stable for at least 4 weeks prior to receiving the first dose of study drug. The following therapies are allowed:

    • Oral therapy with salicylates (mesalamine, sulfasalazine, olsalazine, or balsalazide) for Crohn's disease
    • Antibiotics or probiotics for Crohn's disease
    • Topical rectal therapy with mesalamine
  6. Females of child-bearing potential:

    Negative pregnancy test within 72 hours prior to receiving the first dose of study drug

  7. Sexually-active males and females of child-bearing potential:

    Agreement to use adequate method of contraception throughout the study

  8. Ability to self-inject study drug or availability of a designee who can do so

Exclusion Criteria:

  1. Pregnancy or breast-feeding
  2. Colostomy or ileostomy
  3. Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
  4. GI surgery within 6 months prior to receiving the first dose of study drug
  5. Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
  6. Positive stool test results for any of the following:

    Bacteria:

    • Salmonella spec.
    • Shigella spec.
    • Campylobacter spec.

    Bacterial toxin:

    • Clostridium difficile

    Ova and parasites:

    • Amoeba spec.
    • Giardia spec.
    • Cryptosporidium spec.
  7. Any of the following laboratory abnormalities:

    • Serum creatinine >/= 2.0 mg/dL
    • Alkaline phosphatase (AP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >/=; 2 x the upper limit of normal
    • Hemoglobin (Hgb) < 8.0 g/dL
    • Absolute neutrophil count (ANC) </= 1,000 cells/µL or > cells 20,000/µL
  8. Planned in-patient hospitalization during the study
  9. Presence or history of cancer of any type (except treated basal cell carcinoma) or definite dysplasia of the colon within the last 5 years
  10. Use of any of the following medications during the specified period of time prior to receiving the first dose of study drug:

    At any time:

    • Recombinant human GM CSF (sargramostim or molgramostim)
    • Granulocyte colony-stimulating factor (G CSF; filgrastim or pegfilgrastim)
    • Natalizumab 8 weeks: or 5 half-lives (whichever is longer)
    • Licensed/registered and/or experimental anti-tumor necrosis factor (TNF) therapy such as infliximab or adalimumab 4 weeks:
    • 6-mercaptopurine
    • Azathioprine
    • Cyclophosphamide
    • Methotrexate
    • Mycophenolate mofetil
    • Tacrolimus
    • Cyclosporine
    • Thalidomide
    • Glucocorticoids, including budesonide and prednisone, or local glucocorticoid therapy for Crohn's disease
    • Any other immunosuppressive drugs
  11. Use of any investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug
  12. Use of nutritional therapy (parenteral nutrition or enteral nutrition with elemental or semi-elemental diets) within 4 weeks prior to receiving the first dose of study drug. If the physician judges that nutritional supplementation is needed, enteral nutritional supplements will be allowed for patients who have been receiving a stable regimen for at least 4 weeks prior to receiving the first dose of study drug and that is intended to continue through the 8 week treatment period.
  13. History of allergy to yeast products or to sargramostim or to any other excipient of the study drug formulation
  14. Active drug or alcohol abuse
  15. Clinically important co-morbid conditions unrelated to Crohn's disease as determined by the investigator
  16. Previous randomization into this study, or into any other study of the sponsor's sargramostim development program
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295165


  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
United States, California
Orange, California, United States, 92868
San Francisco, California, United States, 94117
United States, Colorado
Lakewood, Colorado, United States, 80215
Littleton, Colorado, United States, 80120
United States, District of Columbia
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Boca Raton, Florida, United States, 33486
Gainesville, Florida, United States, 32610-0254
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Lexington, Kentucky, United States, 40536
Louisville, Kentucky, United States, 40202
United States, Maryland
Hagerstown, Maryland, United States, 21740
Lutherville, Maryland, United States, 21093
Towson, Maryland, United States, 21204
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0330
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, Nebraska
Lincoln, Nebraska, United States, 68503
United States, New Jersey
Florham Park, New Jersey, United States, 07932
New Brunswick, New Jersey, United States, 08901
United States, New York
Great Neck, New York, United States, 11021
Mineola, New York, United States, 11501-3987
New York, New York, United States, 10028
Syracuse, New York, United States, 13210
United States, North Carolina
Charlotte, North Carolina, United States, 28207
Raleigh, North Carolina, United States, 27612
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45242
Cleveland, Ohio, United States, 44195
Dayton, Ohio, United States, 45440
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Columbia, South Carolina, United States, 29203
United States, Texas
San Antonio, Texas, United States, 78229
United States, Virginia
Charlottesville, Virginia, United States, 22908
Chesapeake, Virginia, United States, 23320
Christiansburg, Virginia, United States, 24073
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23249-0002
United States, Washington
Seattle, Washington, United States, 98195
Wenatchee, Washington, United States, 98801
Australia, New South Wales
Liverpool, New South Wales, Australia, 2170
Australia, Queensland
Caboolture, Queensland, Australia
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Frankston, Victoria, Australia, 3199
Melbourne, Victoria, Australia, 3084
Australia
Brisbane, Australia, QLD 4000
Hamilton, Australia, 3204
Sydney, Australia
Brazil
Blumenau, Santa Catarina, Brazil, 89010-205
Florianopolis, Santa Catarina, Brazil, 88020-210
Botucatu, SP, Brazil, 18618-970
Sao Paulo, SP, Brazil, 04023-900
Santos, Brazil, 11075-900
Sao Paulo, Brazil, 0122-1020
Bulgaria
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1527
Varna, Bulgaria, 9010
Canada, British Columbia
Abbotsford, British Columbia, Canada, V2S 3N5
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, New Brunswick
St. John, New Brunswick, Canada, E2K 1J5
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Guelph, Ontario, Canada, N1H 3R3
Kingston, Ontario, Canada, K7L 5G2
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Montreal, Quebec, Canada, H3H 1V4
St-Charles-Borromee, Quebec, Canada, J6E 2C3
Canada
Quebec, Canada, G1R 2J6
Israel
Haifa, Israel, 31048
Jerusalem, Israel, 91120
Rehovot, Israel, 76100
Tel Aviv, Israel, 64299
Zerifin, Israel, 70300
New Zealand
Auckland, New Zealand, 0622
Dunedin, New Zealand, 9016
Hamilton, New Zealand, 3204
Tauranga, New Zealand
Romania
Bucharest, Romania, 011025
Bucharest, Romania
Craiova, Romania, 200670
Russian Federation
Kazan, Russian Federation, 420011
Krasnodar, Russian Federation, 350086
Moskva, Russian Federation, 119992
Sankt-Peterburg, Russian Federation
St. Petersburg, Russian Federation, 194017
St. Petersburg, Russian Federation, 194291
St. Petersburg, Russian Federation, 197110
South Africa
Port Elizabeth, Eastern Cape, South Africa, 6057
Johannesburg, Gauteng, South Africa, 2193
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa, 7463
Cape Town, Western Cape, South Africa, 7530
Cape Town, Western Cape, South Africa, 7708
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa, 7130
Durban, South Africa, 4001
Durban, South Africa
Ukraine
Dnepropetrovsk, Ukraine
Ivano-Frankovsk, Ukraine
Kharkiv, Ukraine, 61039
Kiev, Ukraine
Lviv, Ukraine, 79013
Zaporozhye, Ukraine
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information

Additional Information:
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00295165     History of Changes
Obsolete Identifiers: NCT00295321
Other Study ID Numbers: 310187
91494
NOVEL8
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases