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

Completed
Conditions
Rheumatoid Arthritis
Interventions
Biological: Tocilizumab
Registration Number
NCT02648035
Lead Sponsor
Hoffmann-La Roche
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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.
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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).
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Subcutaneous TocilizumabTocilizumabParticipants receiving treatment for rheumatoid arthritis (RA) with subcutaneous Tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) according to approved label.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of ObservationAt 52 weeks
Secondary Outcome Measures
NameTimeMethod
Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS ScaleAt baseline, 24 and 52 weeks
Percentage of Participants with Clinically Significant Changes in Laboratory ValuesAt baseline, 24 and 52 weeks
Percentage of Participants with IEs with Laboratory AbnormalitiesUp to 52 weeks
Visual Analog Scale (VAS) Pain Score in a 100 mm ScaleAt baseline, 24 and 52 weeks
Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination TherapyAt baseline, 24 and 52 weeks
Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEsUp 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 IEsUp to 52 weeks
Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)At baseline, 24 and 52 weeks
Health Assessment Questionnaire (HAQ) ScoreAt baseline, 24 and 52 weeks
Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)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)Up to 52 weeks
Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEsUp to 52 weeks
Percentage of Participants on Glucocorticoids (GCs) with AEsUp to 52 weeks
Disease Activity Score 28 (DAS28)At baseline, 24 and 52 weeks

Trial Locations

Locations (15)

Private Practice Rheumatology, Merantzis

🇬🇷

Agrinio, Greece

ATTIKO Hospital_4th University Internal Medicine Clinic

🇬🇷

Haidari, Greece

General Hospital of Mytilini, Rheumatology

🇬🇷

Mytilini, Greece

General Hospital of Athens KAT, Rheumatology

🇬🇷

Athens, Greece

Private Practice Rheumatology, Papadimitriou

🇬🇷

Drama, Greece

General Hospital of Kavala; Rheumatology

🇬🇷

Kavala, Greece

Rheumatology Private Practice

🇬🇷

Volos, Greece

Private Practice Rheumatology, Georgiadis

🇬🇷

Ioannina, Greece

Private Practice Rheumatology, Stavropoulos

🇬🇷

Patissia, Greece

Olympion Medical Center of Patras, Internal Medicine Clinic

🇬🇷

Patras, Greece

Private Practice Rheumatology, Psaltis

🇬🇷

Serres, Greece

Private Practice Rheumatology, Trontzas

🇬🇷

Nea Smyrni, Greece

General Hospital Agios Pavlos

🇬🇷

Thessaloniki, Greece

Private Practice Rheumatology, Kotrotsios

🇬🇷

Karditsa, Greece

Private Practice Rehumatology, Ziogas

🇬🇷

Larisa, Greece

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