A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK) (SELECT-TAK)
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ClinicalTrials.gov Identifier: NCT04161898 |
Recruitment Status :
Recruiting
First Posted : November 13, 2019
Last Update Posted : November 28, 2022
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | November 12, 2019 | ||||||||||||||||
First Posted Date ICMJE | November 13, 2019 | ||||||||||||||||
Last Update Posted Date | November 28, 2022 | ||||||||||||||||
Actual Study Start Date ICMJE | February 4, 2020 | ||||||||||||||||
Estimated Primary Completion Date | April 23, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Time to First Relapse of Takayasu Arteritis (TAK) From Baseline [ Time Frame: Up to occurrence of 40 events (approximately 52 months) ] Relapse of TAK is defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms.
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Original Primary Outcome Measures ICMJE |
Time to First Relapse of Takayasu Arteritis (TAK) From Baseline [ Time Frame: Up to occurrence of 40 events (approximately 31 months) ] Relapse of TAK is defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms.
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK) | ||||||||||||||||
Official Title ICMJE | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-Takayasu) | ||||||||||||||||
Brief Summary | The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen. | ||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Takayasu Arteritis (TAK) | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||
* 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 | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
56 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | August 30, 2027 | ||||||||||||||||
Estimated Primary Completion Date | April 23, 2024 (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 | 15 Years and older (Child, Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Brazil, China, Japan, Korea, Republic of, Turkey | ||||||||||||||||
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Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04161898 | ||||||||||||||||
Other Study ID Numbers ICMJE | M19-052 | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | AbbVie | ||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||
Current Study Sponsor ICMJE | AbbVie | ||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | AbbVie | ||||||||||||||||
Verification Date | November 2022 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |