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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03843125
Ethics application status
Date submitted
14/02/2019
Date registered
15/02/2019
Date last updated
5/08/2019

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

Experimental: Baricitinib High Dose - Baricitinib administered orally.

Experimental: Baricitinib Low Dose - Baricitinib administered orally.


Treatment: Drugs: Baricitinib
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) - Percentage of participants with TEAEs
Timepoint [1] 0 0
Baseline through Week 156
Primary outcome [2] 0 0
Percentage of Participants with Adverse Events of Special Interest (AESIs) - Percentage of Participants with AESIs
Timepoint [2] 0 0
Baseline through Week 156
Primary outcome [3] 0 0
Percentage of Participants with Serious Adverse Events (SAEs) - Percentage of participants with SAEs
Timepoint [3] 0 0
Baseline through Week 156
Primary outcome [4] 0 0
Percentage of Participants with Temporary Investigational Product Interruptions - Percentage of participants with temporary investigational product interruptions
Timepoint [4] 0 0
Baseline through Week 156
Primary outcome [5] 0 0
Percentage of Participants with Permanent Investigational Product Discontinuations - Percentage of participants with permanent investigational product discontinuations
Timepoint [5] 0 0
Baseline through Week 156
Secondary outcome [1] 0 0
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response - Percentage of participants achieving SRI-4 response
Timepoint [1] 0 0
Week 156
Secondary outcome [2] 0 0
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) - Percentage of participants achieving a LLDAS
Timepoint [2] 0 0
Week 156
Secondary outcome [3] 0 0
Change from Baseline in Prednisone Dose - Change from baseline in prednisone dose
Timepoint [3] 0 0
Baseline, Week 156
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 - Annualized SELENA-SLEDAI flare index flare rate
Timepoint [4] 0 0
Baseline through Week 156
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 - Percentage of participants with CLASI total activity score =10 at baseline with =50% reduction in CLASI total activity score
Timepoint [5] 0 0
Week 156
Secondary outcome [6] 0 0
Change from Baseline in Tender Joint Count - Change from baseline in tender joint count
Timepoint [6] 0 0
Baseline, Week 156
Secondary outcome [7] 0 0
Change from Baseline in Swollen Joint Count - Change from baseline in swollen joint count
Timepoint [7] 0 0
Baseline, Week 156
Secondary outcome [8] 0 0
Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score - Change from baseline in SLICC/ACR damage index total score
Timepoint [8] 0 0
Baseline, Week 156
Secondary outcome [9] 0 0
Change from Baseline in Worst Pain Numeric Rating Scale (NRS) - Change from baseline in worst pain NRS
Timepoint [9] 0 0
Baseline, Week 156

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
Gender
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Optimus Clinical Research - Kogarah
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
Monash Health - Clayton
Recruitment hospital [5] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment outside Australia
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Madrid
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Pontevedra
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Sevilla
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Switzerland
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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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Taichung
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Tainan City
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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
Country [206] 0 0
United Kingdom
State/province [206] 0 0
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
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).
Trial website
https://clinicaltrials.gov/show/NCT03843125
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
There may be multiples sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03843125