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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

May 25, 2010
May 27, 2010
April 2010
December 2010   (final data collection date for primary outcome measure)
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
Primary Outcome Measurement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The primary endpoint to be measured is the number of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12.
Complete list of historical versions of study NCT01132235 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use
An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
Biological: etanercept
50mgs subcutaneous injections twice a week for 12 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01132235
ENBRECAP2009
No
Francisco A Kerdel, M.D., Florida Academic Dermatology Centers
Florida Academic Dermatology Centers
Amgen
Not Provided
Florida Academic Dermatology Centers
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP