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

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ClinicalTrials.gov Identifier: NCT01771809
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Drug: 75mg PF-00547659 Drug: 225mg PF-00547659 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
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)
Actual Study Start Date : March 1, 2013
Actual Primary Completion Date : December 13, 2017
Actual Study Completion Date : December 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




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

Secondary Outcome Measures :
  1. Frequency of the development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs). [ Time Frame: Week 72 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771809


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

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 )
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
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
Active Ulcerative Colitis
Immunosuppressant Refractory

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