Clinical trial NCT02648035: EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with rheumatoid arthritis for whom the physician has made the decision to start subcutaneous Tocilizumab treatment.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation
timeFrame: At 52 weeks
Secondary outcomes:
measure: Health Assessment Questionnaire (HAQ) Score
timeFrame: At baseline, 24 and 52 weeks
measure: Visual Analog Scale (VAS) Pain Score in a 100 mm Scale
timeFrame: At baseline, 24 and 52 weeks
measure: Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale
timeFrame: At baseline, 24 and 52 weeks
measure: Percentage of Participants with Clinically Significant Changes in Laboratory Values
timeFrame: At baseline, 24 and 52 weeks
measure: Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy
timeFrame: At baseline, 24 and 52 weeks
measure: Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)
timeFrame: At baseline, 24 and 52 weeks
measure: 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)
timeFrame: Up to 52 weeks
measure: Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs
timeFrame: Up to 52 weeks
measure: Percentage of Participants with IEs with Laboratory Abnormalities
timeFrame: Up to 52 weeks
measure: Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs
timeFrame: Up to 52 weeks
measure: Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs
timeFrame: Up to 52 weeks
measure: Percentage of Participants on Glucocorticoids (GCs) with AEs
timeFrame: Up to 52 weeks
measure: Disease Activity Score 28 (DAS28)
timeFrame: At baseline, 24 and 52 weeks
measure: Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)
timeFrame: At baseline, 24 and 52 weeks
Other outcomes:
Locations:
city: Agrinio
country: Greece
facility: Private Practice Rheumatology, Merantzis
city: Athens
country: Greece
facility: Rheumatology Private Practice
city: Athens
country: Greece
facility: General Hospital of Athens KAT, Rheumatology
city: Athens
country: Greece
facility: Rheumatology Private Practice
city: Chania
country: Greece
facility: Rheumatology Private Practice
city: Drama
country: Greece
facility: Private Practice Rheumatology, Papadimitriou
city: Eleusina
country: Greece
facility: Rheumatology Private Practice
city: Haidari
country: Greece
facility: ATTIKO Hospital_4th University Internal Medicine Clinic
city: Ioannina
country: Greece
facility: Private Practice Rheumatology, Georgiadis
city: Kalithea, Athens
country: Greece
facility: Rheumatology Private Practice
city: Karditsa
country: Greece
facility: Private Practice Rheumatology, Kotrotsios
city: Kavala
country: Greece
facility: General Hospital of Kavala; Rheumatology
city: Kifisia
country: Greece
facility: Rheumatology Private Practice
city: Larisa
country: Greece
facility: Private Practice Rehumatology, Ziogas
city: Mytilini
country: Greece
facility: General Hospital of Mytilini, Rheumatology
city: Nea Smyrni
country: Greece
facility: Private Practice Rheumatology, Trontzas
city: Patissia
country: Greece
facility: Private Practice Rheumatology, Stavropoulos
city: Patras
country: Greece
facility: Olympion Medical Center of Patras, Internal Medicine Clinic
city: Patra
country: Greece
facility: Rheumatology Private Practice
city: Serres
country: Greece
facility: Private Practice Rheumatology, Psaltis
city: Serres
country: Greece
facility: Rheumatology Private Practice
city: Thessaloniki
country: Greece
facility: Rheumatology Private Practice
city: Thessaloniki
country: Greece
facility: General Hospital Agios Pavlos
city: Thessaloniki
country: Greece
facility: Rheumatology Private Practice
city: Veroia
country: Greece
facility: Rheumatology Private Practice
city: Volos
country: Greece
facility: Rheumatology Private Practice
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: