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Not yet recruitingNCT06766552V-MIRACLEUpdated Jan 9, 2025

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

An observational study in Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) and Nr-axSpA, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ankylosing Spondylitis (AS)
  • Psoriatic Arthritis (PsA)
  • Nr-axSpA
  • Polymyalgia Rheumatica (PMR)
  • Takayasu Arteritis (TAK)
  • Giant Cell Arteritis (GCA)
  • Behcet's Disease
  • Enthesitis-related Arthritis
03

In context

Spondylitis, Ankylosing

531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 202 across 214 observational studies indexed under Spondylitis, Ankylosing.

Browse Spondylitis, Ankylosing studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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;

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosed with rheumatic 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 form, understand the purpose of this study, and voluntarily participate in this study.

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06766552
Responsible party
Sponsor
First posted
Jan 9, 2025
Start date
Jan 30, 2025 (estimated)
Primary completion
Dec 30, 2029 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jan 9, 2025

Study contacts

Huaxiang wu
Contact
wuhx8855@sina.com
+8613757118395

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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