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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAHW | Other Identifier | Eli Lilly and Company | |
| 2019-000119-10 | EudraCT Number |
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The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Participants ≥9 to <18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets. |
|
| Adalimumab | Active Comparator | Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing <30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Percentage of Responders for Baricitinib at Week 24 | Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye | Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye. Outcome data will be provided after the study is completed. | Baseline, Week 24 |
| Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable) |
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Inclusion Criteria:
Exclusion Criteria:
Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
Participants must not have any contraindications to adalimumab.
Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant.
Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
Participants must not have a current or recent (<4 weeks prior to baseline) infection.
Participants must not have a positive test for hepatitis B virus (HBV) at screening.
Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre | 94270 | France | |||
| Hôpital Universitaire Necker Enfants Malades |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34627340 | Derived | Ramanan AV, Guly CM, Keller SY, Schlichting DE, de Bono S, Liao R, Quartier P. Clinical effectiveness and safety of baricitinib for the treatment of juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis: study protocol for an open-label, adalimumab active-controlled phase 3 clinical trial (JUVE-BRIGHT). Trials. 2021 Oct 9;22(1):689. doi: 10.1186/s13063-021-05651-5. |
| Label | URL |
|---|---|
| A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Overall, 30 participants were enrolled in the study. One participant (in baricitinib arm) withdrew from the study before administration of the study drug. This study is conducted in 2 parts. Part A (24 weeks) and Part B (260 weeks). Participants assigned to baricitinib and completed the Part A as a responder continued receiving baricitinib until the end of study or discontinuation from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baricitinib | Participants ≥9 to <18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2023 | Jul 11, 2024 |
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| Adalimumab | Drug | Administered SC |
|
Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable). Outcome data will be provided after the study is completed. |
| Baseline, Week 24 |
| Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline | Response is defined according to the SUN criteria as a 2-step decrease in the level of anterior chamber cells in the most severely affected eye at baseline (or both eyes if the inflammation grade is the same in both eyes) and a 1-step decrease in the level of anterior chamber cells in the less severely affected eye at baseline. Outcome data will be provided after the study is completed. | Week 24 |
| Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test | Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test. Outcome data will be provided after the study is completed. | Baseline, Week 24 |
| Change From Baseline in Vitreous Haze | Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed. | Baseline, Week 24 |
| Change From Baseline in Grade of Flare in the Anterior Chamber | Change from Baseline in Grade of Flare in the Anterior Chamber. Outcome data will be provided after the study is completed. | Baseline, Week 24 |
| Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition) | Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition). Outcome data will be provided after the study is completed. | Week 24 |
| Time to Inactive Anterior Uveitis Disease (Using SUN Definition) | Time to Inactive Anterior Uveitis Disease (Using SUN Definition). Outcome data will be provided after the study is completed. | Baseline through Week 24 |
| Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day | Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day. Outcome data will be provided after the study is completed. | Week 24 |
| Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U) | PediACR30 Response Rate (For Participants with JIA-U). Outcome data will be provided after the study is completed. | Week 24 |
| Change From Baseline in Overall Uveitis-Related Disability | Change from Baseline in Overall Uveitis-Related Disability. Outcome data will be provided after the study is completed. | Baseline, Week 24 |
| Paris |
| 75015 |
| France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | 86021 | France |
| Asklepios Klinik Sankt Augustin | Sankt Augustin | North Rhine-Westphalia | 53757 | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Charité Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari | Hamburg | 22081 | Germany |
| Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| Azienda Ospedaliero Universitaria Meyer | Florence | 50100 | Italy |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Infantil Universitario Niño Jesús | Madrid | Madrid, Comunidad de | 28009 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Hospital Universitario La Fe de Valencia | Valencia | 46026 | Spain |
| Bristol Royal Hospital for Children | Bristol | Bristol, City of | BS2 8BJ | United Kingdom |
| Cambridge Clinical Research Facility | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Alder Hey Children's Hospital | Liverpool | England | L14 5AB | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire | SO16 0YD | United Kingdom |
| Great Ormond Street Hospital For Children NHS Foundation Trust | London | WC1N 3JH | United Kingdom |
| Sheffield Children's Hospital | Sheffield | S10 2TH | United Kingdom |
| FG001 | Adalimumab | Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing <30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg. |
| Received At Least 1 Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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|
| Part B |
|
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baricitinib | Participants ≥9 to <18 years of age were administered 4 mg baricitinib QD. Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets. |
| BG001 | Adalimumab | Participants received adalimumab administered SC once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing <30 kg, or 40 mg every 2 weeks for participants weighing ≥30 kg. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Percentage of Responders for Baricitinib at Week 24 | Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline. | All participants who received at least one dose of baricitinib in Part A. | Posted | Number | Percentage of participants | Week 24 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye | Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye. Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Baseline, Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable) | Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable). Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Baseline, Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline | Response is defined according to the SUN criteria as a 2-step decrease in the level of anterior chamber cells in the most severely affected eye at baseline (or both eyes if the inflammation grade is the same in both eyes) and a 1-step decrease in the level of anterior chamber cells in the less severely affected eye at baseline. Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test | Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test. Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Baseline, Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vitreous Haze | Change from Baseline in Vitreous Haze. Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Baseline, Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Grade of Flare in the Anterior Chamber | Change from Baseline in Grade of Flare in the Anterior Chamber. Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Baseline, Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition) | Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition). Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Time to Inactive Anterior Uveitis Disease (Using SUN Definition) | Time to Inactive Anterior Uveitis Disease (Using SUN Definition). Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Baseline through Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day | Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day. Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U) | PediACR30 Response Rate (For Participants with JIA-U). Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Week 24 | Participants | ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Overall Uveitis-Related Disability | Change from Baseline in Overall Uveitis-Related Disability. Outcome data will be provided after the study is completed. | Not Posted | Jul 2029 | Baseline, Week 24 | Participants |
Baseline Up To 55 Weeks
All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baricitinib | Participants ≥9 to <18 years of age were administered 4 mg baricitinib QD. Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets. | 0 | 24 | 2 | 24 | 16 | 24 |
| EG001 | Adalimumab | Participants received adalimumab administered SC once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing <30 kg, or 40 mg every 2 weeks for participants weighing ≥30 kg. | 0 | 5 | 1 | 5 | 4 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitis | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Illness | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Mean platelet volume decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Bone development abnormal | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2023 | Jul 11, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Germany |
|
| Italy |
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| Spain |
|
| United Kingdom |
|