Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients with Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）

First Hospital of China Medical University2 sites in 1 country360 target enrollmentMay 22, 2023

ConditionsPsoriasis

InterventionsApremilast

DrugsApremilast

Overview

Phase: Not Applicable
Intervention: Apremilast
Conditions: Psoriasis
Sponsor: First Hospital of China Medical University
Enrollment: 360
Locations: 2
Primary Endpoint: DLQI or PASI improvement
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, one-arm, prospective, observational study，intended to assess evaluation of efficacy and safety of Apremilast in Chinese patients with moderate-to-severe plaque psoriasis。During this study, it is expected to collect data at at baseline and weeks 2, 6, 10, 16, and 20 after treatment。

Registry

clinicaltrials.gov

Start Date

May 22, 2023

End Date

March 10, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

First Hospital of China Medical University

Responsible Party

Principal Investigator

Xing hua Gao

First Hospital of China Medical University

Eligibility Criteria

Inclusion Criteria

•Males or females, ≥ 18 years of age at the time of signing the informed consent document；
•Patients with moderate-to-severe plaque psoriasis：Simultaneously meet (1)and (2): (1)PASI≥ 3；(2) DLQI ≥ 6；
•Subject is a candidate for phototherapy and/or systemic therapy
•Patients who wish to be treated with Apremilast and sign the informed consent

Exclusion Criteria

•Allergy to Apremilast or any component of the study drug；
•Use of phototherapy within 4 weeks prior to randomization；Use of systemic drugs or biologic agents within 4 half-life periods prior to randomization；Patients with inadequate response or intolerance to previous systemic therapy do not need to consider drug washout；
•Currently using potent cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, etc.)；
•History of substance abuse, suicide attempts, or mental illness；
•Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period；
•Pustular type, erythroderma type and other psoriasis patients；
•Other circumstances that investigators don't consider appropriate to include.