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.
Study Type
OBSERVATIONAL
Enrollment
4,211
Kanda Orthopedics & Rheumatology Clinic /ID# 238592
Gamagōri, Aichi-ken, Japan
Handa City Hospital /ID# 232198
Handa-shi, Aichi-ken, Japan
Handa City Hospital /ID# 244106
Handa-shi, Aichi-ken, Japan
Ichinomiya Orthopedic /ID# 226814
Ichinomiya-shi, Aichi-ken, Japan
Ichinomiya Municipal Hospital /ID# 251000
Ichinomiya-shi, Aichi-ken, Japan
Haimoto Clinic /ID# 243718
Kasugai, Aichi-ken, Japan
Kasugai Orthopaedic Clinic /ID# 239041
Kasugai-shi, Aichi-ken, Japan
Sanjinkai Asahi Hospital /ID# 242397
Kasugai-shi, Aichi-ken, Japan
Kurotsuchi Orthopaedic Clinic /ID# 224194
Kasugashi, Aichi-ken, Japan
Kurotsuchi Orthopaedic Clinic /ID# 233900
Kasugashi, Aichi-ken, Japan
...and 1007 more locations
Number (Percentage) Of Participants Who Reported Of Serious Infection
Number (Percentage) of participants with incidence of serious infections are reported.
Time frame: 24 Weeks
Number (Percentage) Of Participants Who Reported Adverse Drug Reactions (ADRs)
Number (Percentage) of participants who report ADRs. An untoward medical occurrence in a participant, called an adverse event (AE) whose causal relationship with the product cannot be ruled out is considered an ADR.
Time frame: 24 Weeks
Number (Percentage) Of Participants Who Reported Of Serious Infection
Number (Percentage) of participants with incidence of serious infections are reported.
Time frame: 3 Years
Number (Percentage) Of Participants Who Reported Malignancies
Number (Percentage) of participants with incidence of malignancies are reported.
Time frame: 3 Years
Number (Percentage) Of Participants Who Reported Major Adverse Cardiovascular Events (MACE)
Number (Percentage) of participants with incidences of MACE are reported.
Time frame: 3 Years
Number (Percentage) Of Participants Who Reported Venous Thrombosis And Pulmonary Embolus (VTEs)
Number (Percentage) of participants with incidences of VTEs are reported.
Time frame: 3 Years
Percentage Of Participants Achieving Clinical Remission (CR) on Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)
CR is defined as DAS28 CRP \<2.6. The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity).
Time frame: 24 Weeks
Percentage Of Participants Achieving Low Disease Activity (LDA) on Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)
LDA is defined as DAS 28-CRP \>= 2.6 but \< 3.2. The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity).
Time frame: 24 Weeks
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