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Trial record 1 of 1 for:    NCT01771809
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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
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
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 SHP647 (PF-00547659) Drug: 225mg SHP647 (PF-00547659) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 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 18, 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: SHP647 75 mg
Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Drug: 75mg SHP647 (PF-00547659)
75 mg sterile liquid injected subcutaneously every 4 weeks.

Experimental: SHP647 225 mg
Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Drug: 225mg SHP647 (PF-00547659)
225 mg sterile liquid injected subcutaneously every 4 weeks.




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From start of study drug administration up to 168 weeks ]
    An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.


Secondary Outcome Measures :
  1. Percentage of Participants With Mucosal Healing at Week 16 [ Time Frame: Week 16 ]
    Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment [PGA]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.

  2. Serum Trough Concentrations of SHP647 Versus Time [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156 ]
    Serum trough concentrations of SHP647 versus time was reported.

  3. Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) [ Time Frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156 ]
    The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64. The number of participants with positive ADA was reported.

  4. Number of Participants With Positive Neutralizing Antibodies (NAb) [ Time Frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156 ]
    The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64.



Information from the National Library of Medicine

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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


Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Shire Physician Shire
  Study Documents (Full-Text)

Documents provided by Shire:
Study Protocol  [PDF] November 14, 2016
Statistical Analysis Plan  [PDF] February 2, 2018


Additional Information:
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01771809    
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
Results First Posted: April 18, 2019
Last Update Posted: April 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers

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