A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Nr-axSpA, Polymyalgia Rheumatica (PMR). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Registry Study Assessing Patient Reported Outcome, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.
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.
Primary outcome measures
- European Quality of Life-5 Dimensions Questionnaire （EQ5D） score [Time frame: From enrollment to the end of treatment at 12 months]
- Pain VAS score [Time frame: From enrollment to the end of treatment at 12 months]
Eligibility criteria
Inclusion criteria
- 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;
- Currently receiving or planning to receive fulvezinib treatment;
- Can follow up according to the doctor's advice;
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT06766552 · z220241396