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

NCT ID: NCT02552940

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-23

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Tocilizumab

Intervention Type DRUG

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

Interventions

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Tocilizumab

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

Intervention Type DRUG

Other Intervention Names

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RoACTEMRA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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nv Roche sa

UNKNOWN

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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ASZ Aalst

Aalst, , Belgium

Site Status

AZ Sint Lucas Brugge

Assebroek, , Belgium

Site Status

AZ Sint Jan

Bruges, , Belgium

Site Status

CHU St Pierre (César de Paepe)

Brussels, , Belgium

Site Status

HIS (Etterbeek Ixelles)

Brussels, , Belgium

Site Status

Hospital Erasme; Neurologie

Brussels, , Belgium

Site Status

AZ Sint Blasius (Dendermonde)

Dendermonde, , Belgium

Site Status

UZ Antwerpen

Edegem, , Belgium

Site Status

Reumacentrum Genk

Genk, , Belgium

Site Status

Reumaclinic

Genk, , Belgium

Site Status

GHdC Site Saint-Joseph

Gilly (Charleroi), , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

CHU Sart-Tilman

Liège, , Belgium

Site Status

Private Practice

Lokeren, , Belgium

Site Status

CHU UCL Mont-Godinne

Mont-godinne, , Belgium

Site Status

AZ Damiaan

Ostend, , Belgium

Site Status

AZ Oudenaarde

Oudenaarde, , Belgium

Site Status

AZ Alma vzw (Sijsele)

Sijsele, , Belgium

Site Status

AZ Sint Jozef Malle

Westmalle, , Belgium

Site Status

Sint Augustinus Wilrijk

Wilrijk, , Belgium

Site Status

CVBA Diagnosecentrum Voorkempen

Zoersel, , Belgium

Site Status

Höpital Kirchberg; Rheumatology

Luxembourg, , Luxembourg

Site Status

Countries

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Belgium Luxembourg

Other Identifiers

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ML29691

Identifier Type: -

Identifier Source: org_study_id

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