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）

NCT ID: NCT05863273

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2025-03-10

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。

Conditions

Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Apremilast

Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.

Apremilast

Intervention Type: DRUG

Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.

Interventions

Apremilast

Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xing hua Gao

First Hospital of China Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinghua Gao, MD

Role: STUDY_DIRECTOR

First Hospital of China Medical University

Locations

the First Hospital of China Medical University

Shenyang, China, China

China-Japan Friendship Hospital

Beijing, , China

Countries

China

Other Identifiers

OTL-A-2201

Identifier Type: -

Identifier Source: org_study_id