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

Crohn Disease Clinical Trial

Official title:

Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206674
• Other study ID #: 308380
• Secondary ID: 91405Novel 4
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 2, 2013
• Start date: September 2004
• Est. completion date: June 2006

Study information

• Verified date: December 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00185497

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Sargramostim (Leukine)
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
• Placebo
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Canada,  New Zealand,  Russian Federation,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction of clinical response and/or remission as defined by decrease in CDAI score		After 8 weeks of treatment	No
Secondary	Time and duration to response/remission		During the 8 weeks of treatment	No
Secondary	QoL (different methods)		During the whole study	No
Secondary	Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)		About 20 months	Yes

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