NCT02552940

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
2 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2017

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

September 16, 2015

Last Update Submit

May 10, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)

    Up to Week 24

Secondary Outcomes (22)

  • 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

  • +17 more secondary outcomes

Study Arms (1)

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

Interventions

TocilizumabDRUG

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

Also known as: RoACTEMRA
Rheumatoid Arthritis participants treated with Tocilizumab SC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

ASZ Aalst

Aalst, 9300, Belgium

Location

AZ Sint Lucas Brugge

Assebroek, 8310, Belgium

Location

AZ Sint Jan

Bruges, 8000, Belgium

Location

CHU St Pierre (César de Paepe)

Brussels, 1000, Belgium

Location

HIS (Etterbeek Ixelles)

Brussels, 1050, Belgium

Location

Hospital Erasme; Neurologie

Brussels, 1070, Belgium

Location

AZ Sint Blasius (Dendermonde)

Dendermonde, 9200, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

Reumacentrum Genk

Genk, 3600, Belgium

Location

Reumaclinic

Genk, 3600, Belgium

Location

GHdC Site Saint-Joseph

Gilly (Charleroi), 6000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

CHU Sart-Tilman

Liège, 4000, Belgium

Location

Private Practice

Lokeren, 9160, Belgium

Location

CHU UCL Mont-Godinne

Mont-godinne, 5530, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

AZ Oudenaarde

Oudenaarde, 9700, Belgium

Location

AZ Alma vzw (Sijsele)

Sijsele, 8340, Belgium

Location

AZ Sint Jozef Malle

Westmalle, 2390, Belgium

Location

Sint Augustinus Wilrijk

Wilrijk, 2610, Belgium

Location

CVBA Diagnosecentrum Voorkempen

Zoersel, 2980, Belgium

Location

Höpital Kirchberg; Rheumatology

Luxembourg, 2540, Luxembourg

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 17, 2015

Study Start

October 31, 2015

Primary Completion

October 23, 2017

Study Completion

October 23, 2017

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

LU(1)BE(21)