Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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)
Query!
Secondary ID [1]
0
0
I4V-MC-JAHV
Query!
Secondary ID [2]
0
0
16276
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
JUVE-BASIS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time to Disease Flare
Query!
Assessment method [1]
0
0
A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]), the ESR measure is only used as an acute phase reactant in the core criteria.
Query!
Timepoint [1]
0
0
Week 12 to Week 44
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving PedACR30 Responder Index
Query!
Assessment method [1]
0
0
The PedACR30 response is defined as at least 30% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \>30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle visual analogue scale \[VAS\]), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Query!
Timepoint [1]
0
0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [2]
0
0
Percentage of Participants Achieving PedACR50 Responder Index
Query!
Assessment method [2]
0
0
The PedACR50 response is defined as at least 50% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \> 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Query!
Timepoint [2]
0
0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [3]
0
0
Percentage of Participants Achieving PedACR70 Responder Index
Query!
Assessment method [3]
0
0
The PedACR70 response is defined as at least 70% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \> 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Query!
Timepoint [3]
0
0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [4]
0
0
Percentage of Participants Achieving PedACR90 Responder Index
Query!
Assessment method [4]
0
0
The PedACR90 response is defined as at least 90% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \> 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Query!
Timepoint [4]
0
0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [5]
0
0
Percentage of Participants Achieving PedACR100 Responder Index
Query!
Assessment method [5]
0
0
The PedACR100 response is defined as at least 100% improvement from baseline in 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by \> 30%. The 6 core response variables included in the PedACR criteria are: Number of active joints (defined as a joint that is swollen or in the absence of swelling has loss of passive motion accompanied by either pain on motion or joint tenderness) in 73 joints, Number of joints with limited range of motion in 69 joints, Physician's Global Assessment of Disease Activity (21-circle VAS), Parent's Global Assessment of Patient's Overall Well-being, Physical function as assessed by the CHAQ and Acute-phase reactant (hsCRP and ESR). When PedACR response is analyzed as secondary endpoint, ESR measure is only used as acute-phase reactant in the core criteria.
Query!
Timepoint [5]
0
0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [6]
0
0
Percentage of Participants With Inactive Disease
Query!
Assessment method [6]
0
0
Inactive disease is defined as the presence of all of the following:
1. No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS) - 27 score,
2. No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator,
3. No active uveitis as assessed by the investigator,
4. Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA),
5. Physician's Global Assessment of Disease Activity indicating no active disease (Score ranges are 0 to 100 and best possible score on scale is 0) and
6. Duration of morning stiffness =15 minutes.
Query!
Timepoint [6]
0
0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Minimal Disease Activity
Query!
Assessment method [7]
0
0
Minimal disease activity is calculated based on the scores from the
1. Physician's Global Assessment of Disease Activity
2. Parent's Global Assessment of Well-Being and
3. the number of swollen joints. If the physician's global assessment of disease activity is =3.5 (score range: 0-100), the parent's global rating of patient's overall well-being is =2.5 (score range: 0-100), and the swollen joint count is =1 (score range: 0-73), then the participant reaches minimal disease activity. if not, minimal disease activity is not reached.
Query!
Timepoint [7]
0
0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Query!
Secondary outcome [8]
0
0
Percentage of Participants in Remission
Query!
Assessment method [8]
0
0
Remission is defined as inactive disease for at least 24 consecutive weeks. Inactive disease is defined as the presence of all of the following: 1) No joints with active arthritis based on Juvenile Arthritis Disease Activity Score (JADAS)-27 score, 2) No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to JIA as assessed by the investigator, 3) No active uveitis as assessed by the investigator, 4) Normal ESR or hsCRP (i.e., within normal limits in the local laboratory or, if elevated, not attributable to JIA), 5) Physician's Global Assessment of Disease Activity indicating no active disease (best possible score on scale \[0\]) and 6) Duration of morning stiffness =15 minutes.
Query!
Timepoint [8]
0
0
Week 28, 32, 36, 40 and 44
Query!
Secondary outcome [9]
0
0
Change From Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS-27) Score
Query!
Assessment method [9]
0
0
The JADAS-27 score is based on 4 components: 1) Physician's global assessment of disease activity on a 0-100 mm VAS, 2) Parent's global assessment of overall well-being on a 0-100 mm VAS, 3) normalized ESR and 4) number of joints (maximum of 27) with active arthritis (cervical spine, elbows, wrists, metacarpophalangeal joints \[from first to third\], proximal interphalangeal joints, hips, knees, and ankles). The scores for the each of the first 3 components range from 0 -10; the score for the final component ranges from 0-27. The overall JADAS-27 score is sum of the 4 components and it ranges from 0-57. A higher score indicates more disease activity. Least square (LS) mean was calculated using Analysis of covariance (ANCOVA) model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.
Query!
Timepoint [9]
0
0
Baseline, Week 44
Query!
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
Query!
Assessment method [10]
0
0
CHAQ assesses the health status and physical function of children with juvenile arthritis over the past week. The CHAQ consists of a Disability Index and a Discomfort Index. The disability index consisted of 30 items grouped into the following 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3 (0 = no difficulty; 1 = some difficulty; 2 = much difficulty and 3 = unable to do or not applicable). The scores of 8 domains were averaged to calculate the CHAQ-Disability Index total score. A higher score indicates worse physical function. The discomfort index consisted of Parent's Global Assessment of Well-Being and pain assessment due to illness. The intensity of pain is scored on a VAS scale ranging from 0-100 mm, with zero referring to "no pain" and 100 referring to "very severe pain". A higher score indicates a worse outcome.
Query!
Timepoint [10]
0
0
Baseline, Week 44
Query!
Secondary outcome [11]
0
0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Query!
Assessment method [11]
0
0
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk and legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.
Query!
Timepoint [11]
0
0
Baseline, Week 44
Query!
Secondary outcome [12]
0
0
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index
Query!
Assessment method [12]
0
0
The SPARCC enthesitis is an index used to measure the severity of enthesitis (sites at which tendons and ligaments attach to bones). The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.
Query!
Timepoint [12]
0
0
Baseline, Week 44
Query!
Secondary outcome [13]
0
0
Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index
Query!
Assessment method [13]
0
0
The JSpADA index is used to evaluate the disease activity of juvenile spondyloarthritis. The JSpADA index scores will be determined by following 8 components: active joint count, active enthesitis count, pain over the past week, CRP level related to juvenile spondyloarthritis activity, morning stiffness greater than 15 minutes, clinical sacroiliitis, uveitis and back mobility. All items are transformed to values of 0, 0.5, or 1, and the total score ranges from 0 to 8, where higher scores indicate more disease activity. LS mean was calculated using ANCOVA model which includes treatment, baseline, prior biologic JIA therapy, combined JIA category and predose exposure ESR category value as fixed factors.
Query!
Timepoint [13]
0
0
Baseline, Week 44
Query!
Secondary outcome [14]
0
0
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
Query!
Assessment method [14]
0
0
Maximum Plasma Baricitinib Concentration at Steady-State
Query!
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)
Query!
Secondary outcome [15]
0
0
PK: Area Under the Baricitinib Concentration-Time Curve During a Dosing Interval at Steady-State (AUCt,ss)
Query!
Assessment method [15]
0
0
Area under the concentration-time curve of Baricitinib during a dosing interval at steady state.
Query!
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)
Query!
Secondary outcome [16]
0
0
Change From Baseline in Immunoglobulin Levels
Query!
Assessment method [16]
0
0
Change from baseline in Serum Immunoglobulin A, Serum Immunoglobulin G and Serum Immunoglobulin M levels at week 12 are presented.
Query!
Timepoint [16]
0
0
Baseline, Week 12
Query!
Secondary outcome [17]
0
0
Number of Participants With Change of Immunoglobulin G (IgG) Titers
Query!
Assessment method [17]
0
0
Number of participants with change of IgG titers eligible for tetanus / diphtheria / acellular pertussis (tDaP) vaccine and pneumococcal conjugate are presented. Participants who were immunized with tDaP or pneumococcal conjugate vaccine had their IgG antibody titers to the antigens evaluated preimmunization and at 4 and 12 weeks postimmunization. A primary immune response was assessed in participants who had never received tDaP or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with \>= 2-fold increase from baseline in \>=6 pneumococcal serotypes at week 4 and 12 is presented. For tDaP vaccine, number of participants with \>= 4-fold increase from baseline in participants with baseline titer \>=0.1 IU/mL at week 4 and 12 is presented.
Query!
Timepoint [17]
0
0
Pre-Vaccination to 4 and 12 Weeks Post-Vaccination
Query!
Secondary outcome [18]
0
0
Number of Participants With Product Acceptability and Palatability Assessment
Query!
Assessment method [18]
0
0
The questionnaire for product acceptability and palatability assessed the participants ability to swallow the tablet, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? and Question 5) How easy was it for you (your child) to swallow the medicine today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
Query!
Timepoint [18]
0
0
Baseline and week 12
Query!
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).
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/12/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/01/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
220
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
The Sydney Children's Hospitals Network - Westmead
Query!
Recruitment hospital [2]
0
0
Royal Childrens Hospital Melbourne - Parkville
Query!
Recruitment hospital [3]
0
0
Perth Children's Hospital - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [3]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Santa Fe
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Tucumán
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
Buenos Aires
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Vorarlberg
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Wien
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Brussels-Capital
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
East Flanders
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Leuven
Query!
Country [9]
0
0
Brazil
Query!
State/province [9]
0
0
Minas Gerais
Query!
Country [10]
0
0
Brazil
Query!
State/province [10]
0
0
Sao Paulo
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
São Paulo
Query!
Country [12]
0
0
China
Query!
State/province [12]
0
0
Jiangsu
Query!
Country [13]
0
0
China
Query!
State/province [13]
0
0
Tianjin City
Query!
Country [14]
0
0
China
Query!
State/province [14]
0
0
Beijing
Query!
Country [15]
0
0
China
Query!
State/province [15]
0
0
Suzhou
Query!
Country [16]
0
0
Czechia
Query!
State/province [16]
0
0
Prague
Query!
Country [17]
0
0
Czechia
Query!
State/province [17]
0
0
Praha 5
Query!
Country [18]
0
0
Denmark
Query!
State/province [18]
0
0
København Ø
Query!
Country [19]
0
0
Denmark
Query!
State/province [19]
0
0
Århus N
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Bron
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Le Kremlin Bicetre
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Nîmes
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Paris Cedex 15
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Poitiers
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Baden-Württemberg
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Nordrhein-Westfalen
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Berlin
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Hamburg
Query!
Country [29]
0
0
India
Query!
State/province [29]
0
0
Chennai
Query!
Country [30]
0
0
India
Query!
State/province [30]
0
0
Delhi
Query!
Country [31]
0
0
India
Query!
State/province [31]
0
0
Tamil Nadu
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
Haifa
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Kfar Saba
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Petah Tiqva
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Ramat Gan
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Brescia
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Chieti
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Firenze
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Genova
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Milano
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Napoli
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Trieste
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Ishikawa
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Kanagawa
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Miyagi
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Osaka
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Saitama
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Tokyo
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Kagoshima
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Niigata
Query!
Country [51]
0
0
Mexico
Query!
State/province [51]
0
0
Federal District
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Jalisco
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Nuevo León
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Chihuahua
Query!
Country [55]
0
0
Mexico
Query!
State/province [55]
0
0
Durango
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Krakow
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Lodz
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Warszawa
Query!
Country [59]
0
0
Russian Federation
Query!
State/province [59]
0
0
Moscow
Query!
Country [60]
0
0
Russian Federation
Query!
State/province [60]
0
0
Saint Petersburg
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
Cataluna
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
La Coruña
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Madrid
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Valencia
Query!
Country [65]
0
0
Turkey
Query!
State/province [65]
0
0
Istanbul
Query!
Country [66]
0
0
Turkey
Query!
State/province [66]
0
0
Izmir
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Greater London
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
London
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
South Yorkshire
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Bristol
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Liverpool
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03773978
Query!
Trial related presentations / publications
Query!
Public notes
Query!
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
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.
Query!
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/78/NCT03773978/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/78/NCT03773978/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03773978