An Observational Study to Assess the Impact of Upadacitinib in Adult Hungarian Participants With Moderate to Severe Rheumatoid Arthritis (RA) in Real-World Practice (UPDATE)

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AbbVie

Status

Completed

Conditions

Rheumatoid Arthritis

Study type

Observational

Funder types

Industry

Identifiers

NCT05327920
P22-125

Details and patient eligibility

About

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the impact of upadacitinib treatment on achievement of remission and low disease activity in moderate to severe RA Hungarian patients in the real-world setting. Upadacitinib is an approved drug for the treatment of adults with moderately to severely active RA. Adult participants with moderate-to-severe RA will be enrolled. Around 90 participants who are prescribed upadacitinib in routine clinical practice will be enrolled in the study in approximately 8 sites in Hungary. Participants will receive upadacitinib as prescribed by the physician and will be followed for approximately 12 months. 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 only data which are routinely collected during a regular visit will be utilized for this study.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of moderate to severe active rheumatoid arthritis (RA) upon judgment of the treating physician.
  • Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies and upadacitinib treatment was started within 1 week before the enrollment.
  • Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.

Exclusion criteria

  • Participants who cannot be treated with upadacitinib as per SmPC or local prescription criteria.
  • Prior treatment course with upadacitinib or the current upadacitinib treatment was started more than 1 week prior to enrollment.
  • Participant currently participating in any interventional study.

Trial design

93 participants in 1 patient group

Participants Receiving Upadacitinib
Description:
Participants receiving upadacitinib for Rheumatoid Arthritis

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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