A Study To Monitor Long-Term Treatment With PF-00547659 (OPERA II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01298492
First received: January 26, 2011
Last updated: February 25, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: PF-00547659
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Open-label Extension Study To Assess Long-term Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera Ii)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Frequency of on-treatment AEs, AEs leading to withdrawal, and SAEs. [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of the development of Anti-drug Antibodies [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Plasma trough concentrations of PF-00547659 will be analyzed using population Pharmacokinetic (PK) methodology. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: July 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-Label Treatment
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
75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298492

  Show 120 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01298492     History of Changes
Other Study ID Numbers: A7281007, 2010-024638-48, OPERA II
Study First Received: January 26, 2011
Last Updated: February 25, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Anti-TNF Refractory
Immunosuppressant Refractory
Active Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2015