Plaque PsoriasisPhase 4NCT00833729
The Safety & Efficacy of Etanercept in Psoriasis Patients Who Have Not Responded to Adalimumab
A Phase 4 study testing etanercept in people with Plaque Psoriasis, run by Dermatrials Research at 1 site in Canada.
Trial summary
To describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis. A total of 10 patients with moderate to severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of mild or worse will be transitioned to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Feb 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age.
- Subject has had a diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months
- Subject has had a sub-optimal response to continuous treatment with adalimumab administered for at least 3 consecutive months prior to screening, with no treatment interruptions exceeding 14 days, at doses of 40 mg every other week (eow) after a loading of 80mg sc. The last dose of adalimumab must be greater than 11 days and less than 17 days before the first dose of etanercept.
- PGA of mild or worse
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile or is of childbearing potential and is practicing an approved method of birth control throughout the study. The results of a urine pregnancy test performed at the screening visit must be negative.
- Subject is judged to be in generally good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination performed at screening.
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- Subject must be able to self-administer or has a qualified designee who can reliably administer SC injections.
- Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
- Subject has a negative PPD test at within 6 months of screening.
- Able to start etanercept per the approved Enbrel® product monograph
Who cannot join
- Previous treatment with etanercept
- Subject receives or requires:
- UVB phototherapy, (other than narrow-band UVB), excessive sun exposure or the use of tanning booths within 14 days prior to Baseline visit.
- PUVA phototherapy within 14 days prior to Baseline visit.
- Systemic non-biologic therapies for psoriasis within 30 days prior to Baseline visit.
- Biologic therapies (excluding adalimumab) for psoriasis within 30 days prior to Baseline visit.
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- High potentcy topical steroids during the study period
- Received any investigational agent within 30 days or 5 half lives prior to Baseline (whichever is longer), or within a duration of its known pharmacological activity.
- Subject has other active skin diseases or skin infections (bacterial, fungal, viral or parasitic) that may interfere with evaluation of psoriasis.
- Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline.
- History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
- History of CNS demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease.
- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB.
- Known hypersensitivity to the excipients of etanercept as stated in the label.
- Erythrodermic psoriasis generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis.
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
- History of clinically significant drug or alcohol abuse in the last 12 months.
- Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Prospective Cohort Pilot Study to Evaluate the Efficacy and Safety of Etanercept in the Treatment of Moderate to Severe Plaque Psoriasis in Patients Who Have Not Had an Adequate Response to Adalimumab
To describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis. A total of 10 patients with moderate to severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of mild or worse will be transitioned to etanercept 50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.
Read the detailed description
A total of 10 patients with moderate to severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of mild or worse will be transitioned to etanercept 50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.
- Conditions
- Plaque Psoriasis
- Being tested
- etanercept
- Keywords
- psoriasis, etanercept, adalimumab, moderate to severe plaque psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| etanercept | Experimental | Single armed study Receives: Drug: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in PGA score
Measured: Baseline to 12 weeks
Secondary outcomes (5)
Mean change in body surface area covered in psoriasis
Measured: Baseline to 12 weeks and again at 24 weeks
Mean change in DLQI
Measured: Baseline to 12 weeks and again at 24 weeks
Treatment satisfaction
Measured: Baseline to 12 weeks and again at 24 weeks
Proportion of patients achieving an improvement in PGA score
Measured: Baseline to 12 weeks and again at 24 weeks
Mean change in adverse events
Measured: Baseline to 12 weeks and again at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatrials Research
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Ronald Vender MD FRCPC, Dermatrials Research
- Investigators
- Ronald Vender, MD FRCPC, Principal investigator, Dermatrials Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833729
- Sponsor's protocol ID
- CA-2008-0008
- Status last verified
- Oct 2020
- First submitted
- 30 Jan 2009
- Last updated
- 9 Oct 2020
- Results posted
- No
Publications
Vender R. An open-label, prospective cohort pilot study to evaluate the efficacy and safety of etanercept in the treatment of moderate to severe plaque psoriasis in patients who have not had an adequate response to adalimumab. J Drugs Dermatol. 2011 Apr;10(4):396-402.
PubMed 21455550
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Prospective Cohort Pilot Study to Evaluate the Efficacy and Safety of Etanercept in the Treatment of Moderate to Severe Plaque Psoriasis in Patients Who Have Not Had an Adequate Response to Adalimumab
- ClinicalTrials.gov ID
- NCT00833729
- Acronym / sponsor ID
- CA-2008-0008
- Conditions
- Plaque Psoriasis
- Keywords
- psoriasis, etanercept, adalimumab, moderate to severe plaque psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dermatrials ResearchUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Feb 2009 (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.
To describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis. A total of 10 patients with moderate to severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of mild or worse will be transitioned to etanercept 50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.
Detailed description
A total of 10 patients with moderate to severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of mild or worse will be transitioned to etanercept 50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| etanercept | Experimental | Drug: etanerceptSingle armed study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is ≥ 18 years of age.
- Subject has had a diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months
- Subject has had a sub-optimal response to continuous treatment with adalimumab administered for at least 3 consecutive months prior to screening, with no treatment interruptions exceeding 14 days, at doses of 40 mg every other week (eow) after a loading of 80mg sc. The last dose of adalimumab must be greater than 11 days and less than 17 days before the first dose of etanercept.
- PGA of mild or worse
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile or is of childbearing potential and is practicing an approved method of birth control throughout the study. The results of a urine pregnancy test performed at the screening visit must be negative.
Key exclusion criteria (19 listed)
- Previous treatment with etanercept
- Subject receives or requires:
- UVB phototherapy, (other than narrow-band UVB), excessive sun exposure or the use of tanning booths within 14 days prior to Baseline visit.
- PUVA phototherapy within 14 days prior to Baseline visit.
- Systemic non-biologic therapies for psoriasis within 30 days prior to Baseline visit.
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 |
|---|---|---|
| etanercept50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks. | Drug | etanercept |
Primary outcome
Mean change in PGA score
Time frame: Baseline to 12 weeks
5 secondary outcomes
Mean change in body surface area covered in psoriasis
Time frame: Baseline to 12 weeks and again at 24 weeks
Mean change in DLQI
Time frame: Baseline to 12 weeks and again at 24 weeks
Treatment satisfaction
Time frame: Baseline to 12 weeks and again at 24 weeks
Proportion of patients achieving an improvement in PGA score
Time frame: Baseline to 12 weeks and again at 24 weeks
Mean change in adverse events
Time frame: Baseline to 12 weeks and again at 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 9 Oct 2020.
- Derived from this study: PubMed 21455550Vender R. An open-label, prospective cohort pilot study to evaluate the efficacy and safety of etanercept in the treatment of moderate to severe plaque psoriasis in patients who have not had an adequate response to adalimumab. J Drugs Dermatol. 2011 Apr;10(4):396-402.
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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.
Ronald Vender, MD FRCPC principal investigator
Dermatrials Research
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 testing etanercept in people with Plaque Psoriasis, run by Dermatrials Research at 1 site in Canada.
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 10 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: finished, as of the sponsor's last update on 9 Oct 2020. 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 Canada. 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?
Mean change in PGA score (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833729, which also lists 1 linked publication.
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 9 Oct 2020.