Study To Assess Frequency Of Serious Infections In Clinical Practice In Japan For Adult Participants With Rheumatoid Arthritis Receiving Oral RINVOQ Tablets
- Conditions
- Rheumatoid Arthritis (RA)
- Registration Number
- NCT04340115
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- All participants treated with RINVOQ.
- Participants not taking RINVOQ.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number (Percentage) Of Participants Who Reported Of Serious Infection 24 Weeks Number (Percentage) of participants with incidence of serious infections are reported.
- Secondary Outcome Measures
Name Time Method Number (Percentage) Of Participants Who Reported Adverse Drug Reactions (ADRs) 24 Weeks 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.
Number (Percentage) Of Participants Who Reported Malignancies 3 Years Number (Percentage) of participants with incidence of malignancies are reported.
Number (Percentage) Of Participants Who Reported Major Adverse Cardiovascular Events (MACE) 3 Years Number (Percentage) of participants with incidences of MACE are reported.
Number (Percentage) Of Participants Who Reported Of Serious Infection 3 Years Number (Percentage) of participants with incidence of serious infections are reported.
Number (Percentage) Of Participants Who Reported Venous Thrombosis And Pulmonary Embolus (VTEs) 3 Years Number (Percentage) of participants with incidences of VTEs are reported.
Percentage Of Participants Achieving Clinical Remission (CR) on Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) 24 Weeks 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).
Percentage Of Participants Achieving Low Disease Activity (LDA) on Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP) 24 Weeks 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).
Trial Locations
- Locations (1004)
Kanda Orthopedics & Rheumatology Clinic /ID# 238592
🇯🇵Gamagori, Aichi, Japan
Handa City Hospital /ID# 232198
🇯🇵Handa-shi, Aichi, Japan
Handa City Hospital /ID# 244106
🇯🇵Handa-shi, Aichi, Japan
Ichinomiya Orthopedic /ID# 226814
🇯🇵Ichinomiya-shi, Aichi, Japan
Ichinomiya Municipal Hospital /ID# 251000
🇯🇵Ichinomiya-shi, Aichi, Japan
Haimoto Clinic /ID# 243718
🇯🇵Kasugai City, Aichi, Japan
Sanjinkai Asahi Hospital /ID# 242397
🇯🇵Kasugai-shi, Aichi, Japan
Kurotsuchi Orthopaedic Clinic /ID# 224194
🇯🇵Kasugashi, Aichi, Japan
Kurotsuchi Orthopaedic Clinic /ID# 233900
🇯🇵Kasugashi, Aichi, Japan
Komaki City Hospital /ID# 232586
🇯🇵Komaki-shi, Aichi, Japan
Scroll for more (994 remaining)Kanda Orthopedics & Rheumatology Clinic /ID# 238592🇯🇵Gamagori, Aichi, Japan