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| ID | Type | Description | Link |
|---|---|---|---|
| 49028 | Other Identifier | HMA-EMA Catalogues |
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An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib | Participants will receive treatment for moderate to severe active RA with at least one dose of filgotinib in accordance with the product label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Tablets are administered in accordance with the product label |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Persistence Rate | Treatment persistence rate at 24 months, defined as the percentage of participants continuing to receive filgotinib for 24 months from treatment initiation. | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity: Percentage of Participants Achieving Disease Activity Score for 28 Joint Count Using C-Reactive Protein (DAS28[CRP]) ≤3.2 and/or Clinical Disease Activity Index (CDAI) ≤10 | Up to 24 months | |
| Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of participants aged ≥ 18 years with moderate to severe active RA receiving filgotinib who will be enrolled in France.
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| Name | Affiliation | Role |
|---|---|---|
| Alfasigma Study Director | Alfasigma S.p.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie site Nord | Amiens | 80054 | France | |||
| CHU de Amiens Picardie |
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| Up to 24 months |
| Number of Participants With Adverse Events and Serious Adverse Events | Up to 24 months |
| Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score | Up to 24 months |
| Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score | Up to 24 months |
| Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score | Up to 24 months |
| Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID) | Up to 24 months |
| Amiens |
| 80054 |
| France |
| Hopital Avicenne AP-HP | Bobigny | 93000 | France |
| CHU Bordeaux | Bordeaux | 33000 | France |
| CH de Cahors | Cahors | 46005 | France |
| Clinique de l'Infirmerie Protestante de Lyon | Caluire-et-Cuire | 69300 | France |
| Hopital Sud Francilien Corbeil Essonne | Corbeil-Essonnes | 91106 | France |
| Hopital Roger Salengro | Lille | 59037 | France |
| CHU de Nice | Nice | 06000 | France |
| Centre Hospitalier Régional d'Orléans | Orléans | 45100 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| Hopital Cochin Service A | Paris | 75014 | France |
| Hopital Robert Debre | Reims | 51092 | France |
| CHU de Rouen | Rouen | 76000 | France |
| Centre Hospitalier Universitaire de Saint Etienne | Saint-Etienne | 42000 | France |
| CHU Toulouse | Toulouse | 31000 | France |
| CHRU de Tours | Tours | 37044 | France |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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