A Study of Oral Upadacitinib (RINVOQ) Tablets to Assess Adverse Events and Change in Disease Symptoms in Korean Participants With Moderate to Severe Active Rheumatoid Arthritis, Atopic Dermatitis, Ankylosing Spondylitis or Psoriatic Arthritis

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints characterized by the swelling of multiple joints and tenderness caused by progressive inflammatory synovitis, which leads to serious and debilitating diseases. Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Ankylosing Spondylitis (AS) is a form of chronic arthritis causing inflammation in the spine. This can cause pain and stiffness in the back. Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. This study will assess the adverse events and change in disease symptoms in Korean participants with RA, AD, AS or PsA.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis, atopic dermatitis, ankylosing spondylitis or psoriatic arthritis. Korean participants who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 3600 participants will be enrolled this study, in multiple sites within Korea.

Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 28 weeks.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

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Key information

Conditions

Rheumatoid Arthritis (RA) Ankylosing Spondylitis (AS) Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Atopic Dermatitis (AD) Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis (PsA) Rheumatic Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dong-A University Medical Center /ID# 269937, Busan, Busan Gwang Yeogsi, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult participants (>= 19 years of age), Atopic dermatitis includes both adolescents (>= 12 years of age) and adults.
Participants suitable for the treatment with upadacitinib according to the approved local label.

Exclusion criteria

Participants for whom the drug is contraindicated in the approved local label.

Treatment and study plan

Primary outcomes

Percentage of Participants With Adverse Events

Time frame: Up to approximately 6 years

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment.
Percentage of Participants Achieving Responder Status Based on Disease Activity Score 28 Joints (DAS28) (Rheumatoid Arthritis Participants Only)

Time frame: Up to 24 weeks

Responder is a participant whose DAS28 at week 24 decreased by 1.2 or more compared to baseline.
Percentage of Participants Achieving Responder Status Based on Eczema Area and Severity Index (EASI) (Atopic Dermatitis Participants Only)

Time frame: Up to 16 weeks

Responder is a participant who achieve EASI 75.
Percentage of Participants Achieving Responder Status Based on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (Ankylosing Spondylitis Participants Only)

Time frame: Up to 12 weeks

Responder is a participant whose BASDAI at week 12 decreased by 50% or more than 2 compared to the baseline.
Percentage of Participants Achieving the Responder status Based on Active Joint Count (Psoriatic Arthritis Participants Only)

Time frame: Up to 12 weeks

Responder is a participant who achieve 30% or more reduction in Tender Joint Count and Swollen Joint Count compared to Baseline.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib in Korean Patients

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Sep 9, 2020
Registry last updated: Feb 12, 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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