A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China

Study Purpose

The objective of this non-interventional, observational study is to assess the effectiveness and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in real world clinical practice in China.

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 - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participant who is in compliance with eligibility for adalimumab based on the local label.
  • - Moderate to severe plaque psoriasis patients eligible to use adalimumab according to the local label without any contraindication.
  • - Patients have signed the authorization (or informed consent where applicable) to disclose and use personal health information after been prescribed with adalimumab.

Exclusion Criteria:

  • - Patients who are pregnant or breast feeding at enrolment or wish to become pregnant during the following adalimumab treatment and within 150 days since adalimumab discontinuation.
  • - Patients in any psoriasis related clinical trial at the time of enrolment, at baseline or at any point during the study follow-up.
  • - Patients with active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) as well as moderate to severe cardiac insufficiency.
  • - Patients with difficulties for adequately reading, understanding and completing patient questionnaires.

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.

NCT03236870
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.

AbbVie
Principal Investigator

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

AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

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

Industry
Overall Status Recruiting
Countries China
Conditions

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

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

: Participants with moderate to severe plaque psoriasis in China

Participants with moderate to severe plaque psoriasis in China receiving adalimumab in daily clinical practice.

Interventions

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

Guangzhou, Anhui, China

Status

Completed

Address

Guangzhou 1st Muni People Hosp /ID# 208858

Guangzhou, Anhui, 510030

Hefei, Anhui, China

Status

Recruiting

Address

The First Affiliated Hospital /ID# 171398

Hefei, Anhui, 230031

AbbVie China /ID# 151567, Shanghai, Anhui, China

Status

Recruiting

Address

AbbVie China /ID# 151567

Shanghai, Anhui,

Shanghai, Shanghai, China

Status

Recruiting

Address

Ruijin Hospital, Shanghai Jiaotong /ID# 169833

Shanghai, Shanghai, 200025

Wulumuqi, Xinjiang, China

Status

Active, not recruiting

Address

Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183

Wulumuqi, Xinjiang, 830099

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The Second Affiliated Hospital /ID# 169842

Hangzhou, Zhejiang, 310009

Sir Run Run Shaw Hospital /ID# 169834, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Sir Run Run Shaw Hospital /ID# 169834

Hangzhou, Zhejiang, 310016

Beijing, China

Status

Recruiting

Address

Peking University 3rd Hospital /ID# 213443

Beijing, , 100191

Guangzhou, China

Status

Recruiting

Address

Dermatology Hospital of southe /ID# 169830

Guangzhou, , 510018

Haerbin, China

Status

Not yet recruiting

Address

2nd Aff. Hosp Harbin Med Univ /ID# 169827

Haerbin, , 150086

Shandong Provincial Hospital /ID# 169841, Jinan, China

Status

Completed

Address

Shandong Provincial Hospital /ID# 169841

Jinan, , 250021

Shanghai, China

Status

Active, not recruiting

Address

The Tenth People's Hospital of /ID# 169831

Shanghai, , 200072

Shantou, China

Status

Recruiting

Address

The First Affiliated Hospital of Shantou University Medical College /ID# 209260

Shantou, , 515000

Shenyang, China

Status

Active, not recruiting

Address

The 7th People's Hospital of Shenyang /ID# 169829

Shenyang, , 110003

Shenzhen, China

Status

Recruiting

Address

Shenzhen Hospital of Southern /ID# 169828

Shenzhen, , 518110

Tianjin, China

Status

Recruiting

Address

Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201

Tianjin, , 300381

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