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

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.

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Key information

Conditions

Ankylosing Spondylitis (AS) Ankylosis Aortic Arch Syndromes Aortic Diseases Arteritis Arthritis Arthritis, Juvenile Arthritis, Psoriatic Autoimmune Diseases Autoimmune Diseases of the Nervous System Axial Spondyloarthritis Behcet's Disease Bone Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Connective Tissue Diseases Enthesitis-related Arthritis Giant Cell Arteritis Giant Cell Arteritis (GCA) Immune System Diseases Joint Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Non-Radiographic Axial Spondyloarthritis Nr-axSpA Polymyalgia Rheumatica Polymyalgia Rheumatica (PMR) Psoriasis Psoriatic Arthritis (PsA) Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin Diseases, Vascular Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Takayasu Arteritis Takayasu Arteritis (TAK) Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China

Location contact

Huaxiang Wu

CONTACT

[email protected]

+8613757118395

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

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.
Pain VAS score

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huaxiang wu

CONTACT

[email protected]

+8613757118395

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: V-MIRACLE

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2030
First posted: Jan 9, 2025
Registry last updated: Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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