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

Recruiting

• Conditions: Ankylosing Spondylitis (AS); Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA); Atopic Dermatitis (AD)

• Registration Number: NCT04541810
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2021-01-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	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 Eczema Area and Severity Index (EASI) (Atopic Dermatitis Participants Only)	Up to 16 weeks	Responder is a participant who achieve EASI 75.
Percentage of Participants Achieving the Responder status Based on Active Joint Count (Psoriatic Arthritis Participants Only)	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.
Percentage of Participants Achieving Responder Status Based on Disease Activity Score 28 Joints (DAS28) (Rheumatoid Arthritis Participants Only)	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 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (Ankylosing Spondylitis Participants Only)	Up to 12 weeks	Responder is a participant whose BASDAI at week 12 decreased by 50% or more than 2 compared to the baseline.

Trial Locations

Locations (116)

Inje University - Busan Paik Hospital /ID# 259143; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Haeundae Bumin Hospital /ID# 238959; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Inje University Haeundae Hospital /ID# 238949; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Pusan National University Hospital /ID# 251315; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Kosin University Gospel Hospital /ID# 239001; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Chungbuk National University Hospital /ID# 238997; 🇰🇷 Cheongju, Chungcheongbugdo, Korea, Republic of

Chungbuk National University Hospital /ID# 262334; 🇰🇷 Cheongju, Chungcheongbugdo, Korea, Republic of

Dr. Park's Internal Medicine Clinic /ID# 238995; 🇰🇷 Chungbuk, Chungcheongbugdo, Korea, Republic of

Konkuk University Chungju Hospital /ID# 240936; 🇰🇷 Chungju, Chungcheongbugdo, Korea, Republic of

Dankook University Hospital /ID# 251307; 🇰🇷 Cheonan-si, Chungcheongnamdo, Korea, Republic of

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