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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03843125




Registration number
NCT03843125
Ethics application status
Date submitted
14/02/2019
Date registered
15/02/2019

Titles & IDs
Public title
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
Scientific 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)
Secondary ID [1] 0 0
I4V-MC-JAIM
Secondary ID [2] 0 0
16832
Universal Trial Number (UTN)
Trial acronym
SLE-BRAVE-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo

Experimental: 2 mg Baricitinib - Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).

Experimental: 4 mg Baricitinib - Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.

Experimental: Placebo to 2 mg Baricitinib - Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.

Experimental: Placebo to 4 mg Baricitinib - Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.


Treatment: Drugs: Baricitinib
Administered orally.

Treatment: Drugs: Placebo
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Week 134
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Timepoint [2] 0 0
Week 134
Primary outcome [3] 0 0
Percentage of Participants With Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Week 134
Primary outcome [4] 0 0
Percentage of Participants With Temporary Investigational Product Interruptions
Timepoint [4] 0 0
Week 134
Primary outcome [5] 0 0
Percentage of Participants With Permanent Investigational Product Discontinuations
Timepoint [5] 0 0
Week 134
Secondary outcome [1] 0 0
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
Timepoint [1] 0 0
Week 134
Secondary outcome [2] 0 0
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Change From Baseline in Prednisone Dose
Timepoint [3] 0 0
Baseline through Week 48
Secondary outcome [4] 0 0
Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate
Timepoint [4] 0 0
Baseline through Week 48
Secondary outcome [5] 0 0
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score =10 at Baseline With =50% Reduction in CLASI Total Activity Score
Timepoint [5] 0 0
Week 48
Secondary outcome [6] 0 0
Change From Baseline in Tender Joint Count
Timepoint [6] 0 0
Baseline through Week 48
Secondary outcome [7] 0 0
Change From Baseline in Swollen Joint Count
Timepoint [7] 0 0
Baseline trough Week 48
Secondary outcome [8] 0 0
Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score
Timepoint [8] 0 0
Baseline through Week 48
Secondary outcome [9] 0 0
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
Timepoint [9] 0 0
Baseline through Week 48

Eligibility
Key inclusion criteria
* Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2022
Sample size
Target
Accrual to date
Final
1147
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Optimus Clinical Research - Botany
Recruitment hospital [2] 0 0
The Rheumatology Research Unit Sunshine Coast - Maroochydore
Recruitment hospital [3] 0 0
Emeritus Research - Camberwell
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
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United States of America
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Alabama
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Sevilla
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Switzerland
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Sankt Gallen
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Dalin Township
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Kaohsiung
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Taipei
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Taiwan
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Taoyuan City
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United Kingdom
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Kent
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United Kingdom
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London
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United Kingdom
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Surrey
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United Kingdom
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Doncaster
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United Kingdom
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Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Incyte Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03843125