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

May 10, 2018 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)
Time Frame: Up to Week 24
Up to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR
Time Frame: Up to Week 24
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)
Time Frame: Up to Week 24
Up to Week 24
Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)
Time Frame: Up to week 24
Up to week 24
Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
Time Frame: Up to Week 24
Up to Week 24
Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
Time Frame: Up to Week 24
Up to Week 24
Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
Time Frame: Up to Week 24
Up to Week 24
Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
Time Frame: Up to Week 24
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)
Time Frame: Up to Week 24
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)
Time Frame: Up to Week 24
Up to Week 24
Change from baseline in total tender joint count (TJC)
Time Frame: Up to Week 24
Up to Week 24
Change from baseline in total swollen joint count (SJC)
Time Frame: Up to Week 24
Up to Week 24
Percentage of participants having TJC <=1
Time Frame: Up to Week 24
Up to Week 24
Percentage of participants having SJC <=1
Time Frame: Up to Week 24
Up to Week 24
Patient Global Assessment of disease activity visual analogue scale (VAS) score
Time Frame: Up to Week 24
Up to Week 24
Physician Global Assessment of disease activity VAS score
Time Frame: Up to Week 24
Up to Week 24
Percentage of participants having CRP <=1mg/dl
Time Frame: Up to Week 24
Up to Week 24
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: Up to Week 24
Up to Week 24
EQ-5D-5L Health Questionnaire (EuroQoL)
Time Frame: Up to Week 24
Up to Week 24
Morisky Medication-Taking Adherence Scale (MMAS)
Time Frame: Up to Week 24
Up to Week 24
Percentage of participants using TCZ in monotherapy
Time Frame: At baseline
At baseline
Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)
Time Frame: At baseline
At baseline
Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
nv Roche sa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML29691

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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