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）

NCT05863273 | Completed

• 1 other identifier: OTL-A-2201
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 2

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

Keywords

Apremilast; Otazla; Real World Study

Outcome Measures

Primary Outcomes (1)

• DLQI or PASI improvement

  At week 16，Proportion of patients with DLQI improvement (DLQI ≤5 or DLQI improvement by ≥4 points from baseline) or PASI improvement (PASI \<3)

  16 week

Secondary Outcomes (4)

• PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS

  16 week

• DLQI improvement

  2 week

• DLQI improvement

  6 week

• DLQI improvement

  10 week

Study Arms (1)

Apremilast

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

Drug: Apremilast

Interventions

Apremilast DRUG

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

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with moderate to severe plaque psoriasis

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Hospital of China Medical University: lead
• China-Japan Friendship Hospital: collaborator

Study Sites (2)

the First Hospital of China Medical University

Shenyang, China, 110001, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xinghua Gao, MD

  First Hospital of China Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Hospital of China Medical University

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: May 22, 2023
• Primary Completion: February 10, 2025
• Study Completion: March 10, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)