A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE

Hoffmann-La Roche22 sites in 2 countries140 target enrollmentOctober 31, 2015

ConditionsRheumatoid Arthritis

InterventionsTocilizumab

DrugsTocilizumab

Overview

Phase: Not Applicable
Intervention: Tocilizumab
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 140
Locations: 22
Primary Endpoint: Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 31, 2015

End Date

October 23, 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Rheumatoid Arthritis participants treated with Tocilizumab SC

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

Intervention: Tocilizumab

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

Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)(Up to Week 24)
Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)(Up to Week 24)
Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)(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)(Up to Week 24)
Change from baseline in total tender joint count (TJC)(Up to Week 24)
Physician Global Assessment of disease activity VAS score(Up to Week 24)
Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)(Up to Week 24)
Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)(Up to week 24)
Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)(Up to Week 24)
Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR(Up to Week 24)
Change from baseline in total swollen joint count (SJC)(Up to Week 24)
Percentage of participants having TJC <=1(Up to Week 24)
Patient Global Assessment of disease activity visual analogue scale (VAS) score(Up to Week 24)
Percentage of participants having CRP <=1mg/dl(Up to Week 24)
Health Assessment Questionnaire Disability Index (HAQ-DI)(Up to Week 24)
EQ-5D-5L Health Questionnaire (EuroQoL)(Up to Week 24)
Morisky Medication-Taking Adherence Scale (MMAS)(Up to Week 24)
Percentage of participants using TCZ in monotherapy(At baseline)
Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)(At baseline)
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)(Up to Week 24)
Percentage of participants having SJC <=1(Up to Week 24)
Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)(At baseline)