A Study To Monitor Long-Term Treatment With PF-00547659



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:6/2/2016
Start Date:July 2011
End Date:July 2016

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A Multicenter Open-label Extension Study To Assess Long-term Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera Ii)

This study provides open-label drug to eligible patients who have completed a prior study of
PF-00547659. The primary endpoint for this study is long-term safety.

The rationale for conducting this open-label extension (OLE) study is primarily to evaluate
long term safety of PF 00547659. This protocol also provides the opportunity for continued
treatment for subjects responding to treatment from the feeder study. It also provides an
opportunity for initial treatment for subjects randomized to placebo in the feeder study.
This is a multi center Phase 2, open label, safety extension study for feeder studies which
evaluate PF 00546759 in subjects with moderate to severe Crohn's disease. Subjects eligible
for this study will have completed the 12 week double blind induction period in study
A7281006 and will be stratified by responders or non responders based on change in CDAI in
that study, without unblinding treatment assignment from study A7281006. Additionally,
subjects who have completed study A7281008 with a clinical response, as defined by that
protocol, will also be eligible for this study and treated as "responders". All subjects
entering this study must have discontinued immunosuppressant therapy.

Subjects entering this study will be given a 75 mg SC dose at baseline and then every 4
weeks through Week 72. After the active treatment period, the subjects will enter a 24 month
follow up period including 6 monthly visits followed by 18 month extended contact (every 6
month telephone contacts). At Week 96, subjects will undergo an End of Study visit but will
continue the every 6 month telephone contacts until Week 168.

Inclusion Criteria:

- Subjects between 18 and 76 years of age.

- Subjects previously enrolled in study A7281006 who have completed the blinded 84 day
(12 week) induction period or in study A7281008 who have completed Week 12 and have
demonstrated a clinical response as defined by that protocol.

Exclusion Criteria:

- Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have
experienced serious event(s) related to the investigational product, an unstable
medical condition, or any other reason, in the opinion of the investigator, would
hinder entry or participation in this study.

- Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.
We found this trial at
47
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Flushing, New York 11355
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Orlando, Florida 32806
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Chapel Hill, North Carolina 27514
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Chapel Hill, North Carolina 27599
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Chapel Hill, North Carolina 27517
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Chapell Hill, North Carolina 27599
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Clive, Iowa 50325
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Columbia, Missouri 65201
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Great Neck, New York 11021
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Great Neck, New York 11021
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Hillsborough, North Carolina 27278
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La Jolla, California 92307
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LaFayette, Colorado 80026
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Mexico, Missouri 65265
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
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New York, New York 10075
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New York, New York 11230
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Orange, California 92868
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Orange, California 92868
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63110
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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St. Louis, Missouri 63108
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Thornton, Colorado 80229
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Troy, Michigan 48098
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Washington, District of Columbia 20006
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Wauwatosa, Wisconsin 53226
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Worcester, Massachusetts 01605
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Worcester, Massachusetts 01655
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