MedTrace Logo

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

NCT00206674 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2013-12-04

No results posted yet for this study

Summary

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

Conditions

  • Crohn Disease

Interventions

DRUG

Sargramostim (Leukine)

6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks

DRUG

Placebo

Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks

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
2004-09-30
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • Argentina
  • Australia
  • Brazil
  • Canada
  • New Zealand
  • Russia
  • Switzerland
  • Ukraine
  • United Kingdom

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 NCT00206674 on ClinicalTrials.gov