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

NCT ID: NCT00967538

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-07-31

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Etanercept

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.

Group Type: EXPERIMENTAL

etanercept 50 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Enbrel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Innovaderm Research Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald B Vender, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatrials Research

Robert Bissonnette, MD

Role: PRINCIPAL_INVESTIGATOR

Innovaderm Research Inc.

Locations

Kirk Barber Research

Calgary, Alberta, Canada

PerCuro Clinical Research Ltd

Victoria, British Columbia, Canada

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, Canada

Nexus Clinical Research

St. John's, Newfoundland and Labrador, Canada

New Lab Clinical Research

St. John's, Newfoundland and Labrador, Canada

Eastern Canada Cutaneous Research Associates Ltd

Halifax, Nova Scotia, Canada

Sudbury Skin Clinic

Greater Sudbury, Ontario, Canada

Dermatrials Research

Hamilton, Ontario, Canada

Mediprobe Research Inc.

London, Ontario, Canada

Lynderm research Inc.

Markham, Ontario, Canada

Dermatology Associates

North York, Ontario, Canada

Dr. Jay Brian Taradash

Toronto, Ontario, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

Siena Medical Research

Montreal, Quebec, Canada

Centre de Recherches Dermatologiques du Quebec Metropolitain

Québec, Quebec, Canada

Clinique Esthetique Dr Isabelle Delorme

Saint-Hyacinthe, Quebec, Canada

Countries

Canada

Other Identifiers

CA-2009-0004

Identifier Type: -

Identifier Source: secondary_id

Inno-6011

Identifier Type: -

Identifier Source: org_study_id