PsoriasisADAPTNCT03236870
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
An observational study of Psoriasis, run by AbbVie at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Psoriasis
- How many people
- 181 participants
- Where
- 15 sitesChina
- Study dates
- 8 Sep 2017to 25 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with moderate to severe plaque psoriasis in China
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Peking University 3rd Hospital /ID# 213443
Beijing, 100191
Guangzhou 1st Muni People Hosp /ID# 208858
Guangzhou, Guangdong, 510030
Dermatology Hospital of southe /ID# 169830
Guangzhou, 510018
2nd Aff. Hosp Harbin Med Univ /ID# 169827
Haerbin, 150086
The Second Affiliated Hospital /ID# 169842
Hangzhou, Zhejiang, 310009
The First Affiliated Hospital /ID# 171398
Hefei, Anhui, 230031
Sir Run Run Shaw Hospital /ID# 169834
Jianggan Hangzhou, Zhejiang, 310018
Shandong Provincial Hospital /ID# 169841
Jinan, 250021
Ruijin Hospital, Shanghai Jiaotong /ID# 169833
Shanghai, Shanghai Municipality, 200025
The Tenth People's Hospital of /ID# 169831
Shanghai, 200072
The First Affiliated Hospital of Shantou University Medical College /ID# 209260
Shantou, 515000
The 7th People's Hospital of Shenyang /ID# 169829
Shenyang, 110003
Shenzhen Hospital of Southern /ID# 169828
Shenzhen, 518110
Jing Tai Tianjin Hospital Co.,Ltd /ID# 208201
Tianjin, 300381
Traditional Chinese Medical Hospital of xinjiang uygur autonomous region /ID# 209183
Ürümqi, Xinjiang, 830099
About this study
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
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.
- Conditions
- Psoriasis
- Keywords
- psoriasis, effectiveness, safety, adalimumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with moderate to severe plaque psoriasis in China | Participants with moderate to severe plaque psoriasis in China receiving adalimumab in daily clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving at least a 75% reduction in Psoriasis Area Severity Index (PASI) relative to the baseline PASI score
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.
Measured: At Week 12
Secondary outcomes (1)
Change from Baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a self administered short, simple and practical dermatology-specific quality of life (QoL) questionnaire.
Measured: From Week 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start8 Sep 2017
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236870
- Sponsor's protocol ID
- P15-986
- Acronym
- ADAPT
- Status last verified
- Oct 2021
- First submitted
- 31 Jul 2017
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03236870
- Acronym / sponsor ID
- ADAPT / P15-986
- Conditions
- Psoriasis
- Keywords
- psoriasis, effectiveness, safety, adalimumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with moderate to severe plaque psoriasis in China | – | –Participants with moderate to severe plaque psoriasis in China receiving adalimumab in daily clinical practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moderate to severe plaque psoriasis in China
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Change from Baseline in Dermatology Life Quality Index (DLQI)
Time frame: From Week 0 to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by AbbVie at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.