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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Tocilizumab

• Registration Number: NCT02552940
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Study Start: 2015-10-31
• Primary Completion: 2017-10-23
• Study Completion: 2017-10-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis participants treated with Tocilizumab SC	Tocilizumab	Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.

Primary Outcome Measures

Name	Time	Method
Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
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
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
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
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 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
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

Trial Locations

Locations (22)

ASZ Aalst; 🇧🇪 Aalst, Belgium

Reumacentrum Genk; 🇧🇪 Genk, Belgium

AZ Damiaan; 🇧🇪 Oostende, Belgium

Private Practice; 🇧🇪 Lokeren, Belgium

Höpital Kirchberg; Rheumatology; 🇱🇺 Luxembourg, Luxembourg

UZ Antwerpen; 🇧🇪 Edegem, Belgium

Reumaclinic; 🇧🇪 Genk, Belgium

CHU Sart-Tilman; 🇧🇪 Liège, Belgium

AZ Sint Lucas Brugge; 🇧🇪 Assebroek, Belgium

AZ Sint Jan; 🇧🇪 Brugge, Belgium

CHU St Pierre (César de Paepe); 🇧🇪 Bruxelles, Belgium

HIS (Etterbeek Ixelles); 🇧🇪 Bruxelles, Belgium

Hospital Erasme; Neurologie; 🇧🇪 Bruxelles, Belgium

GHdC Site Saint-Joseph; 🇧🇪 Gilly (Charleroi), Belgium

AZ Alma vzw (Sijsele); 🇧🇪 Sijsele, Belgium

AZ Sint Jozef Malle; 🇧🇪 Westmalle, Belgium

CVBA Diagnosecentrum Voorkempen; 🇧🇪 Zoersel, Belgium

AZ Sint Blasius (Dendermonde); 🇧🇪 Dendermonde, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

Sint Augustinus Wilrijk; 🇧🇪 Wilrijk, Belgium

CHU UCL Mont-Godinne; 🇧🇪 Mont-godinne, Belgium

AZ Oudenaarde; 🇧🇪 Oudenaarde, Belgium