Crohn Disease
Conditions
Keywords
Morbus Crohn, Sargramostim, Phase III, Placebo Controlled
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.
Interventions
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
DRUGPlacebo
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stable but active Crohn's disease at the time of screening * Must be able to self-inject or have another person who can help with the injection
Exclusion criteria
* Not have a colostomy or ileostomy * Not be taking prohibited medications as defined in the protocol * Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months * Not have ever taken this drug or drugs of similar type in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction of clinical response and/or remission as defined by decrease in CDAI score | After 8 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Time and duration to response/remission | During the 8 weeks of treatment |
| QoL (different methods) | During the whole study |
| Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.) | About 20 months |
Countries
Argentina, Australia, Brazil, Canada, New Zealand, Russia, Switzerland, Ukraine, United Kingdom
Outcome results
None listed