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）

Psoriasis Clinical Trial

Official title:

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）

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05863273
• Other study ID #: OTL-A-2201
• Status: Not yet recruiting
• Start date: May 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: First Hospital of China Medical University
• Contact: Xinghua Gao, MD
• Phone: 13940152467
• Email: gaobarry[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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。

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing
China	the First Hospital of China Medical University	Shenyang

Sponsors (2)

Lead Sponsor	Collaborator
First Hospital of China Medical University	China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS	Absolute values of change from baseline in PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS in subjects at week 16 of treatment	16 week
Secondary	DLQI improvement	Proportion of patients with DLQI score =5 or improvement =4 points from baseline at each visits	2 week
Secondary	DLQI improvement	Proportion of patients with DLQI score =5 or improvement =4 points from baseline at each visits	6 week
Secondary	DLQI improvement	Proportion of patients with DLQI score =5 or improvement =4 points from baseline at each visits	10 week