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NCT Number: NCT05327920

An Observational Study to Assess the Impact of Upadacitinib in Adult Hungarian Participants With Moderate to Severe Rheumatoid Arthritis (RA) in Real-World Practice

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the impact of upadacitinib treatment on achievement of remission and low disease activity in moderate to severe RA Hungarian patients in the real-world setting.

Upadacitinib is an approved drug for the treatment of adults with moderately to severely active RA. Adult participants with moderate-to-severe RA will be enrolled. Around 90 participants who are prescribed upadacitinib in routine clinical practice will be enrolled in the study in approximately 8 sites in Hungary.

Participants will receive upadacitinib as prescribed by the physician and will be followed for approximately 12 months.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 234201, Győr, Győr-Moson-Sopron, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of moderate to severe active rheumatoid arthritis (RA) upon judgment of the treating physician.
  • Upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies and upadacitinib treatment was started within 1 week before the enrollment.
  • Physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study.

Exclusion criteria

  • Participants who cannot be treated with upadacitinib as per SmPC or local prescription criteria.
  • Prior treatment course with upadacitinib or the current upadacitinib treatment was started more than 1 week prior to enrollment.
  • Participant currently participating in any interventional study.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Remission following initiation of treatment with Upadacitinib

    Time frame: 6 Months

    The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Remission is defined as a DAS28 CRP <2.6.

Secondary outcomes

  1. Percentage of Participants Achieving DAS28 CRP Remission following Initiation of Treatment with Upadacitinib

    Time frame: Up to 12 Months

    The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Remission is defined as a DAS28 CRP <2.6.

  2. Percentage of Participants Achieving DAS28 CRP Remission at month 6 and maintain it in all subsequent visits

    Time frame: Up to 12 Months

    The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Remission is defined as a DAS28 CRP <2.6.

  3. Percentage of Participants Achieving DAS28 CRP Low Disease Activity (LDA) following Initiation of Treatment with Upadacitinib

    Time frame: Up to 12 Months

    The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Low disease activity is defined as DAS28 CRP <=3.2.

  4. Percentage of Participants Achieving DAS28 CRP Low Disease Activity at month 6 and maintain it in all subsequent visits

    Time frame: Up to 12 Months

    The DAS28 CRP is a composite measure of a patient's level of disease activity at a given time. The score ranges from 0-9.4 with a higher score correlating to higher disease activity. Low disease activity is defined as DAS28 CRP <=3.2.

  5. Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

    Time frame: Up to 12 Months

    The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment

  6. Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score

    Time frame: Up to 12 Months

    The FACIT-Fatigue Scale measures an individual's level of fatigue during their usual daily activities over the past week on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The score range for FACIT-Fatigue is between 0 and 52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life.

  7. Change from Baseline in EQ-5D-5L Score

    Time frame: Up to 12 Months

    The EQ-5D-5L comprises of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The respondent selects one of three different levels of problem severity. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively).

  8. Change from Baseline in Morning Stiffness Visual Analogue Scale (VAS) Score

    Time frame: Up to 12 months

    The participant's level of morning stiffness in the past 7 days will be measured using a VAS. VAS scores range from 0 to 100 points with a higher score indicating severity of morning stiffness.

  9. Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Score

    Time frame: Up to 12 Months

    TSQM scores have a range of 0 to 100, with higher scores indicating higher satisfaction. The 14 items of the TSQM cover four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction.

  10. Change from Baseline in Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA) Score

    Time frame: Up to 12 Months

    The WPAI-RA measures the impact of health problems on presenteeism, absenteeism, total work productivity impairment, total activity impairment using a 0 to 10 VAS.

  11. Health Resource Utilization (HRU) Questionnaire - Difference in the Number of Hospital Inpatient Days

    Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12

    Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.

  12. HRU Questionnaire - Difference in the Number of Hospitalizations

    Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12

    Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.

  13. HRU Questionnaire - Difference in the Number of Sick Leave Days (in employed subjects only)

    Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12

    Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.

  14. HRU Questionnaire - Difference in the Number of Sick Leaves (in employed subjects only)

    Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12

    Difference in the number of sick leaves during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.

  15. HRU Questionnaire - Difference in the Number of Outpatient Visits to Each Kind of Health Care Provider

    Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12

    Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurses during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.

  16. Percentage of Participants remaining on Upadacitinib treatment

    Time frame: Up to 12 Months

    Percentage of participants remaining on upadacitinib up to 12 months post initiation.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Impact of UPaDacitinib Treatment on inflAmmaTion, AchiEvement of Treatment Targets and Health-related Quality of Life, Work Ability and Healthcare Resource Utilization in Moderate to Severe Rheumatoid Arthritis Patients in Hungarian Real-world Practice

Acronym: UPDATE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 14, 2022
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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