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

A Multicenter Registry Study Assessing Patient Reported Outcome, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06766552
Acronym
V-MIRACLE
Enrollment
10000
Registered
2025-01-09
Start date
2025-01-30
Completion date
2030-06-30
Last updated
2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis (AS), Behcet's Disease, Enthesitis-related Arthritis, Giant Cell Arteritis (GCA), Nr-axSpA, Polymyalgia Rheumatica (PMR), Psoriatic Arthritis (PsA), Takayasu Arteritis (TAK)

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
European Quality of Life-5 Dimensions Questionnaire (EQ5D) scoreFrom enrollment to the end of treatment at 12 monthsEuropean 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.
Pain VAS scoreFrom enrollment to the end of treatment at 12 monthsPain 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.

Countries

China

Contacts

Primary ContactHuaxiang wu
wuhx8855@sina.com+8613757118395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026