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)

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05863273
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

First Hospital of China Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Xinghua Gao, MD
Principal Investigator Affiliation First Hospital of China Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

: Apremilast

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

Interventions

Drug: - Apremilast

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

China-Japan Friendship Hospital, Beijing, China

Status

Address

China-Japan Friendship Hospital

Beijing, ,

Site Contact

Yong Cui, MD

wuhucuiyong@vip.163.com

15701625913

Shenyang, China

Status

Address

the First Hospital of China Medical University

Shenyang, , 110001

Site Contact

xinghua gao

gaobarry@hotmail.com

13940152467

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