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This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Moderate to Severe RA | Participants with moderate or severe RA, naïve to TCZ treatment (IV or SC), and who have no contra-indication to TCZ SC therapy as per the local label are included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were on TCZ SC for a Period of 12 Months | Up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP) | Months 3, 6, 12, and 18 | |
| Simple Disease Activity Index (SDAI) | Months 3, 6, 12, and 18 | |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with moderate to severe RA not previously treated with TCZ (IV or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another csDMARD.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Nord; Rhumatologie | Amiens | 80054 | France | |||
| Ch D Ardeche Meridionale; Medecine A2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33216287 | Derived | Hilliquin P, Barnetche T, Baillet A, Flipo RM, Lespessailles E, Roux C, Fardellone P, Gilbert-Marceau A, Idier I, Constantin A, Shipley E, Baudens G, Saraux A. Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study. Rheumatol Ther. 2021 Mar;8(1):95-108. doi: 10.1007/s40744-020-00253-0. Epub 2020 Nov 20. |
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| Tocilizumab | Drug | Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling. |
|
| Clinical Disease Activity Index (CDAI) |
| Months 3, 6, 12, and 18 |
| Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response | Months 3, 6, 12, and 18 |
| Percentage of Participants Who Were on TCZ SC for a Period of 6 Months | Up to 6 Months |
| Percentage of Participants Who Were on TCZ SC for a Period of 18 Months | Up to 18 Months |
| Percentage of Participants who were on TCZ SC at 6, 12 and 18 Months Among 2 Subgroups: Participants Administered TCZ SC as Monotherapy and Participants Administered TCZ SC with Methotrexate or csDMARD | Up to 18 Months |
| Dose of Concomitant Steroids After Introduction of TCZ SC | Months 6, 12, and 18 |
| Number of Participants with Adherence to TCZ SC Using the Compliance Questionnaire of Rheumatology 5 (CQR5) and Participants Diary Data | Months 6, 12, and 18 |
| Percentage of Participants with Definitive Discontinuation of Treatment | Up to 18 Months |
| Percentage of Participants Performing All Visits at Hospital/Office Based Rheumatologist | Up to 18 Months |
| Percentage of Participants Taking Sick Leaves or Getting Hospitalized Due to RA | Up to 18 Months |
| Tender Joints Count | Months 3, 6, 12, and 18 |
| Swollen Joints Count | Months 3, 6, 12, and 18 |
| Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | Months 3, 6, 12, and 18 |
| Aubenas |
| 07205 |
| France |
| Ch De Belfort; Rhumatologie | Belfort | 90016 | France |
| Institut Calot Helio Marin; Rhumatologie | Berck | 62608 | France |
| Hopital Jean Minjoz | Besançon | 25030 | France |
| Hopital Pellegrin; Rhumatologie | Bordeaux | 33076 | France |
| Hopital La Cavale Blanche; Rhumatologie | Brest | 29609 | France |
| Hopital Cote De Nacre; Rhumatologie | Caen | 14033 | France |
| CH Jean Rougier; Rhumato Reed Fonctionnelle | Cahors | 46005 | France |
| Infirmerie Protestante; Medecine interne Cancerologie | Caluire-et-Cuire | 69300 | France |
| Hopital Pierre Nouveau;Medecine C Unite Rhumatologie | Cannes | 06401 | France |
| Cabinet medical,Rhumatologie | Castelnaudary | 11400 | France |
| Hopital Trousseau; Rhumatologie | Chambray-lès-Tours | 37171 | France |
| HIA PERCY; Medecine Interne | Clamart | 92141 | France |
| Hopital Gabriel Montpied; Service de Rhumatologie | Clermont-Ferrand | 63003 | France |
| CH compiègne | Compiègne | 60200 | France |
| Centre Hospitalier Alpes | Contamine-sur-Arve | 74130 | France |
| Chu Sud Francilien; Rhumatologie | Corbeil-essones | 91106 | France |
| CH Sud Francilien; Rhumatologie | Corbeil-Essonnes | 91106 | France |
| Hopital Henri Mondor; Rhumatologie | Créteil | 94010 | France |
| CH de Dax | Dax | 40107 | France |
| Ch De Douai; Medecine Polyvalente | Dechy | 59187 | France |
| Ch Louis Pasteur; Rhumato Med Interne Neurologie | Dole | 39108 | France |
| Hopital Victor Jousselin; Rhumatologie 4EME Sud | Druex | 28102 | France |
| Hopital Sud; Rhumatologie | Échirolles | 38434 | France |
| Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente | Gap | 05000 | France |
| Cabinet Medical. | Haguenau | 67500 | France |
| Cabinet Medical | Haguenau | 67500 | France |
| Cabinet medical; Rhumatologie | Joué-lès-Tours | 37300 | France |
| CH de Juvisy sur Orge; Consult. externes | Juvisy-sur-Orge | 91265 | France |
| Cabinet | La Madeleine | 59110 | France |
| Hopital La Source; Rhumatologie | La Source | 45100 | France |
| Ch De Laon; Medecine Interne | Laon | 02001 | France |
| Ch Louis Pasteur; Medecine B3 | Le Coudray | 28630 | France |
| CH de Bicêtre; Rhumatologie | Le Kremlin-Bicêtre | 94275 | France |
| Hopital Emile Roux; Rhumatologie | Le Puy-en-Velay | 43012 | France |
| Hopital B Roger Salengro; Rhumatologie | Lille | 59037 | France |
| Cabinet medical. | Lille | 59800 | France |
| Hopital Dupuytren; Rhumatologie | Limoges | 87042 | France |
| Cabinet de Rhumatologie MSP de Beaublanc | Limoges | 87100 | France |
| Ctre De Rhumato Lyon Presqu ile | Lyon | 69002 | France |
| Hopital Edouard Herriot; Pavillon F Rhumatologie | Lyon | 69437 | France |
| Hopital Sainte Marguerite; Rhumatologie | Marseille | 13274 | France |
| Fondation Hopital Saint Joseph; Rhumatologie | Marseille | 13285 | France |
| CH Annecy Genevois; Rhumatologie | Metz-Tessy | 74370 | France |
| GHI Le Raincy Montfermeil | Montfermeil | 93370 | France |
| Cabinet medical; Cabinet medical | Montpellier | 34000 | France |
| Cabinet Medical | Montpellier | 34070 | France |
| Hopital Lapeyronie; Immunologie Rhumatologie | Montpellier | 34295 | France |
| Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen | Montpellier | 34295 | France |
| Ch Des Pays De Morlaix; Medecine I | Morlaix | 29672 | France |
| Cabinet Medical | Nice | 06000 | France |
| Hopital Pasteur; Rhumatologie | Nice | 06002 | France |
| Maison de Santé; MSP | Nogent-le-Rotrou | 28400 | France |
| Ch Pitie Salpetriere; Rhumatologie | Paris | 75651 | France |
| Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie | Paris | 75960 | France |
| Ch Lyon Sud; Rhumato Secteur Jules Courmont | Pierre-Bénite | 69495 | France |
| Cabinet | Poitiers | 86000 | France |
| Chu La Miletrie; Rhumatologie | Poitiers | 86021 | France |
| Hopital Sud Anne de Bretagne; Rhumatologie | Rennes | 35203 | France |
| Hôpital Victor Provo | Roubaix | 59056 | France |
| Centre Medico-Chirurgical de Touraine | Saint-Cyr-sur-Loire | 37540 | France |
| Cabinet Medical | Saint-Lô | 50000 | France |
| Hopital Instruction Armees Begin; Rhumatologie | Saint-Mandé | 94163 | France |
| Centre Hopsitalier Saint Nazaire; Medecine Polyvalente | Saint-Nazaire | 44606 | France |
| Hopital Nord; Rhumatologie | Saint-Priest-en-Jarez | 42277 | France |
| Centre Hospitalier Saint Quentin | Saint-Quentin | 02321 | France |
| CH de Saint Quentin | Saint-Quentin | 2100 | France |
| Centre medical des coteaux; Rhumatologie | Saintes | 17100 | France |
| Hopital Hautepierre; Rhumatologie | Strasbourg | 67098 | France |
| Hopitaux du Leman site Thonon; Rhumatologie | Thonon-les-Bains | 74203 | France |
| Cabinet de Rhumatologie | Toulouse | 31000 | France |
| Hopital Purpan; Rhumatologie | Toulouse | 31059 | France |
| Cabinet Medical | Tours | 37000 | France |
| Cabinet Medical | Valenciennes | 59300 | France |
| Hopitaux De Brabois; Rhumatologie | Vandœuvre-lès-Nancy | 54511 | France |
| Hopital; Pole geriatrique | Villeneuve-sur-Lot | 47305 | 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 |
|---|---|
| D008727 | Methotrexate |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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