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

NCT05327920 | Completed

• 1 other identifier: P22-125
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 8

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis (RA); Upadacitinib; RINVOQ

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (16)

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

  Up to 12 Months

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

  Up to 12 Months

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

  Up to 12 Months

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

  Up to 12 Months

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

  Up to 12 Months

Study Arms (1)

Participants Receiving Upadacitinib

Participants receiving upadacitinib for Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Participants with moderate-to-severe rheumatoid arthritis (RA).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (8)

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

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Debreceni Egyetem-Klinikai Kozpont /ID# 246156

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 234204

Budapest, 1023, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 239231

Gyula, 5700, Hungary

Location

Kistarcsai Flor Ferenc Korhaz /ID# 234202

Kistarcsa, 2143, Hungary

Location

BAZ Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 246158

Miskolc, 3529, Hungary

Location

Szegedi Tudományegyetem /ID# 244364

Szeged, 6720, Hungary

Location

MÁV Kórház /ID# 246157

Szolnok, 5000, Hungary

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 14, 2022
• Study Start: April 20, 2022
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

HU (8)