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.
Study Type
OBSERVATIONAL
Enrollment
200
Subcutaneous Tocilizumab according to approved label.
Private Practice Rheumatology, Merantzis
Agrinio, Greece
Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation
Time frame: At 52 weeks
Health Assessment Questionnaire (HAQ) Score
Time frame: At baseline, 24 and 52 weeks
Visual Analog Scale (VAS) Pain Score in a 100 mm Scale
Time frame: At baseline, 24 and 52 weeks
Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants with Clinically Significant Changes in Laboratory Values
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)
Time frame: 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)
Time frame: Up to 52 weeks
Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs
Time frame: Up to 52 weeks
Percentage of Participants with IEs with Laboratory Abnormalities
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Time frame: 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
Time frame: Up to 52 weeks
Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs
Time frame: Up to 52 weeks
Percentage of Participants on Glucocorticoids (GCs) with AEs
Time frame: Up to 52 weeks
Disease Activity Score 28 (DAS28)
Time frame: At baseline, 24 and 52 weeks
Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)
Time frame: At baseline, 24 and 52 weeks