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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00295165
First received: February 21, 2006
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Crohn Disease
Drug: Sargramostim (Leukine)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

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

Enrollment: 33
Study Start Date: January 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295165

  Show 111 Study Locations
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: NCT00295165     History of Changes
Obsolete Identifiers: NCT00295321
Other Study ID Numbers: 310187, 91494, NOVEL8
Study First Received: February 21, 2006
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Israel: Israeli Health Ministry Pharmaceutical Administration
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
Ukraine: Ministry of Health

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

ClinicalTrials.gov processed this record on October 16, 2014