Safety and Efficacy of Etanercept in Patients With Psoriasis Who Failed to Respond to Other Biologic Treatments
Information source: Innovaderm Research Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: etanercept 50 mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Innovaderm Research Inc. Official(s) and/or principal investigator(s): Ronald B Vender, MD, Principal Investigator, Affiliation: Dermatrials Research Robert Bissonnette, MD, Principal Investigator, Affiliation: Innovaderm Research Inc.
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.
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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).
Secondary outcome: 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.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. Mean Body Surface Area (BSA) after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab. Mean BSA after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW. Mean BSA after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW. 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. Mean PASI score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW. Mean PASI score after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Centre de Recherches Dermatologiques du Quebec Metropolitain, Quebec G1V 4X7, Canada
Kirk Barber Research, Calgary, Alberta T2S3B3, Canada
PerCuro Clinical Research Ltd, Victoria, British Columbia V8V 3P9, Canada
Winnipeg Clinic Dermatology Research, Winnipeg, Manitoba R3C 0N2, Canada
New Lab Clinical Research, St John's, Newfoundland and Labrador A1C 2H5, Canada
Nexus Clinical Research, St John's, Newfoundland and Labrador A1A 5E8, Canada
Eastern Canada Cutaneous Research Associates Ltd, Halifax, Nova Scotia B3H 1Z4, Canada
Dermatrials Research, Hamilton, Ontario L8N 1V6, Canada
Mediprobe Research Inc., London, Ontario N5X 2P1, Canada
Lynderm research Inc., Markham, Ontario L3P 1A8, Canada
Dermatology Associates, North York, Ontario M4A 2V6, Canada
Sudbury Skin Clinic, Sudbury, Ontario P3E 5M4, Canada
Dr. Jay Brian Taradash, Toronto, Ontario M4V 1R1, Canada
Innovaderm Research Inc., Montreal, Quebec H2K 4L5, Canada
Siena Medical Research, Montreal, Quebec H3A 1A1, Canada
Clinique Esthetique Dr Isabelle Delorme, St-Hyacinthe, Quebec J2S 6L6, Canada
Additional Information
Starting date: September 2009
Last updated: July 23, 2014
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