The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis

Inclusion Criteria

• Is capable of understanding and giving written, voluntary informed consent before study screening
• Male or female ≥18 years of age at time of screening
• Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity)
• Has involved body surface area (BSA) ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline
• Is a candidate for systemic therapy or phototherapy in the opinion of the investigator
• Has a negative test for hepatitis B surface antigen and hepatitis C antibody
• Has a negative purified protein derivative test within 30 days prior to the first IP dose. Tuberculin skin tests should be considered positive when they have greater than or equal to 5 mm of induration at 48-72 hours after test is placed. Patients with a positive tuberculin skin test (if less than or equal to 14 mm of induration) are allowed if they have a history of Bacillus Calmette-Guerin vaccination with a negative Quantiferon test in the past year, no symptoms per tuberculosis worksheet, and a negative chest X ray.
• Has a negative serum pregnancy test within 28 days before initiating Investigational Product (IP) and negative urine pregnancy test at baseline for females (except those at least 3 years post menopausal or surgically sterile)
• Females are willing to use highly effective form of birth control (decided upon with the investigator) during the study and for 3 months after the end of treatment (except women at least 3 years post menopausal or surgically sterile)
• Males are willing to use highly effective form of birth control (decided upon with the investigator) during the study and for 5 months after the end of treatment (except for men who are surgically sterile or whose female partners are at least 3 years post menopausal, surgically sterile, or are using a highly effective form of birth control)
• Men with a pregnant female partner are willing to use effective methods (decided upon with the investigator) to ensure that an unborn child is not exposed to IP via semen
• Patient or designee must have the ability to inject etanercept subcutaneously

Exclusion Criteria

Skin-disease related

• Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
• Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on psoriasis.

Medical conditions

• Has significant concurrent medical conditions, including:
• Type 1 diabetes
• Poorly controlled type 2 diabetes (hemoglobin A1c > 8.5)
• Symptomatic heart failure (New York Heart Association [NYHA] class II, III, or IV)
• Myocardial infarction within the last year
• Current or history of unstable angina pectoris within the last year
• Uncontrolled hypertension as defined by a resting blood pressure ≥ 160/95 mmHg prior to randomization (confirmed by a repeat assessment)
• Severe chronic pulmonary disease (eg, requiring oxygen therapy)
• No major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis
• Multiple sclerosis or any other demyelinating disease
• Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first IP dose. If malignancy occurred more than 5 years ago, documentation of disease-free state since treatment is required.
• Known immunodeficiency syndromes including human immunodeficiency virus (HIV)
• Uncontrolled, clinically significant history of renal disease
• Alcoholic hepatitis
• Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the patient
• Has any active CTC grade 2 or higher infection (including chronic or localized infections) within 30 days prior to s