EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis
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.
1 other identifier
observational
200
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Typical duration for all trials
26 active sites
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
January 5, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedStudy Start
First participant enrolled
September 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedMarch 25, 2019
March 1, 2019
2.2 years
January 5, 2016
March 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation
At 52 weeks
Secondary Outcomes (14)
Health Assessment Questionnaire (HAQ) Score
At baseline, 24 and 52 weeks
Visual Analog Scale (VAS) Pain Score in a 100 mm Scale
At baseline, 24 and 52 weeks
Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale
At baseline, 24 and 52 weeks
Percentage of Participants with Clinically Significant Changes in Laboratory Values
At baseline, 24 and 52 weeks
Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy
At baseline, 24 and 52 weeks
- +9 more secondary outcomes
Study Arms (1)
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.
Interventions
Subcutaneous Tocilizumab according to approved label.
Eligibility Criteria
Participants with rheumatoid arthritis for whom the physician has made the decision to start subcutaneous Tocilizumab treatment.
You may qualify if:
- \- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Private Practice Rheumatology, Merantzis
Agrinio, 301 00, Greece
Rheumatology Private Practice
Athens, 11521, Greece
General Hospital of Athens KAT, Rheumatology
Athens, 14527, Greece
Rheumatology Private Practice
Athens, Greece
Private Practice Rheumatology, Stavropoulos
Áno Patísia, Greece
Rheumatology Private Practice
Chania, 731 00, Greece
Private Practice Rheumatology, Papadimitriou
Drama, 66132, Greece
Rheumatology Private Practice
Eleusina, 19200, Greece
ATTIKO Hospital_4th University Internal Medicine Clinic
Haidari, 124 62, Greece
Private Practice Rheumatology, Georgiadis
Ioannina, 453 33, Greece
Rheumatology Private Practice
Kalithea, Athens, 17673, Greece
Private Practice Rheumatology, Kotrotsios
Karditsa, 431 00, Greece
General Hospital of Kavala; Rheumatology
Kavala, 65500, Greece
Rheumatology Private Practice
Kifissia, Greece
Private Practice Rehumatology, Ziogas
Larissa, 412 21, Greece
General Hospital of Mytilini, Rheumatology
Mytilene, 811 00, Greece
Private Practice Rheumatology, Trontzas
Néa Smýrni, 171 21, Greece
Rheumatology Private Practice
Pátrai, 26221, Greece
Olympion Medical Center of Patras, Internal Medicine Clinic
Pátrai, 26443, Greece
Private Practice Rheumatology, Psaltis
Serres, 621 22, Greece
Rheumatology Private Practice
Serres, 62122, Greece
Rheumatology Private Practice
Thessaloniki, 54621, Greece
General Hospital Agios Pavlos
Thessaloniki, Greece
Rheumatology Private Practice
Thessaloniki, Greece
Rheumatology Private Practice
Véroia, 59100, Greece
Rheumatology Private Practice
Volos, 38221, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2016
First Posted
January 6, 2016
Study Start
September 22, 2016
Primary Completion
December 20, 2018
Study Completion
December 20, 2018
Last Updated
March 25, 2019
Record last verified: 2019-03