An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice

Hoffmann-La Roche140 enrolled

Overview

This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabDRUG

Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior to the enrolment visit can be included * Participants in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria Exclusion Criteria: * Participants who have received TCZ \>8 weeks prior to the enrolment visit * Participants who have previously received TCZ SC * Participants who have received treatment with any investigational agent within 4 weeks before starting treatment with TCZ SC

Locations (22)

ASZ Aalst

Aalst, Belgium

AZ Sint Lucas Brugge

Assebroek, Belgium

Outcomes

Primary Outcomes

Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)

Time frame: Up to Week 24

Secondary Outcomes

Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR

Time frame: Up to Week 24

Percentage of participants to achieve low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0)

Time frame: Up to Week 24

Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)

Time frame: Up to week 24

Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)

Time frame: Up to Week 24

Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)

Time frame: Up to Week 24

Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)

Time frame: Up to Week 24

Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)

Time frame: Up to Week 24

Percentage of participants to achieve a major and minor improvement in CDAl (more than or equal to [>=]13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)

Time frame: Up to Week 24

Data from ClinicalTrials.gov

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