Clinical trial NCT02552940: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: nv Roche sa
First posted: 2015-09-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)
timeFrame: Up to Week 24
Secondary outcomes:
measure: Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR
timeFrame: Up to Week 24
measure: 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)
timeFrame: Up to Week 24
measure: Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)
timeFrame: Up to week 24
measure: Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
timeFrame: Up to Week 24
measure: Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
timeFrame: Up to Week 24
measure: Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
timeFrame: Up to Week 24
measure: Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
timeFrame: Up to Week 24
measure: 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)
timeFrame: Up to Week 24
measure: Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)
timeFrame: Up to Week 24
measure: Change from baseline in total tender joint count (TJC)
timeFrame: Up to Week 24
measure: Change from baseline in total swollen joint count (SJC)
timeFrame: Up to Week 24
measure: Percentage of participants having TJC <=1
timeFrame: Up to Week 24
measure: Percentage of participants having SJC <=1
timeFrame: Up to Week 24
measure: Patient Global Assessment of disease activity visual analogue scale (VAS) score
timeFrame: Up to Week 24
measure: Physician Global Assessment of disease activity VAS score
timeFrame: Up to Week 24
measure: Percentage of participants having CRP <=1mg/dl
timeFrame: Up to Week 24
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Up to Week 24
measure: EQ-5D-5L Health Questionnaire (EuroQoL)
timeFrame: Up to Week 24
measure: Morisky Medication-Taking Adherence Scale (MMAS)
timeFrame: Up to Week 24
measure: Percentage of participants using TCZ in monotherapy
timeFrame: At baseline
measure: Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)
timeFrame: At baseline
measure: Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)
timeFrame: At baseline
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Assebroek
country: Belgium
facility: AZ Sint Lucas Brugge
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Bruxelles
country: Belgium
facility: CHU St Pierre (César de Paepe)
city: Bruxelles
country: Belgium
facility: HIS (Etterbeek Ixelles)
city: Bruxelles
country: Belgium
facility: Hospital Erasme; Neurologie
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius (Dendermonde)
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Genk
country: Belgium
facility: Reumacentrum Genk
city: Genk
country: Belgium
facility: Reumaclinic
city: Gilly (Charleroi)
country: Belgium
facility: GHdC Site Saint-Joseph
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Lokeren
country: Belgium
facility: Private Practice
city: Mont-godinne
country: Belgium
facility: CHU UCL Mont-Godinne
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Oudenaarde
country: Belgium
facility: AZ Oudenaarde
city: Sijsele
country: Belgium
facility: AZ Alma vzw (Sijsele)
city: Westmalle
country: Belgium
facility: AZ Sint Jozef Malle
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Zoersel
country: Belgium
facility: CVBA Diagnosecentrum Voorkempen
city: Luxembourg
country: Luxembourg
facility: Höpital Kirchberg; Rheumatology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: