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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Nr-axSpA, Polymyalgia Rheumatica (PMR), Takayasu Arteritis (TAK), Giant Cell Arteritis (GCA)

Medical subject headings

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: From enrollment to the end of treatment at 12 months

2. 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.

   Measured: From enrollment to the end of treatment at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 Jan 2025
2. Study start30 Jan 2025 (estimated)
3. Primary completion30 Dec 2029 (estimated)
4. Study completion30 Jun 2030 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.