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

Phase 2

Completed

Conditions: Crohn's Disease

Interventions: Drug: PF-00547659

Registration Number: NCT01298492

Lead Sponsor: Shire

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 268

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Treatment	PF-00547659	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)	From start of study treatment up to Week 72 (Treatment Period)	AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies	Baseline up to Week 96	Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (\>=) 4.64 at at least one of the time points.
Serum Trough Concentrations of PF-00547659 Versus Time	Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96	Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.

Trial Locations

Locations (110): 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, 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
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UCSD Medical Center - Thorton Hospital
🇺🇸La Jolla, California, United States