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

NCT00967538 | Completed Phase 4

• 2 other identifiers: Inno-6011CA-2009-0004
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 16

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

Keywords

psoriasis; etanercept; efficacy; response; anti-TNF alpha; treatment efficacy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

• 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

• 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

• 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

• Mean BSA after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW.

  24 weeks

Study Arms (1)

Etanercept

EXPERIMENTAL

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.

Drug: etanercept 50 mg

Interventions

etanercept 50 mg 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.

Also known as: Enbrel

Etanercept

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Amgen: collaborator

Study Sites (16)

Kirk Barber Research

Calgary, Alberta, T2S3B3, Canada

Location

PerCuro Clinical Research Ltd

Victoria, British Columbia, V8V 3P9, Canada

Location

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

New Lab Clinical Research

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Eastern Canada Cutaneous Research Associates Ltd

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Sudbury Skin Clinic

Greater Sudbury, Ontario, P3E 5M4, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1V6, Canada

Location

Mediprobe Research Inc.

London, Ontario, N5X 2P1, Canada

Location

Lynderm research Inc.

Markham, Ontario, L3P 1A8, Canada

Location

Dermatology Associates

North York, Ontario, M4A 2V6, Canada

Location

Dr. Jay Brian Taradash

Toronto, Ontario, M4V 1R1, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Siena Medical Research

Montreal, Quebec, H3A 1A1, Canada

Location

Centre de Recherches Dermatologiques du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Clinique Esthetique Dr Isabelle Delorme

Saint-Hyacinthe, Quebec, J2S 6L6, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Ronald B Vender, MD

  Dermatrials Research

  PRINCIPAL INVESTIGATOR

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 28, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

CA (16)