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）

China Medical University

Status

Completed

Conditions

Psoriasis

Treatments

Drug: Apremilast

Study type

Observational

Funder types

Other

Identifiers

NCT05863273

OTL-A-2201

Details and patient eligibility

About

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。

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.