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

December 2, 2013 updated by: Genzyme, a Sanofi Company

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1118AAT
      • Buenos Aires, Capital Federal, Argentina, C1264AAA
  • Australia
      • Penrith, Australia, 2751
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Concord, New South Wales, Australia, 2139
      • New Lambton Heights, New South Wales, Australia, 2305
      • Sydney, New South Wales, Australia, 2050
      • Sydney, New South Wales, Australia, 2200
    • Queensland
      • Brisbane, Queensland, Australia, 4029
      • Brisbane, Queensland, Australia, 4101
    • South Australia
      • Adelaide, South Australia, Australia, 5043
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
    • Victoria
      • Ballarat, Victoria, Australia, 3350
      • Frankston, Victoria, Australia, 3199
      • Melbourne, Victoria, Australia, 3128
      • Melbourne, Victoria, Australia, 3065
      • Parkville, Victoria, Australia, 3050
      • Prahran, Victoria, Australia, 3181
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40110060
    • Parana
      • Curitiba, Parana, Brazil, 80060-900
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21949 900
    • RS
      • Porto Alegre, RS, Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-900
      • São Paulo, SP, Brazil, 05651-901
  • Canada
      • Quebec, Canada, G1S 4L8
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
      • Edmonton, Alberta, Canada, T5H 4B9
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
      • Vancouver, British Columbia, Canada, V5Z 1H2
      • Vancouver, British Columbia, Canada, V6Z 2K5
      • Victoria, British Columbia, Canada, V8R 6T9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
      • London, Ontario, Canada, N6A 5A5
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M3N 2V7
      • Windsor, Ontario, Canada, N9A 1L9
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
      • Montreal, Quebec, Canada, H3T 1E2
      • Montreal, Quebec, Canada, H3G 1A4
      • Sherbrooke, Quebec, Canada, J1G 2E9
  • New Zealand
      • Christchurch, New Zealand, 8011
      • Hamilton, New Zealand, 3204
    • Auckland
      • Milford, Auckland, New Zealand, 1309
  • Russian Federation
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 123154
      • Moskva, Russian Federation, 127015
      • Volgograd, Russian Federation, 400107
    • Russia
      • Lipetsk, Russia, Russian Federation, 398055
      • Moskva, Russia, Russian Federation, 105203
      • Samara, Russia, Russian Federation, 443023
  • Switzerland
      • Basel, Switzerland, 4031
      • Bern, Switzerland, 3010
    • Waadt
      • Lausanne, Waadt, Switzerland, 1011
  • Ukraine
      • Donetsk, Ukraine, 83017
      • Kharkiv, Ukraine, 61001
      • Kiev, Ukraine, 03049
      • Lviv, Ukraine, 49044
      • Vinnitsa, Ukraine, 26014
  • United Kingdom
      • London, United Kingdom, WC1E 6AU
      • Sheffield, United Kingdom, S10 2JF
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8HW
    • Greater London
      • London, Greater London, United Kingdom, W12 0HS
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH4 2XU
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XW
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Sargramostim (Leukine)
6µg/kg SARGRAMOSTIM subcutaneous daily for 8 weeks
Other Names:
  • BAY86-5326
Placebo Comparator: Arm 2
Drug: Placebo
Sterile liquid solution, inactive excipient only subcutaneous daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Induction of clinical response and/or remission as defined by decrease in CDAI score
Time Frame: After 8 weeks of treatment
After 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Time and duration to response/remission
Time Frame: During the 8 weeks of treatment
During the 8 weeks of treatment
QoL (different methods)
Time Frame: During the whole study
During the whole study
Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)
Time Frame: About 20 months
About 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308380
  • 91405
  • Novel 4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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