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

AbbVie534 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

534

Conditions

Rheumatoid Arthritis (RA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of Participants Achieving Remission

Remission is defined as clinical disease activity index (CDAI) \<=2.8

Time frame: 6 Months

Secondary Outcomes

Percentage of Participants Achieving Remission

Remission is defined as the disease activity score at 28 joints (DAS28)-C-Reactive protein (CRP)\<2.6, DAS28- erythrocyte sedimentation rate (ESR)\<2.6, simplified disease activity index (SDAI)\<=3.3, CDAI\<=2.8, Boolean.

Time frame: Up to 12 Months

Percentage of Participants Achieving Low Disease Activity (LDA)

LDA is defined as DAS28-CRP\<3.2, DAS28-ESR\<3.2, SDAI \<=11, CDAI\<=10

Time frame: Up to 12 Months

Mean Change From Baseline in CDAI

The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale (VAS) from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity).

Time frame: Up to 12 Months

Mean Change From Baseline in SDAI

The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 (lowest disease activity) to 86 (highest disease activity).

Time frame: Up to 12 Months

Mean Change From Baseline in DAS28-CRP

The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity).

Time frame: Up to 12 Months

Mean Change From Baseline in DAS28-ESR

The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity).

Time frame: Up to 12 Months

Percentage of Participants Achieving Pain Reduction (Improvement by 30 %)

Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.

Time frame: Up to 12 Months

Percentage of Participants Achieving Pain Reduction (Improvement by 50 %)

Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.

Time frame: Up to 12 Months

Percentage of Participants Achieving Pain Reduction (Improvement by 70 %)

Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.

Time frame: Up to 12 Months

Mean Change From Baseline in Pain

The NRS of Pain sheet will be filled out in the office by participants at the designated visits.

Time frame: Up to 12 Months

Percentage of Participants Achieving Fatigue Reduction (Improvement by 30 %)

Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.

Time frame: Up to 12 Months

Percentage of Participants Achieving Fatigue Reduction (Improvement by 50 %)

Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.

Time frame: Up to 12 Months

Percentage of Participants Achieving Fatigue Reduction (Improvement by 70 %)

Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.

Time frame: Up to 12 Months

Mean Change From Baseline in Fatigue

Change in Fatigue is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.

Time frame: Up to 12 Months

Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID)