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

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648035
• Other study ID #: ML29855
• Status: Completed
• Start date: September 22, 2016
• Est. completion date: December 20, 2018

Study information

• Verified date: March 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Tocilizumab
Subcutaneous Tocilizumab according to approved label.

Locations

Country	Name	City	State
Greece	Private Practice Rheumatology, Merantzis	Agrinio
Greece	General Hospital of Athens KAT, Rheumatology	Athens
Greece	Rheumatology Private Practice	Athens
Greece	Rheumatology Private Practice	Athens
Greece	Rheumatology Private Practice	Chania
Greece	Private Practice Rheumatology, Papadimitriou	Drama
Greece	Rheumatology Private Practice	Eleusina
Greece	ATTIKO Hospital_4th University Internal Medicine Clinic	Haidari
Greece	Private Practice Rheumatology, Georgiadis	Ioannina
Greece	Rheumatology Private Practice	Kalithea, Athens
Greece	Private Practice Rheumatology, Kotrotsios	Karditsa
Greece	General Hospital of Kavala; Rheumatology	Kavala
Greece	Rheumatology Private Practice	Kifisia
Greece	Private Practice Rehumatology, Ziogas	Larisa
Greece	General Hospital of Mytilini, Rheumatology	Mytilini
Greece	Private Practice Rheumatology, Trontzas	Nea Smyrni
Greece	Private Practice Rheumatology, Stavropoulos	Patissia
Greece	Rheumatology Private Practice	Patra
Greece	Olympion Medical Center of Patras, Internal Medicine Clinic	Patras
Greece	Private Practice Rheumatology, Psaltis	Serres
Greece	Rheumatology Private Practice	Serres
Greece	General Hospital Agios Pavlos	Thessaloniki
Greece	Rheumatology Private Practice	Thessaloniki
Greece	Rheumatology Private Practice	Thessaloniki
Greece	Rheumatology Private Practice	Veroia
Greece	Rheumatology Private Practice	Volos

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation		At 52 weeks
Secondary	Health Assessment Questionnaire (HAQ) Score		At baseline, 24 and 52 weeks
Secondary	Visual Analog Scale (VAS) Pain Score in a 100 mm Scale		At baseline, 24 and 52 weeks
Secondary	Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale		At baseline, 24 and 52 weeks
Secondary	Percentage of Participants with Clinically Significant Changes in Laboratory Values		At baseline, 24 and 52 weeks
Secondary	Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy		At baseline, 24 and 52 weeks
Secondary	Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)		At baseline, 24 and 52 weeks
Secondary	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
Secondary	Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs		Up to 52 weeks
Secondary	Percentage of Participants with IEs with Laboratory Abnormalities		Up to 52 weeks
Secondary	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
Secondary	Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs		Up to 52 weeks
Secondary	Percentage of Participants on Glucocorticoids (GCs) with AEs		Up to 52 weeks
Secondary	Disease Activity Score 28 (DAS28)		At baseline, 24 and 52 weeks
Secondary	Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)		At baseline, 24 and 52 weeks