An Observational Study to Evaluate Impact of CRP-Level on Real World Effectiveness of Upadacitinib as Monotherapy or in Combination With MTX in Adult Participants With Rheumatoid Arthritis

Study Identifier
P20-078
CT.gov Identifier
NCT04267536
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. * Swollen Joint Count (SJC) \>= 3 of 28 joints of the Disease Activity Score (DAS)28. * Measurement of C-Reactive Protein (CRP)-level at Baseline (BL) or \<= 4 weeks prior to BL at a timepoint when the Prednisolone equivalent dose of Glucocorticoid treatment was \<= 10 mg/day for at least 7 days. * Upadacitinib treatment is indicated as per local Summary of Product characteristics (SmPC). * Decision on the treatment with Upadacitinib was made prior to any decision to approach the patient to participate in this study.
    Exclusion Criteria:
    * Participants who cannot be treated with Upadacitinib according to the local Upadacitinib SmPC. * Prior treatment with Upadacitinib. * Treatment with Sarilumab or Tocilizumab within the last 8 weeks before the CRP level for inclusion was measured. * Participants currently participating in interventional research. * Participants who are unwilling or unable to complete the patient reported questionnaires.

    Protocol Summary

    Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study assesses whether C-reactive protein (CRP)-level has an impact on achieving remission with upadacitinib when used alone or in combination with methotrexate (MTX). This study will also assess the reduction in pain, morning stiffness, fatigue, functionality, health status and impact of RA.

    CRP is an indicator of inflammation and often used for disease activity monitoring during RA treatment. Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. This study has two groups - upadacitinib monotherapy and combination. Adult participants with moderate to severe RA will be enrolled. Around 500 participants will be enrolled in the study in multiple sites within Germany.

    Participants will receive upadacitinib alone or in combination with MTX per their physicians' usual prescription. Individual data will be collected for 12 months.

    No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.

    Study Locations

    Location
    Status
    Location
    Praxis Dr. Rinaldi /ID# 218424
    Ulm, Baden-Wurttemberg, Germany, 89073
    Status
    Not applicable
    Location
    Praxis Dres. Kellerer/Kellerer/Krüger /ID# 218428
    Munich, Bavaria, Germany, 81541
    Status
    Not applicable
    Location
    Rheumahaus Studien GbR, Potsdam, DE /ID# 218430
    Potsdam, Brandenburg, Germany, 14467
    Status
    Not applicable
    Location
    Rheumazentrum Ruhrgebiet /ID# 221388
    Herne, North Rhine-Westphalia, Germany, 44649
    Status
    Not applicable
    Location
    Praxis Dr. Lüthke /ID# 218900
    Dresden, Saxony, Germany, 01097
    Status
    Not applicable
    Location
    Kupka & Kupka, Altenburg, DE /ID# 218413
    Altenburg, Germany, 04600
    Status
    Not applicable
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