Rheumatoid Arthritis
Conditions
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.
Interventions
BIOLOGICALTocilizumab
Subcutaneous Tocilizumab according to approved label.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation | At 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) Pain Score in a 100 mm Scale | At baseline, 24 and 52 weeks |
| 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 on Subcutaneous Tocilizumab Alone Versus Combination Therapy | 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 |
| Health Assessment Questionnaire (HAQ) Score | At baseline, 24 and 52 weeks |
| Percentage of Participants with IEs with Laboratory Abnormalities | 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 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 |
| Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR) | At baseline, 24 and 52 weeks |
| Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs | Up to 52 weeks |
Countries
Greece
Outcome results
None listed