Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis (RA)
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Participants with moderate-to-severe rheumatoid arthritis (RA).

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Remission following initiation of treatment with Upadacitinib
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Participants Achieving DAS28 CRP Remission following Initiation of Treatment with Upadacitinib
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving DAS28 CRP Remission at month 6 and maintain it in all subsequent visits
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving DAS28 CRP Low Disease Activity (LDA) following Initiation of Treatment with Upadacitinib
timeFrame: Up to 12 Months
measure: Percentage of Participants Achieving DAS28 CRP Low Disease Activity at month 6 and maintain it in all subsequent visits
timeFrame: Up to 12 Months
measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: Up to 12 Months
measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
timeFrame: Up to 12 Months
measure: Change from Baseline in EQ-5D-5L Score
timeFrame: Up to 12 Months
measure: Change from Baseline in Morning Stiffness Visual Analogue Scale (VAS) Score
timeFrame: Up to 12 months
measure: Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Score
timeFrame: Up to 12 Months
measure: Change from Baseline in Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA) Score
timeFrame: Up to 12 Months
measure: Health Resource Utilization (HRU) Questionnaire - Difference in the Number of Hospital Inpatient Days
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: HRU Questionnaire - Difference in the Number of Hospitalizations
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: HRU Questionnaire - Difference in the Number of Sick Leave Days (in employed subjects only)
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: HRU Questionnaire - Difference in the Number of Sick Leaves (in employed subjects only)
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: HRU Questionnaire - Difference in the Number of Outpatient Visits to Each Kind of Health Care Provider
timeFrame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
measure: Percentage of Participants remaining on Upadacitinib treatment
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 234201
state: Gyor-Moson-Sopron
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 246156
state: Hajdu-Bihar
city: Budapest
country: Hungary
facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 234204
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 239231
city: Kistarcsa
country: Hungary
facility: Kistarcsai Flor Ferenc Korhaz /ID# 234202
city: Miskolc
country: Hungary
facility: BAZ Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 246158
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem /ID# 244364
city: Szolnok
country: Hungary
facility: MÁV Kórház /ID# 246157
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: