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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Innovaderm Research Inc.
ClinicalTrials.gov Identifier:
NCT00967538
First received: August 26, 2009
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: etanercept 50 mg
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Innovaderm Research Inc.:

Primary Outcome Measures:
  • 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). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean Body Surface Area (BSA) after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean BSA after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean BSA after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean PASI score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean PASI score after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: September 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Enbrel

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967538

Locations
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2S3B3
Canada, British Columbia
PerCuro Clinical Research Ltd
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Newfoundland and Labrador
New Lab Clinical Research
St John's, Newfoundland and Labrador, Canada, A1C 2H5
Nexus Clinical Research
St John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Nova Scotia
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Dermatrials Research
Hamilton, Ontario, Canada, L8N 1V6
Mediprobe Research Inc.
London, Ontario, Canada, N5X 2P1
Lynderm research Inc.
Markham, Ontario, Canada, L3P 1A8
Dermatology Associates
North York, Ontario, Canada, M4A 2V6
Sudbury Skin Clinic
Sudbury, Ontario, Canada, P3E 5M4
Dr. Jay Brian Taradash
Toronto, Ontario, Canada, M4V 1R1
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Siena Medical Research
Montreal, Quebec, Canada, H3A 1A1
Clinique Esthetique Dr Isabelle Delorme
St-Hyacinthe, Quebec, Canada, J2S 6L6
Canada
Centre de Recherches Dermatologiques du Quebec Metropolitain
Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Innovaderm Research Inc.
Amgen
Investigators
Principal Investigator: Ronald B Vender, MD Dermatrials Research
Principal Investigator: Robert Bissonnette, MD Innovaderm Research Inc.
  More Information

No publications provided

Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT00967538     History of Changes
Other Study ID Numbers: Inno-6011, CA-2009-0004
Study First Received: August 26, 2009
Last Updated: July 23, 2014
Health Authority: Canada: Health Canada

Keywords provided by Innovaderm Research Inc.:
psoriasis
etanercept
efficacy
response
anti-TNF alpha
treatment efficacy

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014