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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 23, 2006

Last Updated Date

May 5, 2009

Start Date ^†

June 2006

Current Primary Outcome Measures ^†

CDAI [Crohn's disease active index] improvements [ Time Frame: Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00329537 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

PRO [Patient-reported outcome] variables (QOL [Quality of life] [ Time Frame: Baseline, 1w, 4w, 8w, 12w ]
PGI-C [Patient global impression of change]) [ Time Frame: Baseline, 1w, 2w, 4w, 6w, 8w, 10w, 12w ]

Original Secondary Outcome Measures ^†

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

Descriptive Information

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 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 Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)

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

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Crohn Disease

Intervention ^†

Drug: Leukine (Sargramostim, BAY86-5326)
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

May 2007

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00329537

Responsible Party

Head Clinical Pharmacology, Bayer Yakuhin Ltd.

Secondary IDs ^††

309240, A36774

Study Sponsor ^†

Bayer

Collaborators ^††

Investigators ^†

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.