A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment. (NCT06270225) | Clinical Trial Compass
UnknownPhase 2
A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.
China157 participantsStarted 2024-03-30
Plain-language summary
The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must be 18 Years to 75 Years, both male and female.
* BMI ≤40 kg/m2.
* Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis.
* ≥2 acute gout flares within 1 year prior to screening.
* Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration.
Exclusion Criteria:
* Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc.
* Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
* Presence of severe renal function impairment.
* Intolerance of subcutaneous injection.
* Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment.
* Live vaccinations within 8 weeks prior to the start of the study.
* Use of forbidden therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.