Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
- Registration Number
- NCT00206674
- Lead Sponsor
- Genzyme, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Sargramostim (Leukine) - Arm 2 Placebo -
- Primary Outcome Measures
Name Time Method Induction of clinical response and/or remission as defined by decrease in CDAI score After 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method 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