Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus (TULIP SLE LTE)
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ClinicalTrials.gov Identifier: NCT02794285 |
Recruitment Status :
Completed
First Posted : June 9, 2016
Last Update Posted : January 25, 2022
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Sponsor:
AstraZeneca
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
AstraZeneca
Tracking Information | |||||||
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First Submitted Date ICMJE | June 6, 2016 | ||||||
First Posted Date ICMJE | June 9, 2016 | ||||||
Last Update Posted Date | January 25, 2022 | ||||||
Actual Study Start Date ICMJE | June 30, 2016 | ||||||
Actual Primary Completion Date | December 21, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
To measure the long-term safety and tolerability of IV anifrolumab by measuring the rates of adverse events of special interest and serious adverse events [ Time Frame: Week 208 ] Rates of Adverse events of special interest and serious adverse events using incidence rates (ie number of events divided by person-time at risk)
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Original Primary Outcome Measures ICMJE |
To characterise the long-term safety and tolerability of IV anifrolumab [ Time Frame: Week 208 ] Rates of Adverse events of special interest and Serious Adverse Events
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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 | Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | ||||||
Official Title ICMJE | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus. | ||||||
Brief Summary | The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab. | ||||||
Detailed Description | This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled extension study to characterising the long term safety and tolerability of of an intravenous treatment regimen of anifrolumab versus placebo in subjects with moderately to severely active systemic lupus erythematosus who completed a Phase 3 study (D3461C00004 or D3461C00005) through the 52-week double-blind treatment period. | ||||||
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 | Active Systemic Lupus Erythematosus | ||||||
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 | Completed | ||||||
Actual Enrollment ICMJE |
559 | ||||||
Original Estimated Enrollment ICMJE |
575 | ||||||
Actual Study Completion Date ICMJE | December 21, 2021 | ||||||
Actual Primary Completion Date | December 21, 2021 (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 | 18 Years to 70 Years (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 | Argentina, Australia, Bulgaria, Canada, Chile, Colombia, France, Germany, Hungary, Israel, Japan, Korea, Republic of, Lithuania, Mexico, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States | ||||||
Removed Location Countries | Belgium, Brazil, Czech Republic, Czechia, Italy, New Zealand, Singapore | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02794285 | ||||||
Other Study ID Numbers ICMJE | D3461C00009 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | AstraZeneca | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | AstraZeneca | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | PRA Health Sciences | ||||||
Investigators ICMJE |
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PRS Account | AstraZeneca | ||||||
Verification Date | January 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |