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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552940
• Other study ID #: ML29691
• Status: Completed
• Start date: October 31, 2015
• Est. completion date: October 23, 2017

Study information

• Verified date: May 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 23, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
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	AZ Sint Blasius (Dendermonde)	Dendermonde
Belgium	UZ Antwerpen	Edegem
Belgium	Reumacentrum Genk	Genk
Belgium	Reumaclinic	Genk
Belgium	GHdC Site Saint-Joseph	Gilly (Charleroi)
Belgium	AZ Groeninge	Kortrijk
Belgium	CHU Sart-Tilman	Liège
Belgium	Private Practice	Lokeren
Belgium	CHU UCL Mont-Godinne	Mont-godinne
Belgium	AZ Damiaan	Oostende
Belgium	AZ Oudenaarde	Oudenaarde
Belgium	AZ Alma vzw (Sijsele)	Sijsele
Belgium	AZ Sint Jozef Malle	Westmalle
Belgium	Sint Augustinus Wilrijk	Wilrijk
Belgium	CVBA Diagnosecentrum Voorkempen	Zoersel
Luxembourg	Höpital Kirchberg; Rheumatology	Luxembourg

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	nv Roche sa

Countries where clinical trial is conducted

Belgium,  Luxembourg, 

Outcome

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