Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year
- Registration Number
- NCT02608112
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
- Participants at least 18 years old
- Participants with moderate to severe RA not previously treated with TCZ (Intravenous [IV] or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csDMARD)
- Participants taking part in a clinical trial on RA at the time of inclusion
- Participants with a contra-indication to TCZ SC therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Moderate to Severe RA Methotrexate 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. Participants with Moderate to Severe RA Tocilizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Were on TCZ SC for a Period of 12 Months Up to 12 Months
- Secondary Outcome Measures
Name Time Method 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 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 Swollen Joints Count Months 3, 6, 12, and 18 Percentage of Participants with Definitive Discontinuation of Treatment Up to 18 Months Disease Activity Score Based of 28 Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Months 3, 6, 12, and 18 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
Trial Locations
- Locations (70)
Hopital Jean Minjoz
🇫🇷Besancon, France
CH de Saint Quentin
🇫🇷Saint Quentin, France
Cabinet de Rhumatologie MSP de Beaublanc
🇫🇷Limoges, France
Hopital Sainte Marguerite; Rhumatologie
🇫🇷Marseille, France
Hopital Pellegrin; Rhumatologie
🇫🇷Bordeaux, France
Hopital Dupuytren; Rhumatologie
🇫🇷Limoges, France
Hopital Emile Roux; Rhumatologie
🇫🇷Le Puy En Velay, France
Cabinet
🇫🇷Poitiers, France
Ch De Laon; Medecine Interne
🇫🇷Laon, France
Cabinet Medical.
🇫🇷Haguenau, France
Hopital Edouard Herriot; Pavillon F Rhumatologie
🇫🇷Lyon, France
Cabinet medical.
🇫🇷Lille, France
Fondation Hopital Saint Joseph; Rhumatologie
🇫🇷Marseille, France
Cabinet medical; Rhumatologie
🇫🇷Joue Les Tours, France
CH de Juvisy sur Orge; Consult. externes
🇫🇷Juvisy sur Orge, France
GHI Le Raincy Montfermeil
🇫🇷Montfermeil, France
Ch Lyon Sud; Rhumato Secteur Jules Courmont
🇫🇷Pierre Benite, France
Hopital Trousseau; Rhumatologie
🇫🇷Chambray Les Tours, France
Hôpital Victor Provo
🇫🇷Roubaix, France
Maison de Santé; MSP
🇫🇷Nogent Le Rotrou, France
Hopital; Pole geriatrique
🇫🇷Villeneuve sur Lot, France
Hopital Instruction Armees Begin; Rhumatologie
🇫🇷St Mande, France
Hopital Purpan; Rhumatologie
🇫🇷Toulouse, France
Cabinet Medical
🇫🇷Valenciennes, France
Hopital La Source; Rhumatologie
🇫🇷La Source, France
Ch Louis Pasteur; Medecine B3
🇫🇷Le Coudray, France
CH de Bicêtre; Rhumatologie
🇫🇷Le Kremlin Bicetre, France
CH Annecy Genevois; Rhumatologie
🇫🇷Metz Tessy, France
Hopital B Roger Salengro; Rhumatologie
🇫🇷Lille, France
Cabinet medical; Cabinet medical
🇫🇷Montpellier, France
Hopital Lapeyronie; Immunologie Rhumatologie
🇫🇷Montpellier, France
Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen
🇫🇷Montpellier, France
Ch Des Pays De Morlaix; Medecine I
🇫🇷Morlaix, France
Hopital Pasteur; Rhumatologie
🇫🇷Nice Cedex 1, France
Ch Pitie Salpetriere; Rhumatologie
🇫🇷Paris, France
Centre Hopsitalier Saint Nazaire; Medecine Polyvalente
🇫🇷Saint Nazaire, France
Centre Hospitalier Saint Quentin
🇫🇷Saint Quentin, France
Centre Medico-Chirurgical de Touraine
🇫🇷St Cyr Sur Loire, France
Centre medical des coteaux; Rhumatologie
🇫🇷Saintes, France
Hopital Hautepierre; Rhumatologie
🇫🇷Strasbourg, France
Hopitaux du Leman site Thonon; Rhumatologie
🇫🇷Thonon Les Bains, France
Cabinet de Rhumatologie
🇫🇷Toulouse, France
Hopitaux De Brabois; Rhumatologie
🇫🇷Vandoeuvre-les-nancy, France
Hopital Nord; Rhumatologie
🇫🇷St Priest En Jarez, France
Ch De Belfort; Rhumatologie
🇫🇷Belfort, France
Infirmerie Protestante; Medecine interne Cancerologie
🇫🇷Caluire, France
Hopital La Cavale Blanche; Rhumatologie
🇫🇷Brest, France
Hopital Cote De Nacre; Rhumatologie
🇫🇷Caen, France
CH Jean Rougier; Rhumato Reed Fonctionnelle
🇫🇷Cahors, France
HIA PERCY; Medecine Interne
🇫🇷Clamart, France
Cabinet medical,Rhumatologie
🇫🇷Castelnaudary, France
Hopital Gabriel Montpied; Service de Rhumatologie
🇫🇷Clermont-ferrand, France
CH compiègne
🇫🇷Compiègne, France
Centre Hospitalier Alpes
🇫🇷Contamine Sur Arve, France
CH Sud Francilien; Rhumatologie
🇫🇷Corbeil Essonnes, France
Hopital Henri Mondor; Rhumatologie
🇫🇷Creteil, France
Ch Louis Pasteur; Rhumato Med Interne Neurologie
🇫🇷Dole, France
Ch De Douai; Medecine Polyvalente
🇫🇷Dechy, France
CH de Dax
🇫🇷Dax, France
Hopital Victor Jousselin; Rhumatologie 4EME Sud
🇫🇷Druex, France
Hopital Sud; Rhumatologie
🇫🇷Echirolles, France
Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie
🇫🇷Paris, France
Chu La Miletrie; Rhumatologie
🇫🇷Poitiers, France
Hopital Sud Anne de Bretagne; Rhumatologie
🇫🇷Rennes, France
Ch D Ardeche Meridionale; Medecine A2
🇫🇷Aubenas, France
Institut Calot Helio Marin; Rhumatologie
🇫🇷Berck, France
Hopital Pierre Nouveau;Medecine C Unite Rhumatologie
🇫🇷Cannes, France
Chu Sud Francilien; Rhumatologie
🇫🇷Corbeil-essones, France
Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
🇫🇷GAP, France
Ctre De Rhumato Lyon Presqu ile
🇫🇷Lyon, France