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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

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

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
Intervention / Treatment
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

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

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

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)

September 22, 2016

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 22, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Tocilizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe