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Completed

NCT Number: NCT00206596

Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease

The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • You must have active Crohn's disease at screening and been diagnosed with Crohn's disease within 6 months at screening.
  • You must have steroid dependent disease (receiving between 10-40 mgs/day prednisone therapy for greater than 3 months prior to screening and had at least one unsuccessful attempt to reduce cortico-steroids due to worsening of disease).
  • You must be able to give yourself an injection of study drug or have another person help you give the injection.
  • You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.

Exclusion criteria

  • You may not be taking medications not allowed on this study.
  • You may not have had GI surgery or bowel obstruction in the last 6 months.
  • You may not have ever taken this drug or drugs of similar type in the past.

Treatment and study plan

Sargramostim (Leukine)

Drug

Once daily via subcutaneous injection for up 22 weeks

Other names: BAY86-5326

Placebo

Drug

Once daily via subcutaneous injection for up 22 weeks

Primary outcomes

  1. Corticosteroid-free remission

    Time frame: At the end of the study treatment

Secondary outcomes

  1. Steroid-free remission or response to treatment as defined by the protocol

    Time frame: At the end of the study treatment

  2. Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)

    Time frame: At the end of the study treatment

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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