Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)

Sponsor
Hoffmann-La Roche
Study ID
NCT02402686
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.

Study Details

The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.

Key Dates

Start date
May 20, 2015
Status verified
Dec 2019
Primary completion
Dec 17, 2018
Completion
Dec 17, 2018

Study Design

Enrollment
353 participants (actual)

Arms

  • Arm: Tocilizumab for RA in Routine Clinical Practice
    Participants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation.

Primary Outcome Measure

Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study [ Time Frame: Baseline, end of study (up to 24 weeks) ]

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