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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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
UCSD Medical Center - Thorton Hospital
La Jolla, California, United States
Community Clinical Trials
Orange, California, United States
GastroDiagnostics
Orange, California, United States
Clinical Research of the Rockies
Lafayette, Colorado, United States
Rmga - Rmcr
Thornton, Colorado, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, United States
MGG Group Co., Inc.
Washington D.C., District of Columbia, United States
Florida Center for Gastroenterology
Largo, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Miami Crohn's and Colitis Center
Miami, Florida, United States
Start Date
July 1, 2011
Primary Completion Date
July 27, 2016
Completion Date
July 27, 2016
Last Updated
June 3, 2021
268
ACTUAL participants
PF-00547659
DRUG
Lead Sponsor
Shire
NCT06226883
NCT07184931
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06918808