An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use (ENBRECAP2009)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Florida Academic Dermatology Centers.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Amgen
Information provided by:
Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier:
NCT01132235
First received: May 25, 2010
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.


Condition Intervention Phase
Psoriasis
Biological: etanercept
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: An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use

Resource links provided by NLM:


Further study details as provided by Florida Academic Dermatology Centers:

Primary Outcome Measures:
  • The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12 will measure efficacy of retreatment with etanercept


Estimated Enrollment: 20
Study Start Date: April 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: etanercept
    50mgs subcutaneous injections twice a week for 12 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with psoriasis who have previously been treated with etanercept for a minimum of 6 months and discontinued treatment due to loss of efficacy. Every attempt will be made to obtain loss of efficacy history from the subject's medical chart;when etanercept was commenced and terminated and description of patient's psoriasis on termination and details of new treatment commenced. Subjects must have failed their latest psoriasis treatment after a period of three months. This will be measured as a PGA of ≥ 3.
  • There is no specific requirement as to when prior treatment with etanercept occurred and no requirement as to what type of treatment(s) used between initial and subsequent treatments.
  • Are ≥ 18 years of age
  • PGA ≥ 3
  • BSA minimum of 5%

Tuberculosis inclusion criteria

  • Have no history of latent or active TB prior to screening.
  • Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
  • Have had no recent close contact with a person with active TB.
  • Within 1 month prior to the first administration of study have a negative tuberculin skin test.

    • The ability to give written informed consent and comply with study procedures.

Exclusion Criteria:

  • Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit.
  • Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
  • Latex sensitivity [NB: only applicable if they are using prefilled syringe or prefilled SureClick™ autoinjector presentations]
  • Prior or concurrent use of cyclophosphamide therapy
  • Concurrent sulfasalazine therapy.
  • A positive HBV test or known history of any other immuno-suppressing disease.
  • Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication.
  • Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.
  • History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection and Hepatitis C, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB, or other opportunistic infections
  • If etanercept was previously discontinued due to a serious adverse event
  • Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer])
  • Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.
  • Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live vaccine.
  • Any condition or circumstances judged by the patient's physician [or the investigator or medically qualified study staff] to render this clinical trial detrimental or otherwise unsuitable for the patient's participation.
  • Female subjects who are pregnant, nursing or planning pregnancy (both men and women) and not using acceptable methods of birth control during the trial (hormonal, barriers, abstinence).
  • Women who are breast feeding

History of non-compliance with other therapies.

  • History of alcohol abuse within the last 12 months
  • Concurrent use of anakinra
  • Subjects who cannot discontinue any of the drugs below for 2 weeks prior to the baseline visit or during the study;

A two week wash out period is appropriate as it would be unethical to expect subjects whose disease if flaring to remain untreated for a longer period of time. The first dose of etanercept will be administered two weeks after the last biologic dose.

  • Immunosuppressants, antimalarials, or sulfasalazine.
  • Other Ani-TNFs
  • Cyclosporine
  • Efalizumab
  • Azathioprine
  • Hydroxyurea
  • Live vaccines
  • Tacrolimus
  • Oral retinoids (isotretinoin,acitretin,bexarotene)
  • Ultra violet light therapies
  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: NCT01132235

Locations
United States, Florida
Florida Academic Dermatology Center Recruiting
Miami, Florida, United States, 33136
Contact: Annika M Grant, RN.MBA    305-324-2110 ext 210    annikagrant@bellsouth.net   
Sponsors and Collaborators
Florida Academic Dermatology Centers
Amgen
  More Information

No publications provided

Responsible Party: Francisco A Kerdel, M.D., Florida Academic Dermatology Centers
ClinicalTrials.gov Identifier: NCT01132235     History of Changes
Other Study ID Numbers: ENBRECAP2009
Study First Received: May 25, 2010
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 October 19, 2014