Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein in the Treatment of Acute Gout (NCT05925166) | Clinical Trial Compass
CompletedNot Applicable
Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ Fusion Protein in the Treatment of Acute Gout
China26 participantsStarted 2020-09-01
Plain-language summary
The goal of this study is to evaluate the efficacy and safety of Recombinant Human Tumor necrosis Factor-α Receptor Ⅱ Fusion Protein （rhTNFR-Fc）in the treatment of patients with acute Gout.
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
. Can voluntarily sign the informed consent, and voluntarily cooperate with the completion of the experiment according to the plan;
. 18 years old ≤ 75 years old, male and female;
. Body mass index (BMI) ≤ 40 kg/m2;
. Patients diagnosed with gout according to the American College of Rheumatology (ACR) 2015 gout classification criteria;
. The current acute gout attack occurred within 4 days before the screening period;
. The pain degree of target joint during the screening period was VAS≥ 5 mm (VAS 0-10mm);
. We are willing to follow the protocol of uric acid lowering therapy (ULT) during the study period and meet the following conditions One:
Exclusion criteria
. There is a history of allergic reaction to the investigational drug or similar drugs;
. People who have received any of the following drugs or treatments:
. Use of NASIADs within 24 hours prior to enrollment;
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.