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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

268

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2011

Longer than P75 for phase_2

Geographic Reach

15 countries

112 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.1 years study duration

First Submitted

Initial submission to the registry

January 26, 2011

Completed

22 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed

4 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2016

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

August 31, 2017

Completed

Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

5.1 years

First QC Date

January 26, 2011

Results QC Date

July 26, 2017

Last Update Submit

May 11, 2021

Conditions

Crohn's Disease

Keywords

Active Crohn's diseaseAnti-TNF RefractoryImmunosuppressant Refractory

Outcome Measures

Primary Outcomes (1)

Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
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.
From start of study treatment up to Week 72 (Treatment Period)

Secondary Outcomes (2)

Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies
Baseline up to Week 96
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

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

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

Drug: PF-00547659

Interventions

PF-00547659DRUG

75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.

Open-Label Treatment

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shirelead

Study Sites (112)

UCSD Medical Center - Thorton Hospital

La Jolla, California, 92037, United States

Location

Community Clinical Trials

Orange, California, 92868, United States

Location

GastroDiagnostics

Orange, California, 92868, United States

Location

Clinical Research of the Rockies

Lafayette, Colorado, 80026, United States

Location

Rmga - Rmcr

Thornton, Colorado, 80229, United States

Location

Rocky Mountain Gastroenterology Associates

Thornton, Colorado, 80229, United States

Location

MGG Group Co., Inc.

Washington D.C., District of Columbia, 20006, United States

Location

Florida Center for Gastroenterology

Largo, Florida, 33777, United States

Location

Sylvester Comprehensive Cancer Center