An Observational Study to Assess the Real-World Effectiveness of Upadacitinib in Adult Participants With Rheumatoid Arthritis

NCT05170646 | Completed

• 1 other identifier: P20-235
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 15

Brief Summary

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 will assess the clinical and patient-reported outcomes with upadacitinib in adult participants with moderate-to-severe RA in a real-world setting. Upadacitinib is an approved drug for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. Adult participants with moderate-to-severe RA will be enrolled. Around 150 participants will be enrolled in the study in multiple sites in the United Kingdom. Participants will receive upadacitinib per their physician's usual prescription. Individual data will be collected for 6 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.

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) Clinical Remission

  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. Clinical remission is defined as a DAS28 CRP \<2.6.

  6 Months

Secondary Outcomes (34)

• Percentage of Participants Achieving a Moderate European League Against Rheumatism (EULAR) Response

  6 Months

• Percentage of Participants Achieving DAS28 CRP Clinical Remission

  3 Months

• Percentage of Participants Achieving DAS28 CRP Low Disease Activity

  3 Months

• Percentage of Participants Achieving DAS28 CRP Low Disease Activity

  6 Months

• Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission

  3 Months

Study Arms (1)

Participants treated with upadacitinib

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:

• American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) confirmed diagnosis of rheumatoid arthritis (RA).
• Moderate RA (defined by National Institute for Health and Care Excellence \[NICE\] as 28-joint Disease Activity Score \[DAS28\] C-reactive protein \[CRP\] \>3.2 and ≤5.1) or severe RA (defined by NICE as DAS28 CRP \>5.1) at the time of enrollment.
• Prescribed upadacitinib in line with marketing authorization.
• Decision to treat with upadacitinib has been made independently and prior to enrolment in the study.
• Able to read and understand English.
• Willing and able to participate in the collection of patient-reported data via mobile app.

You may not qualify if:

• First dose of upadacitinib received prior to enrollment in the study (same day permitted) or more than 28 days after enrolment into the study.
• Previously received \>4 biologic disease-modifying antirheumatic drugs (bDMARD) (1 switch to a biosimilar for non-clinical reasons is allowed for each bDMARD received) or any Janus kinase (JAK) inhibitor for the treatment of RA.
• In the opinion of the treating clinician, participant symptoms are predominately being driven by fibromyalgia or unrelated pain component instead of underlying inflammatory disease.
• Participation in any interventional clinical trial within the 3 months prior to initiation or at any point during the study observation period.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (15)

University Hospitals of Morecambe Bay NHS Foundation Trust /ID# 242376

Kendal, Cumbria, LA9 7RG, United Kingdom

Location

Leicester Royal Infirmary /ID# 244674

Leicester, England, LE1 5WW, United Kingdom

Location

Medway NHS Foundation Trust /ID# 244673

Gillingham, Kent, ME7 5NY, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust /ID# 251704

London, London, City of, SE1 9RT, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 251700

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Northampton General Hospital NHS Trust /ID# 251710

Northampton, Northamptonshire, NN1 5BD, United Kingdom

Location

Royal United Hospitals Bath /ID# 251707

Bath, BA1 3NG, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust /ID# 251706

Cambridge, CB2 0QQ, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust /ID# 251701

Liverpool, L7 8XP, United Kingdom

Location

King's College Hospital NHS Foundation Trust /ID# 251705

London, SE5 9RS, United Kingdom

Location

Western Health and Social Care Trust /ID# 251702

Londonderry, BT47 6SB, United Kingdom

Location

Luton and Dunstable Hospital NHS Foundation Trust /ID# 251699

Luton, LU4 0DZ, United Kingdom

Location

Aneurin Bevan University Health Board /ID# 251703

Newport, NP19 7PH, United Kingdom

Location

The Royal Wolverhampton NHS Trust /ID# 251708

Wolverhampton, WV10 0QP, United Kingdom

Location

York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 244672

York, YO31 8HE, United Kingdom

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: November 16, 2021
• First Posted: December 28, 2021
• Study Start: March 14, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

GB (15)