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 (UPWARDS)

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis (RA)

Study type: Observational

Funder types: Industry

Identifiers

NCT04267536

P20-078

Details and patient eligibility

About

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.

Enrollment: 534 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

534 participants in 2 patient groups

Participants treated with upadacitinib monotherapy

Description:

Participants will receive upadacitinib for 12 months as prescribed by the physician

Participants treated with upadacitinib in combination with MTX

Description:

Participants will receive upadacitinib in combination with MTX as prescribed by the physician for 12 months