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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatoid Arthritis (RA)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All participants treated with RINVOQ. Exclusion Criteria: - Participants not taking RINVOQ.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants treated with RINVOQ<br>Participants treated with upadacitinib in accordance with approved local label. Decision to treat with upadacitinib was made prior to offering participation in this study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (Percentage) Of Participants Who Reported Of Serious Infection | Number (Percentage) of participants with incidence of serious infections are reported. | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 Weeks | 
| Number (Percentage) Of Participants Who Reported Of Serious Infection | Number (Percentage) of participants with incidence of serious infections are reported. | 3 Years | 
| Number (Percentage) Of Participants Who Reported Malignancies | Number (Percentage) of participants with incidence of malignancies are reported. | 3 Years | 
| Number (Percentage) Of Participants Who Reported Major Adverse Cardiovascular Events (MACE) | Number (Percentage) of participants with incidences of MACE are reported. | 3 Years | 
| Number (Percentage) Of Participants Who Reported Venous Thrombosis And Pulmonary Embolus (VTEs) | Number (Percentage) of participants with incidences of VTEs are reported. | 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). | 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). | 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis (RA), RINVOQ, Upadacitinib, ABT-494