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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

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AbbVie

Status

Enrolling

Conditions

Ankylosing Spondylitis (AS)
Rheumatoid Arthritis (RA)
Atopic Dermatitis (AD)
Psoriatic Arthritis (PsA)

Study type

Observational

Funder types

Industry

Identifiers

NCT04541810
P20-319

Details and patient eligibility

About

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.

Enrollment

3,600 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

3,600 participants in 1 patient group

Participants receiving Upadacitinib
Description:
Participants receiving Upadacitinib as prescribed by their physician per local label.

Trial contacts and locations

118

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Central trial contact

Hansol Lee; Minje Kim

Data sourced from clinicaltrials.gov

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