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

NCT ID: NCT00329537

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Keywords

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Crohn's Disease Sargramostim CDAI Moderately to severely active Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Sargramostim (Leukine)

Intervention Type DRUG

Self-subcutaneous injection

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Self-subcutaneous injection

Interventions

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Sargramostim (Leukine)

Self-subcutaneous injection

Intervention Type DRUG

Placebo

Self-subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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BAY86-5326

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Countries

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Japan

Other Identifiers

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91510

Identifier Type: -

Identifier Source: secondary_id

309240

Identifier Type: -

Identifier Source: org_study_id