A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (SLE-BRAVE-X)
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (SLE-BRAVE-X)
The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
Actual Study Start Date: September 9, 2019
Estimated Primary Completion Date: May 30, 2025
Estimated Study Completion Date: June 30, 2025
Arms:
- Experimental: Baricitinib High Dose
- Experimental: Baricitinib Low Dose
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 1100 |
| Actual Study start date | 09 September 2019 |
| Estimated Study Completion Date | 30 June 2025 |