Safety and Efficacy of Etanercept in Patients With Psoriasis Who Failed to Respond to Other Biologic Treatments

Condition(s) targeted: Psoriasis

Intervention: etanercept 50 mg (Drug)

Phase: Phase 4

Status: Recruiting

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.

Overall contact:
Caroline Robillard, Phone: 514.521.4285, Ext: 262, Email: crobillard@innovaderm.ca

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.

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: Allocation: Non-Randomized, 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.

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

Caroline Robillard, Phone: 514.521.4285, Ext: 262, Email: crobillard@innovaderm.ca

Centre de Recherches Dermatologiques du Quebec Metropolitain, Quebec G1V 4X7, Canada; Recruiting
Josee Dumas, Phone: 418-650-0777, Email: crdq@bellnet.ca
Yves Poulin, MD, Principal Investigator

Kirk Barber Research, Calgary, Alberta T2S3B3, Canada; Recruiting
Kirk Barber, MD, Phone: 403-299-5821, Email: kirk@kirkbarber.ca
Arjuni Seevaratnam, Phone: 403-299-5821, Email: arjuni@kirkbarber.ca
Kirk Barber, MD, Principal Investigator

PerCuro Clinical Research Ltd, Victoria, British Columbia V8V 3P9, Canada; Recruiting
John D Amiss, MD, Principal Investigator

Winnipeg Clinic Dermatology Research, Winnipeg, Manitoba R3C 0N2, Canada; Recruiting
Richard P Haydey, MD, Principal Investigator
Jill Alison Keddy-Grant, MD, Sub-Investigator
Robert W Mouton, MD, Sub-Investigator
Victoria K Taraska, MD, Sub-Investigator
Marcie J Ulmer, MD, Sub-Investigator
Rachelle S Van De Velde, MD, Sub-Investigator

New Lab Clinical Research, St John's, Newfoundland and Labrador A1C 2H5, Canada; Recruiting
Wayne P Gulliver, MD, Principal Investigator
Kamal Ohson, MD, Sub-Investigator
Andrew Hutton, MD, Sub-Investigator

Nexus Clinical Research, St John's, Newfoundland and Labrador A1A 5E8, Canada; Recruiting
Ian DR Landells, MD, Principal Investigator
Carla Saldanha, MD, Sub-Investigator

Eastern Canada Cutaneous Research Associates Ltd, Halifax, Nova Scotia B3H 1Z4, Canada; Recruiting
Richard GB Langley, MD, Principal Investigator
Alexander H Murray, MD, Sub-Investigator
Robert AW Miller, MD, Sub-Investigator
Scott J Murray, MD, Sub-Investigator

Dermatrials Research, Hamilton, Ontario L8N 1V6, Canada; Recruiting
Ronald B Vender, MD, Principal Investigator
Francis R Murphy, MD, Sub-Investigator

Mediprobe Research Inc., London, Ontario N5X 2P1, Canada; Recruiting
Aditya K Gupta, MD, Principal Investigator

Lynderm research Inc., Markham, Ontario L3P 1A8, Canada; Recruiting
Charles W Lynde, MD, Principal Investigator
Francesca Cheung, MD, Sub-Investigator

Dermatology Associates, North York, Ontario M4A 2V6, Canada; Recruiting
Grace Ma, Email: graci@hotmail.com
Jensen Yeung, MD, Principal Investigator

Sudbury Skin Clinic, Sudbury, Ontario P3E 5M4, Canada; Recruiting
Lyne L Giroux, MD, Principal Investigator

Dr. Jay Brian Taradash, Toronto, Ontario M4V 1R1, Canada; Recruiting
Beverly Linden, Phone: 416-961-3643, Email: bjlinden@rogers.com
Jay Taradash, MD, Principal Investigator

Innovaderm Research Inc., Montreal, Quebec H2K 4L5, Canada; Recruiting
Catherine Maari, MD, Principal Investigator
Robert Bissonnette, MD, Sub-Investigator
Chantal Bolduc, MD, Sub-Investigator
Simon Nigen, MD, Sub-Investigator
Pierre Lanouette, MD, Sub-Investigator

Siena Medical Research, Montreal, Quebec H3A 1A1, Canada; Recruiting
Wayne Carey, MD, Principal Investigator
Beatrice Wang, MD, Sub-Investigator

Clinique Esthetique Dr Isabelle Delorme, St-Hyacinthe, Quebec J2S 6L6, Canada; Recruiting
Isabelle Delorme, MD, Principal Investigator

Starting date: September 2009
Last updated: January 15, 2013