The Safety & Efficacy of Etanercept in Psoriasis Patients Who Have Not Responded to Adalimumab

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
Dermatrials Research
ClinicalTrials.gov Identifier:
NCT00833729
First received: January 30, 2009
Last updated: June 25, 2010
Last verified: June 2010
  Purpose

To describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis. A total of 10 patients with moderate to severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of mild or worse will be transitioned to etanercept 50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.


Condition Intervention Phase
Plaque Psoriasis
Drug: etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Prospective Cohort Pilot Study to Evaluate the Efficacy and Safety of Etanercept in the Treatment of Moderate to Severe Plaque Psoriasis in Patients Who Have Not Had an Adequate Response to Adalimumab

Resource links provided by NLM:


Further study details as provided by Dermatrials Research:

Primary Outcome Measures:
  • Mean change in PGA score [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in body surface area covered in psoriasis [ Time Frame: Baseline to 12 weeks and again at 24 weeks ] [ Designated as safety issue: No ]
  • Mean change in DLQI [ Time Frame: Baseline to 12 weeks and again at 24 weeks ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: Baseline to 12 weeks and again at 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving an improvement in PGA score [ Time Frame: Baseline to 12 weeks and again at 24 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Baseline to 12 weeks and again at 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: etanercept
Single armed study
Drug: etanercept
50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.

Detailed Description:

A total of 10 patients with moderate to severe psoriasis who are currently using adalimumab for at least 12 weeks but have a PGA of mild or worse will be transitioned to etanercept 50 mg twice weekly (BIW) for 12 wks followed by a dose reduction to 50mg once weekly (OW) for an additional 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is ≥ 18 years of age.
  • Subject has had a diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months
  • Subject has had a sub-optimal response to continuous treatment with adalimumab administered for at least 3 consecutive months prior to screening, with no treatment interruptions exceeding 14 days, at doses of 40 mg every other week (eow) after a loading of 80mg sc. The last dose of adalimumab must be greater than 11 days and less than 17 days before the first dose of etanercept.
  • PGA of mild or worse
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile or is of childbearing potential and is practicing an approved method of birth control throughout the study. The results of a urine pregnancy test performed at the screening visit must be negative.
  • Subject is judged to be in generally good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination performed at screening.
  • Subject must be able to self-administer or has a qualified designee who can reliably administer SC injections.
  • Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
  • Subject has a negative PPD test at within 6 months of screening.
  • Able to start etanercept per the approved Enbrel® product monograph

Exclusion Criteria:

  • Previous treatment with etanercept
  • Subject receives or requires:
  • UVB phototherapy, (other than narrow-band UVB), excessive sun exposure or the use of tanning booths within 14 days prior to Baseline visit.
  • PUVA phototherapy within 14 days prior to Baseline visit.
  • Systemic non-biologic therapies for psoriasis within 30 days prior to Baseline visit.
  • Biologic therapies (excluding adalimumab) for psoriasis within 30 days prior to Baseline visit.
  • High potentcy topical steroids during the study period
  • Received any investigational agent within 30 days or 5 half lives prior to Baseline (whichever is longer), or within a duration of its known pharmacological activity.
  • Subject has other active skin diseases or skin infections (bacterial, fungal, viral or parasitic) that may interfere with evaluation of psoriasis.
  • Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline.
  • History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
  • History of CNS demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease.
  • History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB.
  • Known hypersensitivity to the excipients of etanercept as stated in the label.
  • Erythrodermic psoriasis generalized or localized pustular psoriasis, medication−induced or medication-exacerbated psoriasis or new onset guttate psoriasis.
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
  • Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
  • History of clinically significant drug or alcohol abuse in the last 12 months.
  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.
  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: NCT00833729

Locations
Canada, Ontario
Dermatrials Research
Hamilton, Ontario, Canada, L8N 1V6
Sponsors and Collaborators
Dermatrials Research
Amgen
Investigators
Principal Investigator: Ronald Vender, MD FRCPC Dermatrials Research
  More Information

No publications provided by Dermatrials Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronald Vender, MD, Dermatrials Research
ClinicalTrials.gov Identifier: NCT00833729     History of Changes
Other Study ID Numbers: CA-2008-0008
Study First Received: January 30, 2009
Last Updated: June 25, 2010
Health Authority: Canada:Institutional Review Board Services

Keywords provided by Dermatrials Research:
psoriasis
etanercept
adalimumab
moderate to severe plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Adalimumab
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 August 20, 2014