A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With Gener… (NCT06766552) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.
China10,000 participantsStarted 2025-01-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
.Investigator believes will prevent the subject from following and completing the study protocol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This registry study is tracking real-world use of vunakizumab across several rheumatic diseases including my condition — can you explain what a registry study means in terms of whether I'd be receiving an experimental treatment or simply being observed while on a medication you might already prescribe?
2Since the trial is not yet recruiting, how long might it realistically be before it opens, and does waiting to see if I qualify affect my current treatment options or timeline?
3The study is measuring quality of life and pain scores using patient-reported questionnaires — does participating mostly mean filling out forms about how I feel, and what kind of time commitment or clinic visits would that involve for someone in my situation?
4Given that vunakizumab is being studied across very different conditions like Ankylosing Spondylitis, Giant Cell Arteritis, and Behcet's Disease, how confident are you that the evidence for my specific diagnosis is strong enough to consider this medication, whether inside or outside this registry?
5Are there established standard-of-care treatments for my condition that you'd recommend I try first before considering enrollment in this observational registry, or would participating alongside my current treatment plan even be an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
European Quality of Life-5 Dimensions Questionnaire （EQ5D） score
Timeframe: From enrollment to the end of treatment at 12 months
2
Pain VAS score
Timeframe: From enrollment to the end of treatment at 12 months
Trial details
NCT IDNCT06766552
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University