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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03773965




Registration number
NCT03773965
Ethics application status
Date submitted
11/12/2018
Date registered
12/12/2018

Titles & IDs
Public title
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Scientific title
A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)
Secondary ID [1] 0 0
I4V-MC-JAHX
Secondary ID [2] 0 0
16278
Universal Trial Number (UTN)
Trial acronym
JUVE-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

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

Experimental: Baricitinib - Baricitinib given orally.


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

Outcomes
Primary outcome [1] 0 0
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Timepoint [1] 0 0
Baseline through Week 264
Primary outcome [2] 0 0
Number of Participants with Permanent Investigational Product Discontinuations
Timepoint [2] 0 0
Baseline through Week 264
Secondary outcome [1] 0 0
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Timepoint [1] 0 0
Week 264
Secondary outcome [2] 0 0
Proportion of Participants who have Disease Flare
Timepoint [2] 0 0
Baseline through Week 264
Secondary outcome [3] 0 0
Proportion of Participants with Inactive Disease
Timepoint [3] 0 0
Week 264
Secondary outcome [4] 0 0
Proportion of Participants with Minimal Disease Activity
Timepoint [4] 0 0
Week 264
Secondary outcome [5] 0 0
Proportion of Participants in Remission
Timepoint [5] 0 0
Week 264
Secondary outcome [6] 0 0
Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
Timepoint [6] 0 0
Baseline, Week 264
Secondary outcome [7] 0 0
Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
Timepoint [7] 0 0
Baseline, Week 264
Secondary outcome [8] 0 0
Change from Baseline in Psoriasis Area and Severity Index (PASI)
Timepoint [8] 0 0
Baseline, Week 264
Secondary outcome [9] 0 0
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Timepoint [9] 0 0
Baseline, Week 264
Secondary outcome [10] 0 0
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
Timepoint [10] 0 0
Baseline, Week 264
Secondary outcome [11] 0 0
Change from Baseline in Immunoglobulin Levels
Timepoint [11] 0 0
Baseline, Week 264
Secondary outcome [12] 0 0
Change from Baseline in Immunophenotyping (T Cells)
Timepoint [12] 0 0
Baseline, Week 264
Secondary outcome [13] 0 0
Change of Immunoglobulin G (IgG) Titers
Timepoint [13] 0 0
Pre-Vaccination to 12 Weeks Post-Vaccination

Eligibility
Key inclusion criteria
* Participants must have completed a previous study of baricitinib for the treatment of JIA.
Minimum age
1 Year
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants must not have had a permanent discontinuation of baricitinib in the prior study.
* Participants must have not developed an allergy to baricitinib.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2031
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Royal Children's Hospital - Melbourne
Recruitment hospital [3] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3052 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Santa Fe
Country [2] 0 0
Argentina
State/province [2] 0 0
Tucumán
Country [3] 0 0
Austria
State/province [3] 0 0
Vorarlberg
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles-Capitale, Région De
Country [6] 0 0
Belgium
State/province [6] 0 0
Oost-Vlaanderen
Country [7] 0 0
Belgium
State/province [7] 0 0
Vlaams-Brabant
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio Grande Do Sul
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Chongqing
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
Czechia
State/province [13] 0 0
Brno-mesto
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha 5
Country [15] 0 0
Czechia
State/province [15] 0 0
Olomouc
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha 2
Country [17] 0 0
Denmark
State/province [17] 0 0
Hovedstaden
Country [18] 0 0
Denmark
State/province [18] 0 0
Midtjylland
Country [19] 0 0
France
State/province [19] 0 0
Gard
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Rhône-Alpes
Country [22] 0 0
France
State/province [22] 0 0
Vienne
Country [23] 0 0
Germany
State/province [23] 0 0
Baden-Württemberg
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein-Westfalen
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
India
State/province [27] 0 0
Delhi
Country [28] 0 0
India
State/province [28] 0 0
Tamil Nadu
Country [29] 0 0
Israel
State/province [29] 0 0
HaMerkaz
Country [30] 0 0
Israel
State/province [30] 0 0
?eifa
Country [31] 0 0
Italy
State/province [31] 0 0
Campania
Country [32] 0 0
Italy
State/province [32] 0 0
Liguria
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Italy
State/province [34] 0 0
Sicilia
Country [35] 0 0
Italy
State/province [35] 0 0
Brescia
Country [36] 0 0
Italy
State/province [36] 0 0
Chieti
Country [37] 0 0
Italy
State/province [37] 0 0
Trieste
Country [38] 0 0
Japan
State/province [38] 0 0
Ishikawa
Country [39] 0 0
Japan
State/province [39] 0 0
Kanagawa
Country [40] 0 0
Japan
State/province [40] 0 0
Miyagi
Country [41] 0 0
Japan
State/province [41] 0 0
Osaka
Country [42] 0 0
Japan
State/province [42] 0 0
Saitama
Country [43] 0 0
Japan
State/province [43] 0 0
Tokyo
Country [44] 0 0
Japan
State/province [44] 0 0
Chiba
Country [45] 0 0
Japan
State/province [45] 0 0
Kagoshima
Country [46] 0 0
Japan
State/province [46] 0 0
Niigata
Country [47] 0 0
Mexico
State/province [47] 0 0
Distrito Federal
Country [48] 0 0
Mexico
State/province [48] 0 0
Jalisco
Country [49] 0 0
Mexico
State/province [49] 0 0
Nuevo León
Country [50] 0 0
Mexico
State/province [50] 0 0
Chihuahua
Country [51] 0 0
Mexico
State/province [51] 0 0
Durango
Country [52] 0 0
Poland
State/province [52] 0 0
Mazowieckie
Country [53] 0 0
Poland
State/province [53] 0 0
Malopolskie
Country [54] 0 0
Poland
State/province [54] 0 0
Lódzkie
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Moskva
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona [Barcelona]
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid, Comunidad De
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Sevilla
Country [60] 0 0
Spain
State/province [60] 0 0
València
Country [61] 0 0
Turkey
State/province [61] 0 0
Istanbul
Country [62] 0 0
Turkey
State/province [62] 0 0
Izmir
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Bristol, City Of
Country [64] 0 0
United Kingdom
State/province [64] 0 0
England
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Greater London
Country [66] 0 0
United Kingdom
State/province [66] 0 0
London, City Of
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Oxfordshire
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

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
There may be multiple 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

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: http://www.clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03773965