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

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    AbbVie
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Updated on 16 February 2024
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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.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis
Age 18years - 100years
Clinical Study IdentifierNCT04267536
SponsorAbbVie
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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