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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2024-04-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants Receiving Upadacitinib

Participants receiving upadacitinib for Rheumatoid Arthritis

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No