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

Genzyme

Status and phase

Terminated

Phase 2

Conditions

Crohn Disease

Treatments

Drug: Sargramostim (Leukine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00206700

Novel 5

91274

307340

Details and patient eligibility

About

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.

Full 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.

Enrollment

378 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 150 points and less than or equal to 450 points) if completely withdrawn from CS use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to 7.5 mg daily within 2 treatment cycles, and have a CDAI score less than or equal to 450 points if not completely withdrawn from CS use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)