Clinical trial NCT00295165: Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: To induce clinical remission and/or clinical response following 8 weeks of treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess the safety profile of sargramostim (including development of antibodies against sargramostim)
timeFrame: During study treatment
measure: To assess quality of life (QoL)
timeFrame: During study treatment
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Orange
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Boca Raton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Hagerstown
country: United States
state: Maryland
city: Lutherville
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Chesterfield
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Plymouth
country: United States
state: Minnesota
city: Mexico
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Florham Park
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Sayre
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Christiansburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Wenatchee
country: United States
state: Washington
city: Liverpool
country: Australia
state: New South Wales
city: Caboolture
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Frankston
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Brisbane
country: Australia
city: Hamilton
country: Australia
city: Sydney
country: Australia
city: Blumenau
country: Brazil
state: Santa Catarina
city: Florianopolis
country: Brazil
state: Santa Catarina
city: Botucatu
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Santos
country: Brazil
city: Sao Paulo
country: Brazil
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Abbotsford
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St. John
country: Canada
state: New Brunswick
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Guelph
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: St-Charles-Borromee
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
city: Auckland
country: New Zealand
city: Dunedin
country: New Zealand
city: Hamilton
country: New Zealand
city: Tauranga
country: New Zealand
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Craiova
country: Romania
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moskva
country: Russian Federation
city: Sankt-Peterburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Port Elizabeth
country: South Africa
state: Eastern Cape
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Somerset West
country: South Africa
state: Western Cape
city: Durban
country: South Africa
city: Durban
country: South Africa
city: Dnepropetrovsk
country: Ukraine
city: Ivano-Frankovsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Zaporozhye
country: Ukraine
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: