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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523239-21-00 | EU Trial (CTIS) Number |
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This OLE study is designed to evaluate long-term safety, tolerability, and efficacy of filgotinib in patients with polyarticular or systemic juvenile idiopathic arthritis (pJIA-sJIA) who have completed the treatment period/prolonged treatment period of the parent studies and demonstrated clinical benefit defined as control of disease activity through improvement in signs and symptoms as per Investigator judgement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib | Experimental | Filgotinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Investigational product (IP) will be provided as commercially developed film-coated tablets or age-appropriate film-coated tablets for use in pediatric subjects aged at least 8 years and needs to be taken orally once daily (q.d.) at approximately the same time every morning (with or without food) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation at each visit throughout the duration of the study. | From baseline (Day 1) up to Week 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with JIA American College of Rheumatology (ACR) 30 response over time. | Week 1, Week 26, Week 52 and Week 78 | |
| Percentage of subjects with JIA ACR inactive disease. | Week 1, Week 26, Week 52 and Week 78 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Vincent | Contact | 00800 7878 1345 | medicalinfo@alfasigma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bicetre Hospital | Not yet recruiting | Le Kremlin-Bicêtre | 94270 | France |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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|
| Percentage of subjects with JIA ACR clinical remission over time. | Week 1, Week 26, Week 52 and Week 78 |
| Incidence of treatment-emergent uveitis (including severity). | Week 1, Week 26, Week 52, Week 78 |
| Hamburger Zentrum für Kinder- und Jugendrheumatologie | Recruiting | Hamburg | 22081 | Germany |
|
| Asklepios Klinik Sankt Augustin GmbH | Not yet recruiting | Sankt Augustin | 53757 | Germany |
|
| Great Ormond Street Hospital for Children | Not yet recruiting | London | WC1N 3JH | United Kingdom |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |