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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01771809
First received: January 8, 2013
Last updated: March 16, 2017
Last verified: March 2017
  Purpose
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

Condition Intervention Phase
Ulcerative Colitis Drug: 75mg PF-00547659 Drug: 225mg PF-00547659 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Shire:

Primary Outcome Measures:
  • Frequency of on-treatment Adverse Events (AEs), AEs leading to withdrawal, and Severe Adverse Events (SAEs). [ Time Frame: Week 144 ]

Secondary Outcome Measures:
  • Frequency of the development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs). [ Time Frame: Week 72 ]
  • 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 ]

Estimated Enrollment: 270
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-Label Treatment Period 1A
75mg PF-00547659 subcutaneously every 4 weeks for 72 weeks
Drug: 75mg PF-00547659
75 mg sterile liquid injected subcutaneously once monthly for 72 weeks in treatment period 1.
Experimental: Open-Label Treatment Period 1B
225mg PF-00547659 subcutaneously every 4 weeks for 72 weeks (Weeks 0-72)
Drug: 225mg PF-00547659
225 mg sterile liquid injected subcutaneously once monthly for 72 weeks in treatment period 1.
Experimental: Open-Label Treatment Period 2
75mg PF-00547659 subcutaneously every 4 weeks for 18 months (Weeks 76-144)
Drug: 75mg PF-00547659
75 mg sterile liquid injected subcutaneously once monthly for 72 weeks in treatment period 2.

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of 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

  Show 99 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire
  More Information

Additional Information:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01771809     History of Changes
Other Study ID Numbers: A7281010
2012-002031-28 ( EudraCT Number )
TURANDOT II ( Other Identifier: Alias Study Number )
Study First Received: January 8, 2013
Last Updated: March 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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

ClinicalTrials.gov processed this record on August 18, 2017