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

Hoffmann-La Roche353 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

353

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria * Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label * Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate Exclusion Criteria: * Treatment with tocilizumab more than 8 weeks prior to enrollment * Failure to meet local tocilizumab label indication criteria * Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy * Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy * History of any other autoimmune or joint inflammatory disease

Locations (18)

National Institute of Rheumatology and Physiotherapy; 4Th Rheumatology Department

Budapest, Hungary

Budai Irgalmasrendi Kórház KHT. II. Reumatológia

Budapest, Hungary

Outcomes

Primary Outcomes

Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study

Time frame: Baseline, end of study (up to 24 weeks)

Secondary Outcomes

Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study

Time frame: Baseline, end of study (up to 24 weeks)

Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6

Time frame: Up to 24 weeks

Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8

Time frame: Up to 24 weeks

Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups

The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing disease-modifying antirheumatic drugs (DMARDs), 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.

Time frame: Baseline, end of study (up to 24 weeks)

Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6

The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.

Time frame: Up to 24 weeks

Number of Tocilizumab SC Injections per Participant During Observational Treatment Period

Time frame: Up to 24 weeks

Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations

Data from ClinicalTrials.gov

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