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

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis (RA)

Study type: Observational

Funder types: Industry

Identifiers

NCT04340115

P19-565

Details and patient eligibility

About

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.

Enrollment: 4,211 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- All participants treated with RINVOQ.

Exclusion criteria

- Participants not taking RINVOQ.

Trial design

4,211 participants in 1 patient group

Participants treated with RINVOQ

Description:

Participants treated with upadacitinib in accordance with approved local label. Decision to treat with upadacitinib was made prior to offering participation in this study.