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

NCT ID: NCT02648035

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-22

Study Completion Date

2018-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Tocilizumab

Intervention Type BIOLOGICAL

Subcutaneous Tocilizumab according to approved label.

Interventions

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Tocilizumab

Subcutaneous Tocilizumab according to approved label.

Intervention Type BIOLOGICAL

Other Intervention Names

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ACTEMRA

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Private Practice Rheumatology, Merantzis

Agrinio, , Greece

Site Status

Rheumatology Private Practice

Athens, , Greece

Site Status

General Hospital of Athens KAT, Rheumatology

Athens, , Greece

Site Status

Rheumatology Private Practice

Athens, , Greece

Site Status

Private Practice Rheumatology, Stavropoulos

Áno Patísia, , Greece

Site Status

Rheumatology Private Practice

Chania, , Greece

Site Status

Private Practice Rheumatology, Papadimitriou

Drama, , Greece

Site Status

Rheumatology Private Practice

Eleusina, , Greece

Site Status

ATTIKO Hospital_4th University Internal Medicine Clinic

Haidari, , Greece

Site Status

Private Practice Rheumatology, Georgiadis

Ioannina, , Greece

Site Status

Rheumatology Private Practice

Kalithea, Athens, , Greece

Site Status

Private Practice Rheumatology, Kotrotsios

Karditsa, , Greece

Site Status

General Hospital of Kavala; Rheumatology

Kavala, , Greece

Site Status

Rheumatology Private Practice

Kifissia, , Greece

Site Status

Private Practice Rehumatology, Ziogas

Larissa, , Greece

Site Status

General Hospital of Mytilini, Rheumatology

Mytilene, , Greece

Site Status

Private Practice Rheumatology, Trontzas

Néa Smýrni, , Greece

Site Status

Rheumatology Private Practice

Pátrai, , Greece

Site Status

Olympion Medical Center of Patras, Internal Medicine Clinic

Pátrai, , Greece

Site Status

Private Practice Rheumatology, Psaltis

Serres, , Greece

Site Status

Rheumatology Private Practice

Serres, , Greece

Site Status

Rheumatology Private Practice

Thessaloniki, , Greece

Site Status

General Hospital Agios Pavlos

Thessaloniki, , Greece

Site Status

Rheumatology Private Practice

Thessaloniki, , Greece

Site Status

Rheumatology Private Practice

Véroia, , Greece

Site Status

Rheumatology Private Practice

Volos, , Greece

Site Status

Countries

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Greece

Other Identifiers

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ML29855

Identifier Type: -

Identifier Source: org_study_id

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