A Study to Assess the Change in Disease State in Adult Participants Being Treated With Oral Upadacitinib Tablets in Participants With Oligo- or Poly-artIcular Psoriatic Arthritis

AbbVie394 enrolled

Overview

Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by the body's immune system mistakenly attacking healthy joint tissue causing inflammation, joint damage, disability, and a reduced life expectancy. The main objective of this study is to characterize attainment of minimal disease activity (MDA) at week 24 under continuous treatment with upadacitinib in participants with oligo- or polyarticular PsA as part of real-world practice. Upadacitinib is a drug approved for the treatment of Psoriatic arthritis (PsA) in Germany and Canada. Approximately 380 adult participants with PsA at multiple sites in Germany and Canada. Participants will receive oral Upadacitinib tablets per current local label, according to local standard of care and international guidelines. There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by questionnaire.

Study Type

OBSERVATIONAL

Enrollment

394

Conditions

Psoriatic Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of active Psoriatic Arthritis (PsA) upon judgment of the treating physician. * Swollen joint count (SJC) \>= 1 out of 66 joints. * Decision on the treatment with Upadacitinib was made prior to any decision to approach the participant to participate in this study. Exclusion Criteria: * Cannot be treated with Upadacitinib according to the local Upadacitinib Summary of Product Characteristics (SmPC). * Prior treatment with Upadacitinib. * Currently participating in interventional research or within the last 30 days.

Locations (93)

Dr. Jonathan D. Chan Inc. /ID# 241611

Vancouver, British Columbia, Canada

Manitoba Clinic /ID# 234148

Winnipeg, Manitoba, Canada

The Waterside Clinic /ID# 234146

Barrie, Ontario, Canada

Dr. Chrisostomos Kouroukis & Dr. Pauline Boulos MPC /ID# 233565

Dundas, Ontario, Canada

Arthur Karasik Medicine Professional Corporation /ID# 234147

Etobicoke, Ontario, Canada

Outcomes

Primary Outcomes

Percentage of Participants Receiving Upadacitinib who Attain Minimal Disease Activity (MDA)

MDA will be determined based on participants fulfilling 5 of 7 outcome measures: tender joint count 68 (TJC68) \<= 1, swollen joint count (SJC66) ≤ 1, body surface area (BSA) \<= 3%; Patient's Assessment of Pain numeric rating scale (NRS) \<= 1.5, Patient's Global Assessment of Disease Activity (PtGA) NRS \<= 2.0, Health Assessment Questionnaire Disability Index (HAQ-DI) \<= 0.5, tender entheseal points \<= 1.

Time frame: At Week 24

Secondary Outcomes

Percentage of Participants Maintaining MDA Under Upadacitinib Treatment, in Participants who had Achieved MDA at Week 24

MDA will be determined based on participants fulfilling 5 of 7 outcome measures: TJC68 \<= 1, SJC66 ≤ 1, BSA \<= 3%; Patient's Assessment of Pain NRS \<= 1.5, PtGA NRS \<= 2.0, HAQ-DI \<= 0.5, tender entheseal points \<= 1.

Time frame: At Week 48

Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Pain in Neck, Back or Hip)

The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem).