PsoriasisPhase 4NCT02313922
Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate
A Phase 4 study of Psoriasis, run by Zhejiang University at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether etanercept combined with methotrexate are superiority than etanercept as monotherapy in the treatment of chinese severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 466 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Aug 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of both sexes, at least 18 years of age
- have stable plaque psoriasis for at least 6 months, psoriasis involving at least 10 percent of the body surface area, had a minimal PASI of 10 at screening
- had previously received phototherapy or systemic psoriasis therapy at least once or candidates for such therapy in the opinion of the investigator
Who cannot join
- Patients with guttate, erythrodermic, or pustular psoriasis at the time of screening
- recent infection or opportunistic infections, active tuberculosis, hepatitis B and so on
- liver and kidney dysfunction
- those with other serious, progressive, uncontrolled disorders of vital organs and systems (including cardiovascular, liver, lung and kidney), other autoimmune diseases, cancer, HIV infection, which are not suitable for participation in the study of the disease
- history of significant methotrexate toxicity or total cumulative methotrexate exposure > 1000 mg (unless grade ‡ IIIb liver injury has not occurred)
- use of ultraviolet (UV) B therapy, topical ciclosporin or calcineurin inhibitors, class III through VII topical corticosteroids (permitted on the scalp, axillae, and ⁄or groin), or topical vitamin A or D analogues within 14 days of screening
- and psoralen or UVA therapy, systemic psoriasis therapy (including methotrexate), oral retinoids, class I or II topical corticosteroids, dithranol, cyclophosphamide, sulfasalazine, or intravenous or oral calcineurin inhibitors within 28 days of screening
- Patients were excluded if they had received a tumor necrosis factor (TNF) blocking agent or other biologics within 3 months or interleukin (IL)-12 or IL-23 inhibitors within 6 months of study initiation
Trial locations and contacts
1 site in 1 country.
China1 site
the 2Nd Affiliated Hospital,Zhejiang University,
Hangzhou, Zhejiang, 310009
About this study
Official title: Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate: a Phase IV, Multicenter, Randomized, Double-blind, Controlled Trial
The purpose of this study is to evaluate whether etanercept combined with methotrexate are superiority than etanercept as monotherapy in the treatment of chinese severe plaque psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
- Conditions
- Psoriasis
- Being tested
- etanercept combined with methotrexate or etanercept combined with placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanercept combined with methotrexate or etanercept combined with placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| etanercept combined with methotrexate | Experimental | patients treated with etanercept combined with methotrexate Receives: Drug: etanercept combined with methotrexate or etanercept combined with placebo |
| etanercept as monotherapy | Experimental | patients treated with etanercept combined with placebo Receives: Drug: etanercept combined with methotrexate or etanercept combined with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
psoriasis area and severity index 75(PASI75)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
Measured: 24 weeks
Secondary outcomes (4)
psoriasis area and severity index 50(pasi 50)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI50 (a patient that has an improvement from baseline PASI of at least 50%)
Measured: 24 weeks
psoriasis area and severity index 90(pasi 90)
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI90 (a patient that has an improvement from baseline PASI of at least 90%)
Measured: 24 weeks
Dermatology Life Quality Index (DLQI) change
Change from baseline in plaque psoriasis as assessed by DLQI (dermatology life quality index ) response
Measured: 24 weeks
adverse events(AEs)
Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2018
- Study completionAug 2018
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 Zhejiang UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai CP Guojian Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Min Zheng, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313922
- Sponsor's protocol ID
- C301-PS
- Status last verified
- Aug 2018
- First submitted
- 8 Dec 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Psoriasis Treatment of Etanercept Combined Methotrexate: a Phase IV, Multicenter, Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT02313922
- Acronym / sponsor ID
- C301-PS
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shanghai CP Guojian Pharmaceutical Co., Ltd.
- Study start
- Nov 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 10 Dec 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 whether etanercept combined with methotrexate are superiority than etanercept as monotherapy in the treatment of chinese severe plaque psoriasis. A phase IV, multicenter, randomized, double-blind, controlled trial was conducted.The primary outcome was Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etanercept combined with methotrexate | Experimental | Drug: etanercept combined with methotrexate or etanercept combined with placebopatients treated with etanercept combined with methotrexate |
| etanercept as monotherapy | Experimental | Drug: etanercept combined with methotrexate or etanercept combined with placebopatients treated with etanercept combined with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of both sexes, at least 18 years of age
- have stable plaque psoriasis for at least 6 months, psoriasis involving at least 10 percent of the body surface area, had a minimal PASI of 10 at screening
- had previously received phototherapy or systemic psoriasis therapy at least once or candidates for such therapy in the opinion of the investigator
Key exclusion criteria (8 listed)
- Patients with guttate, erythrodermic, or pustular psoriasis at the time of screening
- recent infection or opportunistic infections, active tuberculosis, hepatitis B and so on
- liver and kidney dysfunction
- those with other serious, progressive, uncontrolled disorders of vital organs and systems (including cardiovascular, liver, lung and kidney), other autoimmune diseases, cancer, HIV infection, which are not suitable for participation in the study of the disease
- history of significant methotrexate toxicity or total cumulative methotrexate exposure > 1000 mg (unless grade ‡ IIIb liver injury has not occurred)
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 combined with methotrexate or etanercept combined with placebo | Drug | etanercept as monotherapy, etanercept combined with methotrexate |
Primary outcome
psoriasis area and severity index 75(PASI75)
Time frame: 24 weeks
Change from baseline in plaque psoriasis as assessed by PASI (psoriasis area and severity index) response or PASI75 (a patient that has an improvement from baseline PASI of at least 75%)
4 secondary outcomes
psoriasis area and severity index 50(pasi 50)
Time frame: 24 weeks
psoriasis area and severity index 90(pasi 90)
Time frame: 24 weeks
Dermatology Life Quality Index (DLQI) change
Time frame: 24 weeks
adverse events(AEs)
Time frame: 24 weeks
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 17 Aug 2018.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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 Phase 4 study of Psoriasis, run by Zhejiang University 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 3 inclusion and 8 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 17 Aug 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
psoriasis area and severity index 75(PASI75) (time frame: 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 17 Aug 2018.