Safety and Efficacy of Combining nbUVB to Etanercept in Patients
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Etanercept; nbUVB
Intervention description: Etanercept 50 mg, subcutaneous (SC) injection.
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Etanercept, UVB, Enbrel, Psoriasis.

Summary:

      This study will provide data on the addition of narrow band ultra violet B (nbUVB)
      phototherapy to participants who have not shown an excellent response to three months of
      etanercept.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older;

          -  Patient with moderate to severe plaque psoriasis for whom a decision to use etanercept
             has been made;

          -  At the investigator discretion, patient who would benefit from systemic therapy;

          -  PASI (psoriasis area and severity index) ≥ 10 and BSA (body surface area affected by
             psoriasis) ≥ 10 at day 0;

          -  Unless surgically sterile (or at least 1 year post-menopausal for women), abstinent or
             homosexual, patient (men and women) willing to use adequate contraceptive method for
             at least 30 days before Day 0 and until one month after the last drug administration;

          -  Patient capable of giving informed consent;

          -  Patient with normal or non clinically significant chest X ray within six months of
             screening;

          -  Patient with negative purified protein derivative (PPD) within 3 months of Day 0;

          -  Negative urine pregnancy test for women of childbearing potential

        Exclusion Criteria:

          -  Patient used topical steroid, topical tar preparations, or other anti-psoriatic
             preparations except tar or salicylic acid shampoo or hydrocortisone for the face,
             scalp, genital and inframammary areas within two weeks of Day 0;

          -  Patient with presence of erythrodermic, pustular or a predominantly guttate psoriasis;

          -  At the investigator's discretion, patient with any significant infection within 30
             days of screening or a patient at risk of septicemia;

          -  Patient with evidence of any skin condition that would interfere with the evaluation
             of psoriasis;

          -  Patient used investigational drugs within 12 weeks or three half-life of Day 0
             whichever is longer;

          -  Patient used systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate,
             cyclosporine within four weeks of Day 0;

          -  Patient used any biologic such as alefacept, etanercept, efalizumab, infliximab and
             adalimumab within 12 weeks of Day 0;

          -  Patient used ultraviolet light therapy (UVB or nbUVB) within four weeks of Day 0 or
             PUVA (psoralen ultra violet A) within eight weeks of Day 0;

          -  Patient with prior or concurrent use of cyclophosphamide;

          -  Patient with concurrent sulfasalazine therapy or concurrent use of anakinra;

          -  Patient with 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 diabetes mellitus requiring insulin;
             congestive heart failure (NYHA (New York Heart Association) class III or IV) or
             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 with a known sero-positivity for HIV (human immunodeficiency virus) or history
             of any other immunosuppressing disease;

          -  Patient with active or chronic hepatitis B or C;

          -  Patient with any active or chronic infection within four weeks before screening or
             between the screening and baseline visits;

          -  Patient with any mycobacterial disease, patient with a positive PPD, a chest X-Ray
             suggestive of tuberculosis or patient taking anti-tuberculosis medication;

          -  Patient with a known hypersensitivity to etanercept or one of its components or known
             to have antibodies to etanercept;

          -  Patient who received a live attenuated vaccines within 12 weeks of Day 0 or plan to
             receive one during the study;

          -  Current pregnancy or lactation;

          -  At the investigator's discretion, patient with current or history of alcohol or drug
             abuse that would interfere with the ability of the patient to comply with the study
             protocol;

          -  Patient with systemic lupus erythematosus or demyelinating disorder (optic neuritis,
             multiple sclerosis or other);

          -  Patient with a history of cancer within five years of Day 0 or presence of cancer
             except for treated basal or squamous cell carcinoma and in situ cervix carcinoma;

          -  Patient who failed to respond to nbUVB in the past;

          -  Patient who have a contra-indication to nbUVB;

          -  Patient with latex sensitivity (applicable only if they are using prefilled syringe or
             prefilled SureClickTM autoinjector presentations);

          -  Patient with a history of non-compliance with other therapies.