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B0151005 Open-Label Extension...

B0151005 Open-Label Extension Study

Last Updated: 2024-01-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-03-31

Brief Summary

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This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-label Treatment

Group Type EXPERIMENTAL

PF-04236921

Intervention Type BIOLOGICAL

Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.

PF-04236921

Intervention Type BIOLOGICAL

Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.

Interventions

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PF-04236921

Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.

Intervention Type BIOLOGICAL

PF-04236921

Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.

Exclusion Criteria

* Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
* Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Simon Medical Imaging

Scottsdale, Arizona, United States

Site Status

Digestive Health Research Unit

Scottsdale, Arizona, United States

Site Status

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Site Status

Adobe Surgery Center

Tucson, Arizona, United States

Site Status

Rocky Mountain Gastroenterology Associates

Lakewood, Colorado, United States

Site Status

Rocky Mountain Gastroenterology

Littleton, Colorado, United States

Site Status

Rocky Mountain Clinical Research, LLC.

Wheat Ridge, Colorado, United States

Site Status

Rocky Mountain Clinical Research, LLC

Wheat Ridge, Colorado, United States

Site Status

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Site Status

Gastroenterology Consultants of Clearwater

Clearwater, Florida, United States

Site Status

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status

Gastroenterology Associates

Crystal River, Florida, United States

Site Status

Nature Coast Clinical Research

Inverness, Florida, United States

Site Status

Suncoast Endoscopy Center

Inverness, Florida, United States

Site Status

International Clinical Research - US, LLC

Sanford, Florida, United States

Site Status

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, United States

Site Status

The Atlanta Center For Gastroenterology

Decatur, Georgia, United States

Site Status

Gastointestinal Specialists of Georgia, PC

Marietta, Georgia, United States

Site Status

Illinois Gastroenterology Group, LLC

Arlington Heights, Illinois, United States

Site Status

The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

NorthShore University Health System

Evanston, Illinois, United States

Site Status

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Site Status

U of L Health Care Outpatient Center

Louisville, Kentucky, United States

Site Status

University of Louisville Hospital

Louisville, Kentucky, United States

Site Status

Digestive Disorders Associates

Annapolis, Maryland, United States

Site Status

Drgestive Disorders Associates

Annapolis, Maryland, United States

Site Status

East Valley Endoscopy

Grand Rapids, Michigan, United States

Site Status

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, United States

Site Status

Metro Health Hospital Endoscopy Unit

Wyoming, Michigan, United States

Site Status

Metro Health Hospital

Wyoming, Michigan, United States

Site Status