A Phase 3 interventional study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg and Placebo in Acute Gout, sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (part of 3SBio Inc.) · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the efficacy and safety of recombinant anti-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.
Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 500 is above the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. is the lead sponsor of 59 studies on the registry; 22 are open to participants now.
First submitted after Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. became part of 3SBio Inc..
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.
Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg · Other: Placebo
Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1.
Drug: Compound Betamethasone Injection · Other: Placebo
one s.c. injection of SSGJ-613 once, on Day 1.
Also known as: SSGJ-613 200 mg
Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.
Also known as: 0.9% sodium chloride injection
1 mL i.m. once on Day 1
Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.
Also known as: PBO
The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The change in pain intensity from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Time frame: 72 hours post-dose
Time to First New Flare
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares within 12 weeks after the first administration of each group, as well as the event incidence and 95% CI at 12 weeks.
Time frame: 12 weeks
The Change in Pain Intensity in the Target Joint From Baseline to 6, 24, 48 Hours and 7 Days Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
The change in pain intensity from baseline to 6, 12, 48 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Time frame: At 6, 24, 48 hours and 7 Days post-dose
The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint after study drug administration
The time to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).
Time frame: Up to 48 weeks
The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration
The time to complete pain remission in Pain intensity from baseline as measured by a 5-point Likert scale for each treatment group, is estimated using the Kaplan Meier method. Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.
Time frame: Up to 48 weeks
Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration
Participants scored their pain intensity in the target joint on a 5-point Likert scale: None, mild, moderate, severe, extremely severe.
Time frame: 12 weeks
Time to first use of Rescue Medication
The Kaplan Meier method was used to estimate the median time and 95% CI of the first use of Rescue Medication.
Time frame: Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period
Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication
Time frame: 12 weeks, 24 weeks, 48 weeks
Likert scores for target joint pain
Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme).
Time frame: 7 days, 12 weeks, 24 weeks
Time to First New Flare
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares after the first administration of each group, as well as the event incidence and 95% CI.
Time frame: 24 weeks, 48 weeks
Percentage of Participants with at least 1 new gout flare
Time frame: 12 weeks, 24 weeks, 48 weeks
Number of new gout flares
Time frame: 12 weeks, 24 weeks, 48 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2023; primary completion for Dec 2024, 12 months later.
Of 21 phase 3 interventional studies under Gout, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 25. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. →