- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00833729
The Safety & Efficacy of Etanercept in Psoriasis Patients Who Have Not Responded to Adalimumab
October 7, 2020 updated by: Ronald Vender MD FRCPC, Dermatrials Research
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 1V6
- Dermatrials Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: etanercept
Single armed study
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50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in PGA score
Time Frame: Baseline to 12 weeks
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Baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean change in body surface area covered in psoriasis
Time Frame: Baseline to 12 weeks and again at 24 weeks
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Baseline to 12 weeks and again at 24 weeks
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Mean change in DLQI
Time Frame: Baseline to 12 weeks and again at 24 weeks
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Baseline to 12 weeks and again at 24 weeks
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Treatment satisfaction
Time Frame: Baseline to 12 weeks and again at 24 weeks
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Baseline to 12 weeks and again at 24 weeks
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Proportion of patients achieving an improvement in PGA score
Time Frame: Baseline to 12 weeks and again at 24 weeks
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Baseline to 12 weeks and again at 24 weeks
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Mean change in adverse events
Time Frame: Baseline to 12 weeks and again at 24 weeks
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Baseline to 12 weeks and again at 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ronald Vender, MD FRCPC, Dermatrials Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 30, 2009
First Submitted That Met QC Criteria
January 30, 2009
First Posted (Estimate)
February 2, 2009
Study Record Updates
Last Update Posted (Actual)
October 9, 2020
Last Update Submitted That Met QC Criteria
October 7, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- CA-2008-0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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