B0151005 Open-Label Extension Study (ANDANTE II)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01345318 |
Recruitment Status :
Completed
First Posted : May 2, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Tracking Information | ||||
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First Submitted Date ICMJE | April 28, 2011 | |||
First Posted Date ICMJE | May 2, 2011 | |||
Results First Submitted Date ICMJE | January 30, 2017 | |||
Results First Posted Date ICMJE | March 20, 2017 | |||
Last Update Posted Date | March 20, 2017 | |||
Study Start Date ICMJE | June 2011 | |||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
The frequency of on-treatment adverse events, withdrawals due to adverse events, and serious adverse events (SAEs) will be reported. [ Time Frame: 48 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | B0151005 Open-Label Extension Study | |||
Official Title ICMJE | A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii) | |||
Brief Summary | This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Crohn's Disease | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Open-label Treatment
Interventions:
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Publications * | Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
191 | |||
Original Estimated Enrollment ICMJE |
180 | |||
Actual Study Completion Date ICMJE | March 2016 | |||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, New Zealand, Switzerland, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01345318 | |||
Other Study ID Numbers ICMJE | B0151005 2011-000722-30 ( EudraCT Number ) ANDANTE II ( Other Identifier: Alias Study Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |