PsoriasisNCT02258282
Safety and Efficacy of Etanercept in Patients With Psoriasis
A study testing Etanercept in people with Psoriasis, run by Chengdu PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Etanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2022
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs
- 18 to 75 years old
- has PGA of 3 or more at Day 0
- has BSA of 3% or more at Day 0
- has psoriasis severe enough to be eligible to systemic therapy
- willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 1 month after the last drug administration;
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- capable of giving informed consent
- with normal or non clinically significant chest X-ray within 6 months prior to Day 0
- with negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90 days prior to Day 0
- female patients of childbearing potential have a negative serum pregnancy test
- patient is able to start etanercept per the approved product monograph
Who cannot join
- has used topical steroids, topical tar preparations, or other anti-psoriatic preparations within the two weeks prior to Day 0 or during the study period
- has presence of erythrodermic, pustular or guttate psoriasis
- has had significant infections within the 30 days prior to Day 0
- has received investigational drugs within the four weeks prior to screening or during the study period
- has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or during the study period
- received systemic antibiotics within the four weeks prior to Day 0
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- has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0 or during the study period
- has used infliximab within 14 days of Day 0 or during the study period
- has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to Day 0 or during the study period
- has had an allergic reaction to infliximab
- has an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient
- uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, NYHA class III or IV heart failure, history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris
- uncontrolled hypertension, oxygen-dependent severe pulmonary disease
- has a known sero-positivity for HIV virus or history of any other immunosuppressive disease
- has active or chronic Hepatitis B or C
- has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication
- has a known hypersensitivity to etanercept or one of its components
- has received a live attenuated vaccine within the 12 weeks prior to Day 0 or plans to receive one during the study
- current pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Chengdu Military Area Command PLA
Chengdu, Sichuan, 610083
About this study
The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs.
- Conditions
- Psoriasis
- Being tested
- Etanercept, Control
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
ControlDrug
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Patients under the treatment of 50 mg Etanercept Receives: Drug: Etanercept |
| Control | Sham comparator | Patients under the treatment of traditional DMARDs Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks
Measured: At 0 week, 12 weeks, 24 weeks
Secondary outcomes (2)
Mean Body Surface Area (BSA)
Measured: At 0 week, 12 weeks, 24 weeks
Mean Psoriasis Area and Severity Index (PASI)
Measured: At 0 week, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Min, Chengdu PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258282
- Sponsor's protocol ID
- YSP20140688
- Status last verified
- Mar 2017
- First submitted
- 3 Oct 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Etanercept in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT02258282
- Acronym / sponsor ID
- YSP20140688
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chengdu PLA General HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Oct 2014 (estimated)
- 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 purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: EtanerceptPatients under the treatment of 50 mg Etanercept |
| Control | Sham comparator | Drug: ControlPatients under the treatment of traditional DMARDs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs
- 18 to 75 years old
- has PGA of 3 or more at Day 0
- has BSA of 3% or more at Day 0
- has psoriasis severe enough to be eligible to systemic therapy
Key exclusion criteria (19 listed)
- has used topical steroids, topical tar preparations, or other anti-psoriatic preparations within the two weeks prior to Day 0 or during the study period
- has presence of erythrodermic, pustular or guttate psoriasis
- has had significant infections within the 30 days prior to Day 0
- has received investigational drugs within the four weeks prior to screening or during the study period
- has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etanercept | Drug | Etanercept |
| Control | Drug | Control |
Primary outcome
Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks
Time frame: At 0 week, 12 weeks, 24 weeks
2 secondary outcomes
Mean Body Surface Area (BSA)
Time frame: At 0 week, 12 weeks, 24 weeks
Mean Psoriasis Area and Severity Index (PASI)
Time frame: At 0 week, 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etanercept in people with Psoriasis, run by Chengdu PLA General Hospital at 1 site 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 11 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks (time frame: At 0 week, 12 weeks, 24 weeks). 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 4 Apr 2017.