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 Percentage of Participants with Definitive Discontinuation of Treatment Up to 18 Months 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 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 Nord; Rhumatologie
🇫🇷St Priest En Jarez, France
Ch D Ardeche Meridionale; Medecine A2
🇫🇷Aubenas, France
Ch De Belfort; Rhumatologie
🇫🇷Belfort, France
Institut Calot Helio Marin; Rhumatologie
🇫🇷Berck, France
Hopital Jean Minjoz
🇫🇷Besancon, France
Hopital Pellegrin; Rhumatologie
🇫🇷Bordeaux, France
Hopital La Cavale Blanche; Rhumatologie
🇫🇷Brest, France
Hopital Cote De Nacre; Rhumatologie
🇫🇷Caen, France
CH Jean Rougier; Rhumato Reed Fonctionnelle
🇫🇷Cahors, France
Infirmerie Protestante; Medecine interne Cancerologie
🇫🇷Caluire, France
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