Clinical trial NCT00967538: Safety and Efficacy of Etanercept in Patients With Psoriasis Who Failed to Respond to Other Biologic Treatments
Official title: Safety and Efficacy of Etanercept in Patients With Moderate to Severe Plaque Psoriasis Who Have Shown an Unsatisfactory Response to Adalimumab or Infliximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: psoriasis
etanercept
efficacy
response
anti-TNF alpha
treatment efficacy
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2009-08-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to adalimumab and infliximab.


Eligibility criteria: Inclusion Criteria:

* Patient has plaque psoriasis and has shown an unsatisfactory response to adalimumab. Unsatisfactory response is defined as patients who failed to reach a PGA of clear or almost clear (PGA of 0 or 1) following at least 12 weeks with adalimumab at 40 mg EOW; OR
* Patient has plaque psoriasis and has lost his/her satisfactory response to adalimumab. Loss of satisfactory response is defined as patients treated with adalimumab 40 mg EOW for at least 12 weeks, who achieved a PGA of clear or almost clear (PGA of 0 or 1) but lost this PGA response (increase in PGA to 2, 3, 4 or 5) at any time after 12 weeks of adalimumab; OR
* Patient has plaque psoriasis and has lost his/her satisfactory response to infliximab. Loss of satisfactory response is defined as patients treated with at least 3 infliximab infusions at 5 mg/kg, who achieved a PGA of clear or almost clear (PGA of 0 or 1) but lost this PGA response (increase in PGA to 2, 3, 4 or 5) at any time after the 3rd infusion of infliximab;
* Patient's age is 18 to 80 years old;
* Patient has PGA of 3 or more at Day 0;
* Patient has BSA of 3% or more at Day 0;
* Patient has psoriasis severe enough to be eligible to systemic therapy;
* Unless surgically sterile (or at least 1 year post-menopausal for women), or abstinent, patient (male or female) is 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;
* Patient capable of giving informed consent;
* Patient with normal or non clinically significant chest X-ray within 6 months prior to Day 0;
* Patient 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.

Exclusion Criteria:

* Patient 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, unless patient used topical therapy during the last 4 weeks of the period when the patient lost their satisfactory response to adalimumab or infliximab or when the patient failed to achieve a satisfactory response to adalimumab;
* Patient has presence of erythrodermic, pustular or guttate psoriasis;
* Patient has had significant infections within the 30 days prior to Day 0;
* Patient has received investigational drugs within the four weeks prior to screening or during the study period;
* Patient 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;
* Patient received systemic antibiotics within the four weeks prior to Day 0;
* Patient has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0 or during the study period;
* Patient has used adalimumab or infliximab within 14 days of Day 0 or during the study period;
* Patient has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to Day 0 or during the study period;
* Patient has had an allergic reaction to adalimumab, infliximab or etanercept;
* Patient 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;
* Patient has a known sero-positivity for HIV virus or history of any other immunosuppressive disease;
* Patient has active or chronic Hepatitis B or C;
* Patient has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication;
* Patient has a known hypersensitivity to etanercept or one of its components;
* Patient 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;
* At the investigator

Primary outcomes:
measure: Proportion of patients who reach a Physician's Global Assessment (PGA) of clear or almost clear after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg every other week (EOW).
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of patients who reach a PGA of clear or almost clear after 12 and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW.
timeFrame: 24 weeks
measure: Proportion of patients who reach a PGA of clear or almost clear after 12 and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab.
timeFrame: 24 weeks
measure: Mean Body Surface Area (BSA) after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab.
timeFrame: 24 weeks
measure: Mean BSA after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW.
timeFrame: 24 weeks
measure: Mean BSA after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW.
timeFrame: 24 weeks
measure: Mean Psoriasis Area and Severity Index (PASI) score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab.
timeFrame: 24 weeks
measure: Mean PASI score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW.
timeFrame: 24 weeks
measure: Mean PASI score after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW.
timeFrame: 24 weeks
measure: Safety of etanercept in patients who have shown an unsatisfactory response to adalimumab, who have lost their satisfactory response to adalimumab or who have lost their satisfactory response to infliximab.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic Dermatology Research
state: Manitoba
city: St John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: St John's
country: Canada
facility: New Lab Clinical Research
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates Ltd
state: Nova Scotia
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: London
country: Canada
facility: Mediprobe Research Inc.
state: Ontario
city: Markham
country: Canada
facility: Lynderm research Inc.
state: Ontario
city: North York
country: Canada
facility: Dermatology Associates
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Skin Clinic
state: Ontario
city: Toronto
country: Canada
facility: Dr. Jay Brian Taradash
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: St-Hyacinthe
country: Canada
facility: Clinique Esthetique Dr Isabelle Delorme
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherches Dermatologiques du Quebec Metropolitain
Study officials:
affiliation: Dermatrials Research
name: Ronald B Vender, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: