NCT04340115

Study To Assess Frequency Of Serious Infections In Clinical Practice In Japan For Adult Participants With Rheumatoid Arthritis Receiving Oral RINVOQ Tablets

Special Drug Use - Results Survey Of Evaluating Safety And Effectiveness Of RINVOQ In Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,211 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. The purpose of this study is to observe the incidence of serious infections, regardless of their relationship to RINVOQ, in Japanese daily practice. RINVOQ is an approved drug for the treatment of adults with moderately to severely active RA. This study evaluates medical records from institutions participating in the study to identify any adverse events (untoward medical occurrence), and reasons for discontinuation of RINVOQ in participants taking the study drug. A target of 1000 Japanese participants' data will be observed for 3 years. Participants will receive RINVOQ per their physicians' usual prescription. Individual data will be collected for three years. No additional study-related tests will be conducted during routine clinic visits. Only data which are routinely collected during clinic visits will be utilized for this study.

Conditions

• Rheumatoid Arthritis (RA)

Timeline

• Start date: 2020-04-24
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2020-04-09
• Last updated: 2025-11-17

Locations

1,017 sites across 1 country: Japan