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NCT Number: NCT04340115

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

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.

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanda Orthopedics & Rheumatology Clinic /ID# 238592, Gamagōri, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants treated with RINVOQ.

Exclusion criteria

  • Participants not taking RINVOQ.

Treatment and study plan

Primary outcomes

  1. Number (Percentage) Of Participants Who Reported Of Serious Infection

    Time frame: 24 Weeks

    Number (Percentage) of participants with incidence of serious infections are reported.

Secondary outcomes

  1. Number (Percentage) Of Participants Who Reported Adverse Drug Reactions (ADRs)

    Time frame: 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.

  2. Number (Percentage) Of Participants Who Reported Of Serious Infection

    Time frame: 3 Years

    Number (Percentage) of participants with incidence of serious infections are reported.

  3. Number (Percentage) Of Participants Who Reported Malignancies

    Time frame: 3 Years

    Number (Percentage) of participants with incidence of malignancies are reported.

  4. Number (Percentage) Of Participants Who Reported Major Adverse Cardiovascular Events (MACE)

    Time frame: 3 Years

    Number (Percentage) of participants with incidences of MACE are reported.

  5. Number (Percentage) Of Participants Who Reported Venous Thrombosis And Pulmonary Embolus (VTEs)

    Time frame: 3 Years

    Number (Percentage) of participants with incidences of VTEs are reported.

  6. Percentage Of Participants Achieving Clinical Remission (CR) on Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)

    Time frame: 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).

  7. Percentage Of Participants Achieving Low Disease Activity (LDA) on Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2020
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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