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

Genzyme

Status and phase: Completed; Phase 3

Conditions: Crohn Disease

Treatments: Drug: Placebo; Drug: Sargramostim (Leukine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206674

Novel 4

308380

91405

Details and patient eligibility

About

The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with 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: 286 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Sargramostim (Leukine)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo