An observational study in Generalized Pustular Psoriasis, sponsored by Chao Ji. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Chao Ji · Observational
The investigators aim to compare the efficacy and safety of secukinumab and ustekinumab in patients with generalized pustular psoriasis (GPP), and to explore the impact of genetic mutation types on clinical efficacy. The main questions the study aims to answer are:
Is there a difference in the effectiveness of secukinumab and ustekinumab in the treatment of GPP? How is the safety of secukinumab and ustekinumab in the treatment of GPP? Does the type of genetic mutation in GPP patients affect the efficacy of secukinumab and ustekinumab? The investigators will compare patients treated with secukinumab to those treated with ustekinumab to see the difference in the effectiveness of the two drugs in treating GPP.
Participants will:
The investigators conducted a 48-week follow-up study on 65 participants who were admitted to the dermatology department of the First Affiliated Hospital of Fujian Medical University for GPP from July 2019 to December 2022. All participants underwent saliva-based genetic testing.
Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) and Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) at week 0, 2, 4, 12, 24, and 48.
Participants were also asked to report all adverse events (AEs) during follow-up.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 65 is below the median of 199 across 407 observational studies indexed under Psoriasis.
Browse Psoriasis studies →Chao Ji is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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This is a retrospective study of adult and pediatric patients with GPP. The investigators obtained data for 65 patients (33 children, 32 adults) who were admitted to the Department of Dermatology in the First Affiliated Hospital of Fujian Medical University because of GPP between July 2019 and Dec 2022. All patients were followed for 48 weeks.
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:
Patients who were severely .
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before treatment, participants underwent routine blood and urine tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver and kidney function tests, tuberculous infection of T cells spot tests, hepatitis B virus marker tests, chest CT scans, etc. After exclusion of relevant contraindications, participants received subcutaneous ustekinumab therapy. During the treatment period, participants received ustekinumab at weeks 0, 4, 16, and every 12 weeks thereafter until week 48. The single dose of ustekinumab was 45 mg for adult subjects weighing ≤ 100 kg, and 90 mg for subjects weighing \> 100 kg. The ustekinumab dosage for pediatric participants was 0.75 mg/kg for participants weighing \< 60 kg; 45 mg for pediatric participants weighing 60 kg to 100 kg; and 90 mg for pediatric participants weighing \> 100 kg.
Drug: After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.
Before treatment, participants underwent routine blood and urine tests, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), liver and kidney function tests, tuberculous infection of T cells spot tests, hepatitis B virus marker tests, chest CT scans, etc. After exclusion of relevant contraindications, participants received subcutaneous secukinumab therapy. During the treatment period, participants received secukinumab at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 48. The secukinumab dosage was 300mg for adult humans. Pediatric participants received a dose based on their weight category (\< 50 kg, ≥ 50 kg): participants weighing \< 50 kg received 75 mg, those weighing ≥ 50 kg received 150 mg.
Drug: After exclusion of relevant contraindications, participants received subcutaneous ustekinumab/secukinumab therapy.
During the treatment period, participants received either ustekinumab at weeks 0, 4, 16, and every 12 weeks thereafter until week 48, or secukinumab at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 48. The dose of ustekinumab/secukinumab was referenced to the dose used for moderate to severe plaque psoriasis. The single dose of ustekinumab was 45 mg for adult subjects weighing ≤ 100 kg, and 90 mg for subjects weighing \> 100 kg. The ustekinumab dosage for pediatric participants was 0.75 mg/kg for participants weighing \< 60 kg; 45 mg for pediatric participants weighing 60 kg to 100 kg; and 90 mg for pediatric participants weighing \> 100 kg. The secukinumab dosage was 300mg for adult humans. Pediatric participants received a dose based on their weight category ( \<50 kg, ≥50 kg): participants weighing \< 50 kg received 75 mg, those weighing ≥ 50 kg received 150 mg.
Also known as: The investigators collected participants' saliva for genotyping.
To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPASI.
Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Area and Severity Index (GPPASI) at week 0, 2, 4, 12, 24, and 48. GPPASI provided a numeric scoring system to assess patient's overall disease state of GPP, ranging from 0 to 72, with higher scores indicating more severe conditions. Clinical efficacy was evaluated by GPPASI -50, -75, -90, and -100 responses at each time point.
Time frame: 48 weeks
To compare the clinical efficacy difference between ustekinumab and secukinumab in the treatment of GPP through evaluation of GPPGA.
Efficacy analyses were performed based on the scores of Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) at week 0, 2, 4, 12, 24, and 48. The investigator scored the erythema, pustules, and scale of all GPP lesions from 0 to 4 using GPPGA. Each component was graded separately, and the average was calculated. The final GPPGA was determined by this composite score.
Time frame: 48 weeks
By saliva-based genetic testing, analyze the mutation rates of common mutation gene sites in GPP.
To analyze whether gene mutations cause different responses to ustekinumab and secukinumab in GPP patients.
Time frame: 48 weeks
Analyzing the incidence of adverse reactions to ustekinumab and secukinumab in the treatment of GPP.
During the follow-up period, participants are requested to report all adverse reactions experienced since their last visit, such as rash, diarrhea, infections, etc., and record the type, onset time, severity, duration, triggering, and relieving factors of the adverse reactions.
Time frame: 48 weeks
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Chao Ji