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

NCT06766552 | Not Yet Recruiting

• 1 other identifier: z220241396
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

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

  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.

  From enrollment to the end of treatment at 12 months

• Pain VAS score

  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.

  From enrollment to the end of treatment at 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

• 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.

You may not qualify if:

• Investigator believes will prevent the subject from following and completing the study protocol

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Arthritis, Psoriatic; Non-Radiographic Axial Spondyloarthritis; Polymyalgia Rheumatica; Takayasu Arteritis; Giant Cell Arteritis; Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Diseases; Rheumatic Diseases; Connective Tissue Diseases; Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Huaxiang wu

CONTACT

+8613757118395; wuhx8855@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 9, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 9, 2025

Record last verified: 2024-12

Locations

CN (1)