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

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

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Tocilizumab

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • ASZ Aalst
  • Assebroek, Belgium, 8310
    • AZ Sint Lucas Brugge
  • Brugge, Belgium, 8000
    • AZ Sint Jan
  • Bruxelles, Belgium, 1070
    • Hospital Erasme; Neurologie
  • Bruxelles, Belgium, 1050
    • HIS (Etterbeek Ixelles)
  • Bruxelles, Belgium, 1000
    • CHU St Pierre (César de Paepe)
  • Dendermonde, Belgium, 9200
    • AZ Sint Blasius (Dendermonde)
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Genk, Belgium, 3600
    • ReumaClinic
  • Genk, Belgium, 3600
    • Reumacentrum Genk
  • Gilly (Charleroi), Belgium, 6000
    • GHdC Site Saint-Joseph
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Lokeren, Belgium, 9160
    • Private Practice
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
  • Oostende, Belgium, 8400
    • AZ Damiaan
  • Oudenaarde, Belgium, 9700
    • AZ Oudenaarde
  • Sijsele, Belgium, 8340
    • AZ Alma vzw (Sijsele)
  • Westmalle, Belgium, 2390
    • AZ Sint Jozef Malle
  • Wilrijk, Belgium, 2610
    • Sint Augustinus Wilrijk
  • Zoersel, Belgium, 2980
    • CVBA Diagnosecentrum Voorkempen
• Luxembourg
  • Luxembourg, Luxembourg, 2540
    • Höpital Kirchberg; Rheumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participant with a diagnosis of moderate to severe RA defined as DAS28 more than or equal to (>=) 3.7, naïve to TCZ and in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Tocilizumab; Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.; Other Names: RoACTEMRA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0)	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
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 disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)	Up to Week 24
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 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
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 tender joint count (TJC)	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
Percentage of participants having SJC <=1	Up to Week 24
Patient Global Assessment of disease activity visual analogue scale (VAS) score	Up to Week 24
Physician Global Assessment of disease activity 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 using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)	At baseline
Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)	At baseline

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: nv Roche sa

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2015
• Primary Completion (Actual): October 23, 2017
• Study Completion (Actual): October 23, 2017

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML29691