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 Identifier
P22-125
CT.gov Identifier
NCT05327920
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 234201
    Győr, Győr-Moson-Sopron, Hungary, 9024
    Status
    Not applicable
    Location
    Debreceni Egyetem-Klinikai Kozpont /ID# 246156
    Debrecen, Hajdú-Bihar, Hungary, 4032
    Status
    Not applicable
    Location
    Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 234204
    Budapest, Hungary, 1023
    Status
    Not applicable
    Location
    Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 239231
    Gyula, Hungary, 5700
    Status
    Not applicable
    Location
    Kistarcsai Flor Ferenc Korhaz /ID# 234202
    Kistarcsa, Hungary, 2143
    Status
    Not applicable
    Location
    BAZ Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 246158
    Miskolc, Hungary, 3529
    Status
    Not applicable
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