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Completed

NCT Number: NCT00206674

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

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Buenos Aires F.D., Argentina

Loading trial locations.

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

  • 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

Treatment and study plan

Sargramostim (Leukine)

Drug

6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks

Other names: BAY86-5326

Placebo

Drug

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

Primary outcomes

  1. Induction of clinical response and/or remission as defined by decrease in CDAI score

    Time frame: After 8 weeks of treatment

Secondary outcomes

  1. Time and duration to response/remission

    Time frame: During the 8 weeks of treatment

  2. QoL (different methods)

    Time frame: During the whole study

  3. Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)

    Time frame: About 20 months

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
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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