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Study of Sargramostim in Moderately to Severely Active Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sargramostim (Leukine)
Placebo
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Sargramostim, CDAI, Moderately to severely active Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug Moderately to severely active Crohn's disease at time of screening (i.e., Crohn's disease activity index [CDAI] >220 and <475 points) Exclusion Criteria: Colostomy or ileostomy Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage GI surgery within 6 months prior to receiving the 1st dose of study drug Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    Outcomes

    Primary Outcome Measures

    CDAI [Crohn's Disease Active Index] improvements

    Secondary Outcome Measures

    PRO [Patient-reported outcome] variables (QOL [Quality of life]
    PGI-C [Patient global impression of change])

    Full Information

    First Posted
    May 23, 2006
    Last Updated
    December 2, 2013
    Sponsor
    Genzyme, a Sanofi Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00329537
    Brief Title
    Study of Sargramostim in Moderately to Severely Active Crohn's Disease
    Official Title
    Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Terminated
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genzyme, a Sanofi Company

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo, in patients with moderately to severely active Crohn's disease.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease
    Keywords
    Crohn's Disease, Sargramostim, CDAI, Moderately to severely active Crohn's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Title
    Arm 2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Sargramostim (Leukine)
    Other Intervention Name(s)
    BAY86-5326
    Intervention Description
    Self-subcutaneous injection
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Self-subcutaneous injection
    Primary Outcome Measure Information:
    Title
    CDAI [Crohn's Disease Active Index] improvements
    Time Frame
    Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w
    Secondary Outcome Measure Information:
    Title
    PRO [Patient-reported outcome] variables (QOL [Quality of life]
    Time Frame
    Baseline, 1w, 4w, 8w, 12w
    Title
    PGI-C [Patient global impression of change])
    Time Frame
    Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug Moderately to severely active Crohn's disease at time of screening (i.e., Crohn's disease activity index [CDAI] >220 and <475 points) Exclusion Criteria: Colostomy or ileostomy Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage GI surgery within 6 months prior to receiving the 1st dose of study drug Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Genzyme, a Sanofi Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Sargramostim in Moderately to Severely Active Crohn's Disease

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