EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis

March 22, 2019 updated by: Hoffmann-La Roche

Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.

The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.

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 (Anticipated)

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.
200

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

  • Greece
      • Agrinio, Greece, 301 00
        • Private Practice Rheumatology, Merantzis
      • Athens, Greece, 11521
        • Rheumatology Private Practice
      • Athens, Greece, 14527
        • General Hospital of Athens KAT, Rheumatology
      • Athens, Greece
        • Rheumatology Private Practice
      • Chania, Greece, 731 00
        • Rheumatology Private Practice
      • Drama, Greece, 66132
        • Private Practice Rheumatology, Papadimitriou
      • Eleusina, Greece, 19200
        • Rheumatology Private Practice
      • Haidari, Greece, 124 62
        • ATTIKO Hospital_4th University Internal Medicine Clinic
      • Ioannina, Greece, 453 33
        • Private Practice Rheumatology, Georgiadis
      • Kalithea, Athens, Greece, 17673
        • Rheumatology Private Practice
      • Karditsa, Greece, 431 00
        • Private Practice Rheumatology, Kotrotsios
      • Kavala, Greece, 65500
        • General Hospital of Kavala; Rheumatology
      • Kifisia, Greece
        • Rheumatology Private Practice
      • Larisa, Greece, 412 21
        • Private Practice Rehumatology, Ziogas
      • Mytilini, Greece, 811 00
        • General Hospital of Mytilini, Rheumatology
      • Nea Smyrni, Greece, 171 21
        • Private Practice Rheumatology, Trontzas
      • Patissia, Greece
        • Private Practice Rheumatology, Stavropoulos
      • Patra, Greece, 26221
        • Rheumatology Private Practice
      • Patras, Greece, 26443
        • Olympion Medical Center of Patras, Internal Medicine Clinic
      • Serres, Greece, 621 22
        • Private Practice Rheumatology, Psaltis
      • Serres, Greece, 62122
        • Rheumatology Private Practice
      • Thessaloniki, Greece, 54621
        • Rheumatology Private Practice
      • Thessaloniki, Greece
        • General Hospital Agios Pavlos
      • Thessaloniki, Greece
        • Rheumatology Private Practice
      • Veroia, Greece, 59100
        • Rheumatology Private Practice
      • Volos, Greece, 38221
        • Rheumatology Private Practice

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

Participants with rheumatoid arthritis for whom the physician has made the decision to start subcutaneous Tocilizumab treatment.

Description

Inclusion Criteria:

- Aged >/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment.

Exclusion Criteria:

  • Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to enrolment.
  • Participants who have received TCZ in past treatments.
  • Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment TCZ SC.
  • Participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (RA).

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.
Subcutaneous Tocilizumab
Participants receiving treatment for rheumatoid arthritis (RA) with subcutaneous Tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) according to approved label.
Biological: Tocilizumab
Subcutaneous Tocilizumab according to approved label.
Other Names:
  • ACTEMRA

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
Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation
Time Frame: At 52 weeks
At 52 weeks

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
Health Assessment Questionnaire (HAQ) Score
Time Frame: At baseline, 24 and 52 weeks
At baseline, 24 and 52 weeks
Visual Analog Scale (VAS) Pain Score in a 100 mm Scale
Time Frame: At baseline, 24 and 52 weeks
At baseline, 24 and 52 weeks
Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale
Time Frame: At baseline, 24 and 52 weeks
At baseline, 24 and 52 weeks
Percentage of Participants with Clinically Significant Changes in Laboratory Values
Time Frame: At baseline, 24 and 52 weeks
At baseline, 24 and 52 weeks
Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy
Time Frame: At baseline, 24 and 52 weeks
At baseline, 24 and 52 weeks
Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)
Time Frame: At baseline, 24 and 52 weeks
At baseline, 24 and 52 weeks
Percentage of Participants with Adverse Events (AEs), including Serious Adverse Events (SAEs), Non-Serious Adverse Drug Reactions (nsADRs), Injection Site Reactions (ISRs), and Adverse Events of Special Interest (AESIs)
Time Frame: Up to 52 weeks
Up to 52 weeks
Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs
Time Frame: Up to 52 weeks
Up to 52 weeks
Percentage of Participants with IEs with Laboratory Abnormalities
Time Frame: Up to 52 weeks
Up to 52 weeks
Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs
Time Frame: Up to 52 weeks
Up to 52 weeks
Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs
Time Frame: Up to 52 weeks
Up to 52 weeks
Percentage of Participants on Glucocorticoids (GCs) with AEs
Time Frame: Up to 52 weeks
Up to 52 weeks
Disease Activity Score 28 (DAS28)
Time Frame: At baseline, 24 and 52 weeks
At baseline, 24 and 52 weeks
Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)
Time Frame: At baseline, 24 and 52 weeks
At baseline, 24 and 52 weeks

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

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.
September 22, 2016

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.
December 20, 2018

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.
December 20, 2018

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).
January 5, 2016

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.
January 5, 2016

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.
January 6, 2016

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.
March 25, 2019

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.
March 22, 2019

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.
March 1, 2019

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.
  • ML29855

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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