Rheumatoid ArthritisUPDATENCT05327920
An Observational Study to Assess the Impact of Upadacitinib in Adult Hungarian Participants With Moderate to Severe Rheumatoid Arthritis (RA) in Real-World Practice
An observational study of Rheumatoid Arthritis, run by AbbVie at 8 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 93 participants
- Where
- 8 sitesHungary
- Study dates
- 20 Apr 2022to 22 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Participants with moderate-to-severe rheumatoid arthritis (RA).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Hungary8 sites
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 234204
Budapest, 1023
Debreceni Egyetem-Klinikai Kozpont /ID# 246156
Debrecen, Hajdú-Bihar, 4032
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 234201
Győr, Győr-Moson-Sopron, 9024
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 239231
Gyula, 5700
Kistarcsai Flor Ferenc Korhaz /ID# 234202
Kistarcsa, 2143
BAZ Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 246158
Miskolc, 3529
Szegedi Tudományegyetem /ID# 244364
Szeged, 6720
MÁV Kórház /ID# 246157
Szolnok, 5000
About this study
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
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.
Read more
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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis (RA), Upadacitinib, RINVOQ
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Upadacitinib | Participants receiving upadacitinib for Rheumatoid Arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving 28-Joint Disease Activity Score (DAS28) C-reactive protein (CRP) Remission following initiation of treatment with Upadacitinib
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.
Measured: 6 Months
Secondary outcomes (16)
Percentage of Participants Achieving DAS28 CRP Remission following Initiation of Treatment with Upadacitinib
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.
Measured: Up to 12 Months
Percentage of Participants Achieving DAS28 CRP Remission at month 6 and maintain it in all subsequent visits
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.
Measured: Up to 12 Months
Percentage of Participants Achieving DAS28 CRP Low Disease Activity (LDA) following Initiation of Treatment with Upadacitinib
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.
Measured: Up to 12 Months
Percentage of Participants Achieving DAS28 CRP Low Disease Activity at month 6 and maintain it in all subsequent visits
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.
Measured: Up to 12 Months
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
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
Measured: Up to 12 Months
Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
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.
Measured: Up to 12 Months
Change from Baseline in EQ-5D-5L Score
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).
Measured: Up to 12 Months
Change from Baseline in Morning Stiffness Visual Analogue Scale (VAS) Score
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.
Measured: Up to 12 months
Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Score
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.
Measured: Up to 12 Months
Change from Baseline in Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA) Score
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.
Measured: Up to 12 Months
Health Resource Utilization (HRU) Questionnaire - Difference in the Number of Hospital Inpatient Days
Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
HRU Questionnaire - Difference in the Number of Hospitalizations
Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
HRU Questionnaire - Difference in the Number of Sick Leave Days (in employed subjects only)
Difference in the number of hospital inpatient days during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
HRU Questionnaire - Difference in the Number of Sick Leaves (in employed subjects only)
Difference in the number of sick leaves during 12 months of upadacitinib therapy and 12 months preceding the introduction of upadacitinib therapy.
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
HRU Questionnaire - Difference in the Number of Outpatient Visits to Each Kind of Health Care Provider
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.
Measured: 12 months prior to month 0 (baseline) and 12 months prior to month 12
Percentage of Participants remaining on Upadacitinib treatment
Percentage of participants remaining on upadacitinib up to 12 months post initiation.
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 Apr 2022
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327920
- Sponsor's protocol ID
- P22-125
- Acronym
- UPDATE
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05327920
- Acronym / sponsor ID
- UPDATE / P22-125
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis (RA), Upadacitinib, RINVOQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Upadacitinib | – | –Participants receiving upadacitinib for Rheumatoid Arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Participants with moderate-to-severe rheumatoid arthritis (RA).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
16 secondary outcomes
Percentage of Participants Achieving DAS28 CRP Remission following Initiation of Treatment with Upadacitinib
Time frame: Up to 12 Months
Percentage of Participants Achieving DAS28 CRP Remission at month 6 and maintain it in all subsequent visits
Time frame: Up to 12 Months
Percentage of Participants Achieving DAS28 CRP Low Disease Activity (LDA) following Initiation of Treatment with Upadacitinib
Time frame: Up to 12 Months
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
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Time frame: Up to 12 Months
Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Time frame: Up to 12 Months
Change from Baseline in EQ-5D-5L Score
Time frame: Up to 12 Months
Change from Baseline in Morning Stiffness Visual Analogue Scale (VAS) Score
Time frame: Up to 12 months
Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Score
Time frame: Up to 12 Months
Change from Baseline in Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA) Score
Time frame: Up to 12 Months
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
HRU Questionnaire - Difference in the Number of Hospitalizations
Time frame: 12 months prior to month 0 (baseline) and 12 months prior to month 12
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
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
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
Percentage of Participants remaining on Upadacitinib treatment
Time frame: Up to 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by AbbVie at 8 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.