Clinical Study of Stage IV Psoriasis in Children With Geleli (NCT05803187) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study of Stage IV Psoriasis in Children With Geleli
China80 participantsStarted 2023-04-05
Plain-language summary
This study is a multicenter, prospective, observational phase IV clinical study. A total of 80 children and adolescents with severe plaque psoriasis were included in the study. The study is expected to last for 24 weeks (169 days). This study will evaluate the efficacy and safety of Valerie Ā® (Adalimumab Injection) in Chinese children over 4 years old and adolescents with severe plaque psoriasis.
Who can participate
Age range4 Years ā 18 Years
SexALL
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Inclusion criteria
ā. ) Patients and / or patient guardians voluntarily participated in the study and signed informed consent
ā. )Age ā„ 4 years and \< 18 years, male or female
ā. ) The weight of patients should be 15 kg or more
ā. ) Patients diagnosed with plaque psoriasis for at least 6 months ; at the same time, the researchers clarified the diagnosis of psoriasis
ā. ) Patients with poor efficacy or unsuitable for local treatment and / or phototherapy
ā. ) For patients with severe plaque psoriasis, the definition should meet one of the following conditions : Psoriasis static clinician overall assessment PGA score ā„ 4 points The body surface area of psoriatic lesions was BSA \> 10 %. Psoriasis area and severity index PASI \> 12 Children 's skin disease quality of life index ( CDLQI ) score \> 10 points.
Exclusion criteria
ā. A history of severe allergies or allergic reactions to monoclonal antibodies
ā. Active infectious diseases ( including tuberculosis, hepatitis B, AIDS, syphilis, etc. )
ā. Conform to any of the following criteria associated with latent or active TB infection :
ā. Two pairs of hepatitis B surface antigen ( HBsAg ) were positive in screening. Or HBsAg negative, HBcAb positive and HBV-DNA positive.
ā. There are serious, progressive or uncontrollable kidney, liver, blood, gastrointestinal, lung, heart blood. Tube, nerve or brain disease symptoms.
ā. Patients received anti-tumor necrosis factor ( TNF ) or other biological agents with potential therapeutic effects on psoriasis within the previous 12 weeks.
ā. Patients received intravenous anti-infective therapy within 30 days or oral anti-infective therapy within 14 days.
ā. Local glucocorticoids, vitamin D derivatives, retinoic acid, calcineurin inhibitors ( TCI ) and other topical preparations with pharmacologically active ingredients were received within 7 days.