A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.

N/ANot Yet RecruitingNCT06766552

Second Affiliated Hospital, School of Medicine, Zhejiang University10,000 enrolled

Overview

Ankylosing spondylitis, radiographically negative axial spondyloarthritis, psoriatic arthritis, polymyalgia rheumatica, Takayasu arteritis, giant cell arteritis, non-ocular Behcet's disease, and enthesitis-related arthritis are common diseases in rheumatology. Traditional anti-rheumatic drugs are less effective and have greater side effects than biological agents. At present, there has been no large-scale registration study on rheumatic autoimmune diseases such as spondyloarthritis in China. However, data such as patient characteristics, medication patterns, and patient outcome reports of different rheumatology diseases can often serve as a reference for rheumatology clinicians to reasonably select treatment methods for different patients. Therefore, a large-scale registration study is needed to fill the gap in multi-disease registration studies in rheumatology departments in China.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Ankylosing Spondylitis (AS)Psoriatic Arthritis (PsA)Nr-axSpA Polymyalgia Rheumatica (PMR)Takayasu Arteritis (TAK)Giant Cell Arteritis (GCA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed with rheumatic autoimmune diseases such as ankylosing spondylitis/radiologically negative axial spondyloarthritis/psoriatic arthritis/polymyalgia rheumatica/Takayasu arteritis/giant cell arteritis/ non-ocular Behcet's disease/ enthesitis-related arthritis; 2. Currently receiving or planning to receive fulvezinib treatment; 3. Can follow up according to the doctor's advice; 4. Able to understand and sign the informed consent form, understand the purpose of this study, and voluntarily participate in this study. Exclusion Criteria: 1.Investigator believes will prevent the subject from following and completing the study protocol

Outcomes

Primary Outcomes

European Quality of Life-5 Dimensions Questionnaire （EQ5D） score

European Quality of Life-5 Dimensions Questionnaire （EQ5D） score： The EQ-5D describes five dimensions: mobility, Self-Care, Usual Activities, Pain/comfort, and Anxiety/Depression, each of which contains five levels: No difficulty, a little difficulty, moderate difficulty, serious difficulty, unable to proceed/with very serious difficulty. Using a utility-value conversion table, the EQ-5D index score can be further calculated.

Time frame: From enrollment to the end of treatment at 12 months

Pain VAS score

Pain VAS score (if applicable)：Visual Analogue Scale, The VAS score is indicated by a 10-cm-long straight line, with one end of the line indicating "no pain" (score 0) and the other end indicating "most severe pain" (score 10). Patients marked positions on this line that corresponded to their pain level, and pain was assessed by measuring the distance from the "painless" end to the marked point.