Psoriasis vulgaris psoriasis
Conditions
Interventions
1)Patients with Psoriasis vulgaris undergoing treatment with biologicals.
(1) Treatment start (0 week) - End of treatment
a-1. Patients undergoing treatment with Stelara.
Continuation of the dose at e
Sponsors
Morita Akimichi
Miyachi Yoshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Treatment preference questionnaire (patient questionnaire) (1)Patients with Psoriasis vulgaris undergoing treatment with biologicals(a) a-1. Patients undergoing treatment with Stelara. Patients undergoing treatment with 45 mg or 90 mg once every 12 weeks However, patients who have undergone a change in dosage within the past 12 weeks are excluded. a-2. Patients receiving biologic therapy other than Stelara i)Patients who are at least 18 years of age when consent is obtained. ii)Patients who have maintained remission for more than 3 months. iii)Patients who provided written consent to participate in the study after receiving a written explanation of the study's content. (2)Patients with psoriasis vulgaris who have no prior experience with biologicals (b) i)Patients who are at least 18 years of age when consent is obtained. ii)Patients who meet any of the following criteria -Patients who have not achieved sufficient efficacy with existing systemic therapies, including phototherapy (excluding biologic agents), and have rashes covering more than 10% of their body surface area. -Patients with refractory rashes or joint symptoms. iii): Patients who provided written consent to participate in the study after receiving a written explanation of the study's content. 2)Evaluation of Usefulness (1)Patients with Psoriasis vulgaris undergoing treatment with biologicals(a) a-1. Patients undergoing treatment with Stelara. Patients undergoing treatment with 45 mg or 90 mg once every 12 weeks However, patients who have undergone a change in dosage within the past 12 weeks are excluded. a-2. Patients on treatment with other biologicals except Stelara. i)Patients preferring treatment with ustekinumab BS in the Treatment Preference Questionnaire (patient questionnaire) ii)Patients who have maintained remission* for more than 3 months. *remission: meeting PASI<3 or BSA<3,and DLQI<=1. In cases of concomitant psoriatic arthritis: meeting SJC=0 and TJC=0 and HAQ-DI<=0.55. iii)Patients who have given written re-consent to participate in the study (evaluation of usefulness) after the details of the study have been explained to them again in writing. (2)Patients with psoriasis vulgaris who have no prior experience with biologicals (b) i)Patients preferring treatment with ustekinumab BS in the Treatment Preference Questionnaire (patient questionnaire) ii)Patients who meet any of the following criteria -Patients who have not achieved sufficient efficacy with existing systemic therapies, including phototherapy (excluding biologic agents), and have rashes covering more than 10% of their body surface area. -Patients with refractory rashes** or joint symptoms. **Patients with refractory rashes in difficult-to-treat areas (such as the scalp, palms, soles, genitals, etc.) and a PASI score of 5 or higher. iii)Patients who have given written re-consent to participate in the study (evaluation of usefulness) after the details of the study have been re-explained to them again in writing.
Exclusion criteria
Exclusion criteria: 1) Patients receiving the investigational drug (ustekinumab biosimilar) 2) Patients with serious infections and/or active tuberculosis 3) Patients with a previous history of hypersensitivity to any ingredient of the investigational drug 4) Patients who have been treated with the investigational drug in the past but were not able to continue treatment due to safety or other reasons 5) Patients who are pregnant, may become pregnant, or wish to become pregnant. 6) Patients who are currently enrolled in a clinical trial or an intervention study and patients who participated in a clinical trial during the 6 months prior to obtaining consent for this study. 7) Patients considered ineligible by the principal investigator or subinvestigator 8) Patients who have had a change in dosage of Stelara within the past 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate and record safety according to the following guidelines. Regarding Safety endpoints, collect all clinically problematic adverse events that occur in the subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Treatment preference questionnaire -The proportion of patients who prefer treatment with ustekinumab BS -Current treatment satisfaction and preference for biosimilars. 2)Evaluation of Efficacy -Changes and Rate of Change in PASI Score -Maintenance rate of PASI score during switchover(Patients with psoriasis vulgaris undergoing treatment with biologicals) - Changes in BSA, PGA, sPGA, NAPSI, ACR (SJC and TJC), and HAQ-DI -Presence of enthesitis -Changes in QOL : DLQI -Achievement rates of PASI75, PASI90, and PASI100 from weeks 24 to 28 of treatment. -Changes in concomitant medications | — |
Contacts
Public ContactMotohiro Honda
EBC&M LLC
Outcome results
None listed