Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 1713 for:    psoriasis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03236870
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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.

Condition or disease
Psoriasis

Layout table for study information
Study Type : Observational
Estimated Enrollment : 181 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postmarketing Observational Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

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



Primary Outcome Measures :
  1. Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score [ Time Frame: At Week 12 ]
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.


Secondary Outcome Measures :
  1. Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: From Week 0 to Week 12 ]
    The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with moderate to severe plaque psoriasis in China
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236870


Contacts
Layout table for location contacts
Contact: Haiyan Chen 15618405385 Haiyan.chen@abbvie.com

Locations
Layout table for location information
China, Anhui
Guangzhou 1st Muni People Hosp /ID# 208858 Completed
Guangzhou, Anhui, China, 510030
The First Affiliated Hospital /ID# 171398 Recruiting
Hefei, Anhui, China, 230031
AbbVie China /ID# 151567 Recruiting
Shanghai, Anhui, China
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 169833 Recruiting
Shanghai, Shanghai, China, 200025
China, Xinjiang
Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183 Active, not recruiting
Wulumuqi, Xinjiang, China, 830099
China, Zhejiang
The Second Affiliated Hospital /ID# 169842 Recruiting
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital /ID# 169834 Recruiting
Hangzhou, Zhejiang, China, 310016
China
Peking University 3rd Hospital /ID# 213443 Recruiting
Beijing, China, 100191
Dermatology Hospital of southe /ID# 169830 Recruiting
Guangzhou, China, 510018
2nd Aff. Hosp Harbin Med Univ /ID# 169827 Not yet recruiting
Haerbin, China, 150086
Shandong Provincial Hospital /ID# 169841 Completed
Jinan, China, 250021
The Tenth People's Hospital of /ID# 169831 Active, not recruiting
Shanghai, China, 200072
The First Affiliated Hospital of Shantou University Medical College /ID# 209260 Recruiting
Shantou, China, 515000
The 7th People's Hospital of Shenyang /ID# 169829 Active, not recruiting
Shenyang, China, 110003
Shenzhen Hospital of Southern /ID# 169828 Recruiting
Shenzhen, China, 518110
Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201 Recruiting
Tianjin, China, 300381
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Additional Information:
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03236870     History of Changes
Other Study ID Numbers: P15-986
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
psoriasis
effectiveness
safety
adalimumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents