Ankylosing Spondylitis (AS)V-MIRACLENCT06766552
A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.
An observational study of Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Nr-axSpA
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2025to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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;
Who may be able to join
- 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.
Who cannot join
- 1.Investigator believes will prevent the subject from following and completing the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Zhejiang University
Hangzhou
Huaxiang Wu, +8613757118395, wuhx8855@sina.com
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.
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)
- 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.
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
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.
- First posted9 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion30 Dec 2029 (estimated)
- 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766552
- Sponsor's protocol ID
- z220241396
- Acronym
- V-MIRACLE
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Registry Study Assessing Patient Reported Outcome, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.
- ClinicalTrials.gov ID
- NCT06766552
- Acronym / sponsor ID
- V-MIRACLE / z220241396
- Conditions
- Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Nr-axSpA, Polymyalgia Rheumatica (PMR), Takayasu Arteritis (TAK), Giant Cell Arteritis (GCA)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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;
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1.Investigator believes will prevent the subject from following and completing the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaxiang wu (+8613757118395, wuhx8855@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Quality of Life-5 Dimensions Questionnaire （EQ5D） score (time frame: From enrollment to the end of treatment at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.