Clinical trial NCT06766552: A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.
Official title: A Multicenter Registry Study Assessing Patient Reported Outcome, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ankylosing Spondylitis (AS)
Psoriatic Arthritis (PsA)
Nr-axSpA
Polymyalgia Rheumatica (PMR)
Takayasu Arteritis (TAK)
Giant Cell Arteritis (GCA)
Behcet&#39;s Disease
Enthesitis-related Arthritis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients have been 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, and enthesitis-related arthritis;

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: European Quality of Life-5 Dimensions Questionnaire （EQ5D） score
timeFrame: From enrollment to the end of treatment at 12 months
measure: Pain VAS score
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: HangZhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
Study officials:
References: