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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03773978




Registration number
NCT03773978
Ethics application status
Date submitted
11/12/2018
Date registered
12/12/2018

Titles & IDs
Public title
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)
Secondary ID [1] 0 0
I4V-MC-JAHV
Secondary ID [2] 0 0
16276
Universal Trial Number (UTN)
Trial acronym
JUVE-BASIS
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
Treatment: Drugs - Placebo

Experimental: Baricitinib - Baricitinib was administered QD (once daily) as a 4-mg oral tablet for adolescent participants (12 to \<18 years of age) and children =9 years of age; and 2 mg for children \<9 years of age. Participants \<6 years of age received an oral suspension. Participants =6 to \<12 years old had the option of receiving an oral suspension. Participants \>12 years old were supplied tablets. The oral suspension dose was administered as 4-mg, 2-mg, 1-mg, and 0.5-mg as needed.

Placebo comparator: Placebo - Placebo matched to baricitinib was administered to participants during the DBW period.


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
Time to Disease Flare
Timepoint [1] 0 0
Week 12 to Week 44
Secondary outcome [1] 0 0
Percentage of Participants Achieving PedACR30 Responder Index
Timepoint [1] 0 0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Secondary outcome [2] 0 0
Percentage of Participants Achieving PedACR50 Responder Index
Timepoint [2] 0 0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Secondary outcome [3] 0 0
Percentage of Participants Achieving PedACR70 Responder Index
Timepoint [3] 0 0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Secondary outcome [4] 0 0
Percentage of Participants Achieving PedACR90 Responder Index
Timepoint [4] 0 0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Secondary outcome [5] 0 0
Percentage of Participants Achieving PedACR100 Responder Index
Timepoint [5] 0 0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Secondary outcome [6] 0 0
Percentage of Participants With Inactive Disease
Timepoint [6] 0 0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Secondary outcome [7] 0 0
Percentage of Participants With Minimal Disease Activity
Timepoint [7] 0 0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Secondary outcome [8] 0 0
Percentage of Participants in Remission
Timepoint [8] 0 0
Week 28, 32, 36, 40 and 44
Secondary outcome [9] 0 0
Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score
Timepoint [9] 0 0
Baseline, Week 44
Secondary outcome [10] 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 [10] 0 0
Baseline, Week 44
Secondary outcome [11] 0 0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Timepoint [11] 0 0
Baseline, Week 44
Secondary outcome [12] 0 0
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index
Timepoint [12] 0 0
Baseline, Week 44
Secondary outcome [13] 0 0
Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index
Timepoint [13] 0 0
Baseline, Week 44
Secondary outcome [14] 0 0
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
Timepoint [14] 0 0
For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)
Secondary outcome [15] 0 0
PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCt,ss)
Timepoint [15] 0 0
For Safety/PK period: Day 1, Day 4, Day 14 (pre dose) and Day 14 (post dose). For OLLI period: Day 1, Day 14, Day 28, Day 56 and 84 (pre dose)
Secondary outcome [16] 0 0
Change From Baseline in Immunoglobulin Levels
Timepoint [16] 0 0
Baseline, Week 12
Secondary outcome [17] 0 0
Number of Participants With Change of Immunoglobulin G (IgG) Titers
Timepoint [17] 0 0
Pre-Vaccination to 4 and 12 Weeks Post-Vaccination
Secondary outcome [18] 0 0
Number of Participants With Product Acceptability and Palatability Assessment
Timepoint [18] 0 0
Baseline and week 12

Eligibility
Key inclusion criteria
* Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including JPsA).
* Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants must not have systemic JIA, with or without active systemic features.
* Participants must not have persistent oligoarticular arthritis.
* Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.

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 assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/01/2022
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
The Sydney Children's Hospitals Network - Westmead
Recruitment hospital [2] 0 0
Royal Childrens Hospital Melbourne - Parkville
Recruitment hospital [3] 0 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
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
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Austria
State/province [4] 0 0
Vorarlberg
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels-Capital
Country [7] 0 0
Belgium
State/province [7] 0 0
East Flanders
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Brazil
State/province [9] 0 0
Minas Gerais
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
Brazil
State/province [11] 0 0
São Paulo
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
China
State/province [13] 0 0
Tianjin City
Country [14] 0 0
China
State/province [14] 0 0
Beijing
Country [15] 0 0
China
State/province [15] 0 0
Suzhou
Country [16] 0 0
Czechia
State/province [16] 0 0
Prague
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 5
Country [18] 0 0
Denmark
State/province [18] 0 0
København Ø
Country [19] 0 0
Denmark
State/province [19] 0 0
Århus N
Country [20] 0 0
France
State/province [20] 0 0
Bron
Country [21] 0 0
France
State/province [21] 0 0
Le Kremlin Bicetre
Country [22] 0 0
France
State/province [22] 0 0
Nîmes
Country [23] 0 0
France
State/province [23] 0 0
Paris Cedex 15
Country [24] 0 0
France
State/province [24] 0 0
Poitiers
Country [25] 0 0
Germany
State/province [25] 0 0
Baden-Württemberg
Country [26] 0 0
Germany
State/province [26] 0 0
Nordrhein-Westfalen
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
India
State/province [29] 0 0
Chennai
Country [30] 0 0
India
State/province [30] 0 0
Delhi
Country [31] 0 0
India
State/province [31] 0 0
Tamil Nadu
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Israel
State/province [33] 0 0
Kfar Saba
Country [34] 0 0
Israel
State/province [34] 0 0
Petah Tiqva
Country [35] 0 0
Israel
State/province [35] 0 0
Ramat Gan
Country [36] 0 0
Italy
State/province [36] 0 0
Brescia
Country [37] 0 0
Italy
State/province [37] 0 0
Chieti
Country [38] 0 0
Italy
State/province [38] 0 0
Firenze
Country [39] 0 0
Italy
State/province [39] 0 0
Genova
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Napoli
Country [42] 0 0
Italy
State/province [42] 0 0
Trieste
Country [43] 0 0
Japan
State/province [43] 0 0
Ishikawa
Country [44] 0 0
Japan
State/province [44] 0 0
Kanagawa
Country [45] 0 0
Japan
State/province [45] 0 0
Miyagi
Country [46] 0 0
Japan
State/province [46] 0 0
Osaka
Country [47] 0 0
Japan
State/province [47] 0 0
Saitama
Country [48] 0 0
Japan
State/province [48] 0 0
Tokyo
Country [49] 0 0
Japan
State/province [49] 0 0
Kagoshima
Country [50] 0 0
Japan
State/province [50] 0 0
Niigata
Country [51] 0 0
Mexico
State/province [51] 0 0
Federal District
Country [52] 0 0
Mexico
State/province [52] 0 0
Jalisco
Country [53] 0 0
Mexico
State/province [53] 0 0
Nuevo León
Country [54] 0 0
Mexico
State/province [54] 0 0
Chihuahua
Country [55] 0 0
Mexico
State/province [55] 0 0
Durango
Country [56] 0 0
Poland
State/province [56] 0 0
Krakow
Country [57] 0 0
Poland
State/province [57] 0 0
Lodz
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Moscow
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Saint Petersburg
Country [61] 0 0
Spain
State/province [61] 0 0
Cataluna
Country [62] 0 0
Spain
State/province [62] 0 0
La Coruña
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Valencia
Country [65] 0 0
Turkey
State/province [65] 0 0
Istanbul
Country [66] 0 0
Turkey
State/province [66] 0 0
Izmir
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Greater London
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London
Country [69] 0 0
United Kingdom
State/province [69] 0 0
South Yorkshire
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Bristol
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Liverpool

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
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/NCT03773978