Long-Term Safety Of PF-00547659 In Ulcerative Colitis (TURANDOT II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01771809
First received: January 8, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 72 weeks of open-label treatment to evaluate the long-term safety of the drug.


Condition Intervention Phase
Ulcerative Colitis
Drug: PF-00547659
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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 Ulcerative Colitis (TURANDOT II)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Frequency of on-treatment Adverse Events (AEs), AEs leading to withdrawal, and Severe Adverse Events (SAEs). [ Time Frame: Week 72 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of the development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs). [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Serum trough concentrations of PF 00547659. [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-Label Treatment 75mg Drug: PF-00547659
75 mg sterile liquid injected subcutaneously once monthly for 72 weeks. Subjects may escalate to 225 mg one time.
Experimental: Open-Label Treatment 225mg Drug: PF-00547659
225 mg sterile liquid injected subcutaneously once monthly for 72 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects between 18 and 66 years of age (Or 76 years of age if previously enrolled in study A7281008).
  • Subjects previously enrolled in study A7281009 (NCT01620255) or A7281008 (NCT01387594) who have completed the 84 day (12 week) induction period.

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of study A7281008 or study A7281009 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 preclude entry or participation in this study.
  • Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).
  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: NCT01771809

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 129 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: NCT01771809     History of Changes
Other Study ID Numbers: A7281010
Study First Received: January 8, 2013
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Anti-TNF Refractory
Immunosuppressant Refractory
Active Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014