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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00206700
First received: September 13, 2005
Last updated: December 2, 2013
Last verified: December 2013

September 13, 2005
December 2, 2013
February 2003
December 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Establish a safety provide for long-term repeated cycles of sargramostim administered to patients with Crohn's disease
Complete list of historical versions of study NCT00206700 on ClinicalTrials.gov Archive Site
  • Crohn's disease activity [ Time Frame: After successive 8-week cycles of treatment ] [ Designated as safety issue: No ]
  • Duration of clinical remission and time to disease flare [ Time Frame: After successive cycles of sargramostim therapy ] [ Designated as safety issue: No ]
  • Patient compliance [ Time Frame: After successive cycles of sargramostim therapy ] [ Designated as safety issue: No ]
  • - Crohn’s disease activity in after successive 8-week cycles of treatment
  • - Duration of clinical remission and time to disease flare after successive cycles of sargramostim therapy
  • - Patient compliance with successive cycles of the 8 week treatment regimen
  • - Changes in concomitant Crohn’s disease medication use over the treatment period and through the follow-up period
Not Provided
Not Provided
 
Open-label Trial of Leukine in Active Crohn's Disease
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn Disease
Drug: Sargramostim (Leukine)
Open Label, 8 week cycle
Other Name: BAY86-5326
Experimental: Arm 1
Intervention: Drug: Sargramostim (Leukine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
378
December 2006
December 2006   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   New Zealand,   Russian Federation,   Switzerland,   Ukraine,   United Kingdom
 
NCT00206700
307340, 91274, Novel 5
Not Provided
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP