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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 January 2024 |
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Main ID: |
NCT01345318 |
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Date of registration:
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28/04/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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B0151005 Open-Label Extension Study
ANDANTE II |
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Scientific title:
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A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii) |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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191 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01345318 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Belgium
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Brazil
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Canada
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Czech Republic
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Czechia
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Denmark
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France
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Germany
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Hungary
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Ireland
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Israel
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Italy
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New Zealand
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12
week) induction period.
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Women of childbearing potential, who have sexual intercourse with a non surgically
sterilized male partner, must agree and commit to the use highly effective methods of
birth control from signing of the ICD through 26 weeks after the Final Study
Evaluation or for 62 weeks from the last dose of investigational product for any
subject who terminates early from this study.
Exclusion Criteria:
- Subjects that have completed Day 84 (Week 12) of study B0151003, and 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 inclusion in this study.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate entry into this study.
- Received any prohibited treatment during study B0151003 that, in the opinion of the
investigator, compromised the safety or efficacy of this study.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Biological: PF-04236921
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Primary Outcome(s)
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Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
[Time Frame: Baseline up to Week 48]
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Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
[Time Frame: At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.]
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Secondary ID(s)
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B0151005
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2011-000722-30
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ANDANTE II
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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