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Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim

NCT00206713 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2013-12-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.

Conditions

  • Crohn Disease

Interventions

DRUG

Sargramostim (Leukine)

6 μg/kg sargramostim administered SC once daily for 8 weeks

DRUG

Placebo

Placebo administered SC once daily during the randomized retreatment phase.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00206713 on ClinicalTrials.gov