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

Use our guide to learn which trials are right for you!

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
sites
324
mi
from 43215
Chevy Chase, MD
Click here to add this to my saved trials
Orlando, Florida 32806
796
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
2006
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
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...
515
mi
from 43215
Albany, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27514
350
mi
from 43215
Chapel Hill, NC
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
344
mi
from 43215
Chapel Hill, NC
Click here to add this to my saved trials
Chapel Hill, North Carolina 27517
353
mi
from 43215
Chapel Hill, NC
Click here to add this to my saved trials
Chapell Hill, North Carolina 27599
354
mi
from 43215
Chapell Hill, NC
Click here to add this to my saved trials
Clive, Iowa 50325
573
mi
from 43215
Clive, IA
Click here to add this to my saved trials
573
mi
from 43215
Clive, IA
Click here to add this to my saved trials
573
mi
from 43215
Clive, IA
Click here to add this to my saved trials
Columbia, Missouri 65201
501
mi
from 43215
Columbia, MO
Click here to add this to my saved trials
Flushing, New York 11355
487
mi
from 43215
Flushing, NY
Click here to add this to my saved trials
492
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
491
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
Great Neck, New York 11021
492
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
Great Neck, New York 11021
492
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
Hillsborough, North Carolina 27278
343
mi
from 43215
Hillsborough, NC
Click here to add this to my saved trials
La Jolla, California 92307
1899
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
LaFayette, Colorado 80026
1165
mi
from 43215
LaFayette, CO
Click here to add this to my saved trials
832
mi
from 43215
Largo, FL
Click here to add this to my saved trials
474
mi
from 43215
Mexico, MO
Click here to add this to my saved trials
Mexico, Missouri 65265
474
mi
from 43215
Mexico, MO
Click here to add this to my saved trials
992
mi
from 43215
Miami, FL
Click here to add this to my saved trials
992
mi
from 43215
Miami, FL
Click here to add this to my saved trials
992
mi
from 43215
Miami, FL
Click here to add this to my saved trials
992
mi
from 43215
Miami, FL
Click here to add this to my saved trials
1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
University of Miami Hospital The University of Miami changed the face of modern health care...
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
New York, New York 10075
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
New York, New York 11230
442
mi
from 43215
New York, NY
Click here to add this to my saved trials
Orange, California 92868
1959
mi
from 43215
Orange, CA
Click here to add this to my saved trials
Orange, California 92868
1959
mi
from 43215
Orange, CA
Click here to add this to my saved trials
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...
490
mi
from 43215
Poughkeepsie, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63110
397
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63110
397
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
397
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
St. Louis, Missouri 63108
397
mi
from 43215
St. Louis, MO
Click here to add this to my saved trials
1159
mi
from 43215
Thornton, CO
Click here to add this to my saved trials
Thornton, Colorado 80229
1159
mi
from 43215
Thornton, CO
Click here to add this to my saved trials
Troy, Michigan 48098
182
mi
from 43215
Troy, MI
Click here to add this to my saved trials
Troy, Michigan 48098
181
mi
from 43215
Troy, MI
Click here to add this to my saved trials
Washington, District of Columbia 20006
327
mi
from 43215
Washington,
Click here to add this to my saved trials
Wauwatosa, Wisconsin 53226
334
mi
from 43215
Wauwatosa, WI
Click here to add this to my saved trials
4607
mi
from 43215
Wien,
Click here to add this to my saved trials
Worcester, Massachusetts 01605
605
mi
from 43215
Worcester, MA
Click here to add this to my saved trials
Worcester, Massachusetts 01655
604
mi
from 43215
Worcester, MA
Click here to add this to my saved trials