EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis
- 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
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subcutaneous Tocilizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation At 52 weeks
- Secondary Outcome Measures
Name Time Method 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 with IEs with Laboratory Abnormalities Up to 52 weeks Visual Analog Scale (VAS) Pain Score in a 100 mm Scale At baseline, 24 and 52 weeks Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy At baseline, 24 and 52 weeks Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs 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 Up 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) Score At 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 IEs Up to 52 weeks Percentage of Participants on Glucocorticoids (GCs) with AEs Up 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