Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

Hoffmann-La Roche291 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

291

Conditions

Rheumatoid Arthritis

Interventions

MethotrexateDRUG

Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.

TocilizumabDRUG

Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * Participants taking part in a clinical trial on RA at the time of inclusion * Participants with a contra-indication to TCZ SC therapy

Locations (77)

Outcomes

Primary Outcomes

Percentage of Participants Who Were on TCZ SC for a Period of 12 Months

Time frame: Up to 12 Months

Secondary Outcomes

Disease Activity Score Based on 28 Joints Count and C-Reactive Protein (DAS28-CRP)

Time frame: Months 3, 6, 12, and 18

Simple Disease Activity Index (SDAI)

Time frame: Months 3, 6, 12, and 18

Clinical Disease Activity Index (CDAI)

Time frame: Months 3, 6, 12, and 18

Percentage of Participants With EUropean League Against Rheumatism (EULAR) Response

Time frame: Months 3, 6, 12, and 18

Percentage of Participants Who Were on TCZ SC for a Period of 6 Months

Time frame: Up to 6 Months

Percentage of Participants Who Were on TCZ SC for a Period of 18 Months

Time frame: 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

Time frame: Up to 18 Months

Dose of Concomitant Steroids After Introduction of TCZ SC

Time frame: 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

Time frame: Months 6, 12, and 18

Data from ClinicalTrials.gov

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Hopital Nord; Rhumatologie

Amiens, 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

Besançon, 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-et-Cuire, France

...and 67 more locations