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Clinical trial

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (BRAVE II)

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Last updated:18th Oct 2020
Status: Active, not recruiting
Identifier: NCT03616964
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (BRAVE II)


The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Actual Study Start Date: August 2, 2018
Estimated Primary Completion Date: October 15, 2021
Estimated Study Completion Date: November 15, 2021

Arm:
- Experimental: Baricitinib High Dose
- Experimental: Baricitinib Low Dose
- Placebo Comparator: Placebo

Category Value
Study type(s) Interventional
Expected enrolment 750
Actual Study start date 02 August 2018
Estimated Study Completion Date 15 November 2021

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