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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03773978
Ethics application status
Date submitted
11/12/2018
Date registered
12/12/2018
Date last updated
19/08/2019

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 Open-Label - Baricitinib given orally.

Experimental: Baricitinib Double Blind - Baricitinib given orally.

Placebo Comparator: Placebo Double Blind - Placebo given orally.


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 - Time to disease flare
Timepoint [1] 0 0
Week 12 to Week 44
Secondary outcome [1] 0 0
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 responder index (PedACR30) - Proportion of participants achieving PedACR30
Timepoint [1] 0 0
Week 12 to Week 44
Secondary outcome [2] 0 0
Proportion of Participants with Inactive Disease - Proportion of participants with inactive disease
Timepoint [2] 0 0
Week 12 to Week 44
Secondary outcome [3] 0 0
Proportion of Participants with Minimal Disease Activity - Proportion of participants with minimal disease activity
Timepoint [3] 0 0
Week 12 to Week 44
Secondary outcome [4] 0 0
Proportion of Participants in Remission - Proportion of participants in remission
Timepoint [4] 0 0
Week 24 to Week 44
Secondary outcome [5] 0 0
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 - Change from baseline in juvenile arthritis disease activity score
Timepoint [5] 0 0
Baseline, Week 44
Secondary outcome [6] 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 - Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item
Timepoint [6] 0 0
Baseline, Week 44
Secondary outcome [7] 0 0
Change from Baseline in Psoriasis Area and Severity Index (PASI) Score - Change from baseline in PASI score
Timepoint [7] 0 0
Baseline, Week 44
Secondary outcome [8] 0 0
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index - Change from baseline in SPARCC enthesitis index
Timepoint [8] 0 0
Baseline, Week 44
Secondary outcome [9] 0 0
Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA) - Change from baseline in JSpADA
Timepoint [9] 0 0
Baseline, Week 44
Secondary outcome [10] 0 0
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) - PK: Cmax, ss of Baricitnib
Timepoint [10] 0 0
Baseline through Week 44
Secondary outcome [11] 0 0
PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) - PK: AUC, ss of Baricitnib
Timepoint [11] 0 0
Baseline through Week 44
Secondary outcome [12] 0 0
Change from Baseline in Immunophenotyping (T Cells) - Change from baseline in immunophenotyping (T Cells)
Timepoint [12] 0 0
Baseline, Week 12
Secondary outcome [13] 0 0
Change of Immunoglobulin G (IgG) Titers - Change of immunoglobulin G (IgG) titers
Timepoint [13] 0 0
Pre-Vaccination to 12 Weeks Post-Vaccination
Secondary outcome [14] 0 0
Acceptability Assessment - Participants were evaluated for baricitinib acceptability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the ease of use of baricitinib: Very difficult (or hard), difficult (or hard), neither easy nor hard, easy, or very easy.
Timepoint [14] 0 0
Week 44
Secondary outcome [15] 0 0
Palatability Assessment - Participants were evaluated for baricitinib palatability using a 5-category questionnaire. Participants were asked to answer one of the following to describe the taste and smell of baricitinib: Disliked very much, disliked, neither liked nor disliked, liked, or like very much.
Timepoint [15] 0 0
Week 44

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
Gender
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
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,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
Tucuman
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
RS
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Brazil
State/province [12] 0 0
São Paulo
Country [13] 0 0
China
State/province [13] 0 0
Jiangsu
Country [14] 0 0
China
State/province [14] 0 0
Tianjin City
Country [15] 0 0
China
State/province [15] 0 0
Beijing
Country [16] 0 0
China
State/province [16] 0 0
Suzhou
Country [17] 0 0
Czechia
State/province [17] 0 0
Prague
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 5
Country [19] 0 0
Denmark
State/province [19] 0 0
København Ø
Country [20] 0 0
Denmark
State/province [20] 0 0
Århus N
Country [21] 0 0
France
State/province [21] 0 0
Bron
Country [22] 0 0
France
State/province [22] 0 0
Le Kremlin Bicetre
Country [23] 0 0
France
State/province [23] 0 0
Nimes Cedex 9
Country [24] 0 0
France
State/province [24] 0 0
Paris Cedex 15
Country [25] 0 0
France
State/province [25] 0 0
Poitiers
Country [26] 0 0
France
State/province [26] 0 0
Vandoeuvre les Nancy Cedex
Country [27] 0 0
Germany
State/province [27] 0 0
Baden-Württemberg
Country [28] 0 0
Germany
State/province [28] 0 0
Nordrhein-Westfalen
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
India
State/province [31] 0 0
Delhi
Country [32] 0 0
India
State/province [32] 0 0
Tamil Nadu
Country [33] 0 0
India
State/province [33] 0 0
Uttar Pradesh
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Kfar Saba
Country [36] 0 0
Israel
State/province [36] 0 0
Petah Tiqva
Country [37] 0 0
Israel
State/province [37] 0 0
Ramat Gan
Country [38] 0 0
Italy
State/province [38] 0 0
Ancona
Country [39] 0 0
Italy
State/province [39] 0 0
Brescia
Country [40] 0 0
Italy
State/province [40] 0 0
Chieti
Country [41] 0 0
Italy
State/province [41] 0 0
Firenze
Country [42] 0 0
Italy
State/province [42] 0 0
Genova
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Napoli
Country [45] 0 0
Italy
State/province [45] 0 0
Pisa
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Italy
State/province [47] 0 0
Trieste
Country [48] 0 0
Japan
State/province [48] 0 0
Ishikawa
Country [49] 0 0
Japan
State/province [49] 0 0
Kanagawa
Country [50] 0 0
Japan
State/province [50] 0 0
Miyagi
Country [51] 0 0
Japan
State/province [51] 0 0
Osaka
Country [52] 0 0
Japan
State/province [52] 0 0
Saitama
Country [53] 0 0
Japan
State/province [53] 0 0
Tokyo
Country [54] 0 0
Japan
State/province [54] 0 0
Kagoshima
Country [55] 0 0
Japan
State/province [55] 0 0
Niigata
Country [56] 0 0
Mexico
State/province [56] 0 0
Jalisco
Country [57] 0 0
Mexico
State/province [57] 0 0
Nuevo León
Country [58] 0 0
Mexico
State/province [58] 0 0
Yucatán
Country [59] 0 0
Mexico
State/province [59] 0 0
Chihuahua
Country [60] 0 0
Mexico
State/province [60] 0 0
Durango
Country [61] 0 0
Poland
State/province [61] 0 0
Krakow
Country [62] 0 0
Poland
State/province [62] 0 0
Lodz
Country [63] 0 0
Poland
State/province [63] 0 0
Warszawa
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Moscow
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Saint-Petersburg
Country [66] 0 0
Spain
State/province [66] 0 0
Cataluna
Country [67] 0 0
Spain
State/province [67] 0 0
La Coruña
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Turkey
State/province [70] 0 0
Istanbul
Country [71] 0 0
Turkey
State/province [71] 0 0
Izmir
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Greater London
Country [73] 0 0
United Kingdom
State/province [73] 0 0
London
Country [74] 0 0
United Kingdom
State/province [74] 0 0
South Yorkshire
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Bristol
Country [76] 0 0
United Kingdom
State/province [76] 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
The reason for this study is to see if the study drug baricitinib given orally is safe and
effective in participants with JIA from 2 years to less than 18 years old.
Trial website
https://clinicaltrials.gov/show/NCT03773978
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03773978