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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967538
• Other study ID #: Inno-6011
• Secondary ID: CA-2009-0004
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2009
• Last updated: July 23, 2014
• Start date: September 2009
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Innovaderm Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• etanercept 50 mg
All patients will receive etanercept 50 mg twice a week for 12 weeks followed by 50 mg once a week for an additional 12 weeks.

Locations

Country	Name	City	State
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Eastern Canada Cutaneous Research Associates Ltd	Halifax	Nova Scotia
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Mediprobe Research Inc.	London	Ontario
Canada	Lynderm research Inc.	Markham	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	Siena Medical Research	Montreal	Quebec
Canada	Dermatology Associates	North York	Ontario
Canada	Centre de Recherches Dermatologiques du Quebec Metropolitain	Quebec
Canada	New Lab Clinical Research	St John's	Newfoundland and Labrador
Canada	Nexus Clinical Research	St John's	Newfoundland and Labrador
Canada	Clinique Esthetique Dr Isabelle Delorme	St-Hyacinthe	Quebec
Canada	Sudbury Skin Clinic	Sudbury	Ontario
Canada	Dr. Jay Brian Taradash	Toronto	Ontario
Canada	PerCuro Clinical Research Ltd	Victoria	British Columbia
Canada	Winnipeg Clinic Dermatology Research	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Innovaderm Research Inc.	Amgen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		24 weeks	No
Secondary	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.		24 weeks	No
Secondary	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.		24 weeks	No
Secondary	Mean Body Surface Area (BSA) after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab.		24 weeks	No
Secondary	Mean BSA after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW.		24 weeks	No
Secondary	Mean BSA after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW.		24 weeks	No
Secondary	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.		24 weeks	No
Secondary	Mean PASI score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW.		24 weeks	No
Secondary	Mean PASI score after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW.		24 weeks	No
Secondary	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.		24 weeks	Yes