Trial Review

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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
Date last updated
7/10/2022

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
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.
Timepoint [1] 0 0
Week 12 to Week 44
Secondary outcome [1] 0 0
Percentage of Participants Achieving PedACR30 Responder Index
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Timepoint [7] 0 0
Week 16, 20, 24, 28, 32, 36, 40 and 44
Secondary outcome [8] 0 0
Percentage of Participants in Remission
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.
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
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.
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
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.
Timepoint [10] 0 0
Baseline, Week 44
Secondary outcome [11] 0 0
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
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.
Timepoint [11] 0 0
Baseline, Week 44
Secondary outcome [12] 0 0
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Index
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.
Timepoint [12] 0 0
Baseline, Week 44
Secondary outcome [13] 0 0
Change From Baseline in Juvenile Spondyloarthritis Disease Activity (JSpADA) Index
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.
Timepoint [13] 0 0
Baseline, Week 44
Secondary outcome [14] 0 0
Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss)
Assessment method [14] 0 0
Maximum Plasma Baricitinib Concentration at Steady-State
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)
Assessment method [15] 0 0
Area under the concentration-time curve of Baricitinib during a dosing interval at steady state.
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
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.
Timepoint [16] 0 0
Baseline, Week 12
Secondary outcome [17] 0 0
Number of Participants With Change of Immunoglobulin G (IgG) Titers
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.
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
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".
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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