A Comparison Study of Persistence of UPadacitinib vs. TNF-inhibitoRs In a German Real-world SettING

Study Identifier
P25-188
CT.gov Identifier
NCT06712628
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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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:
    * Current or Past participants with a confirmed diagnosis of moderate to severe active RA upon judgement of the treating physician. * Physician decision on participant treatment with Upadacitinib (UPA) or tumor necrosis factor inhibitor (TNFi) must have been reached prior to and independently of recruitment in the study * UPA or TNFi prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies
    Exclusion Criteria:
    * Participation in a clinical trial with an investigational drug (within a minimum of 30 days or 5 half-lives of the investigational drug \[whichever is longer\] prior to baseline) * Prior treatment with Upadacitinib * Prior treatment with the same tumor necrosis factor inhibitor as the one prescribed for this study

    Protocol Summary

    This study will compare the retention rates for UPA vs. TNFi treatment in adult participants with moderate to severe active RA per local label and according to local standard of care

    This is a mono-country, prospective, multi-center observational study in patients with moderate to severe active RA receiving UPA or TNFi therapy. Around 678 participants will be enrolled in approximately 80 sites in Germany.

    Study recruitment will last approximately 24 months, and the study participation time will be up to 24 months, for a total study duration of approximately 48 months.

    Study Locations

    Location
    Status
    Location
    Gemeinschaftspraxis Innere Medizin/Rheumatologie /ID# 278584
    Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79098
    Status
    Recruiting
    Location
    Rheumapraxis Heidelberg /ID# 276475
    Heidelberg, Baden-Wurttemberg, Germany, 69120
    Status
    Recruiting
    Location
    Rheumapraxis Haas Tübingen /ID# 275536
    Tübingen, Baden-Wurttemberg, Germany, 72072
    Status
    Recruiting
    Location
    Rheumapraxis Ulm Dr. med. Nadia Rinaldi /ID# 276293
    Ulm, Baden-Wurttemberg, Germany, 89073
    Status
    Recruiting
    Location
    Dr. Med. Thomas Marycz /ID# 274646
    Amberg, Bavaria, Germany, 92224
    Status
    Recruiting
    Location
    Rheumapraxis Am Webereck /ID# 274412
    Augsburg, Bavaria, Germany, 86157
    Status
    Recruiting
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