Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male or female adult (≥ 18yrs) with a diagnosis of moderate to severe plaque psoriasis
Subject must have ≥ 10% body surface area involvement
Subject must have psoriasis area and severity index (PASI) ≥12
Subject has stable psoriasis of at least six months' duration

Male subjects must agree to use a reliable form of birth control during the study and for 180 days after the last dose of study drug. Male subjects must not donate sperm during the study or for 180 days after the last dose of study drug. If female, subject is either not of childbearing potential (postmenopausal for at least 1 year or surgically sterile) or is of childbearing potential and is using approved method of birth control throughout study and for 180 days after last dose of study drug. Approved methods of birth control include the following:

Condoms, sponge, foams, jellies, diaphragm, or intrauterine device (IUD)
Hormonal contraceptives for 90 days prior to study drug administration
A vasectomized partner
Subject has negative PPD tuberculosis skin test at screening assessment.
Subject must be able and willing to provide written informed consent and comply with requirements of this study protocol.

Exclusion Criteria

Diagnosis or presence of guttate, erythrodermic or pustular psoriasis
Any previous exposure to ADA including biosimilar ADA
Moderate to high strength topical steroids (class 4 or greater) or Vitamin D analogues within one week of study entry
Oral systemic therapy (methotrexate, cyclosporine, apremilast, acitretin) within 8 weeks of study entry
Previous intolerance or adverse reaction to MTX
Phototherapy of any type within 4 weeks of study entry (narrowband UVB, psoralen-UVA, 308 nM LASER, commercial tanning units)
IL-12/23 inhibitors (ustekinumab) and any IL-23 inhibitor (guselkumab, tildrakizumab, risankizumab) within 12 weeks of baseline
Other biologic agents within 8 weeks of study entry
History of chronic liver disease, hepatitis, or alcohol abuse
Chronic use of any concomitant medication which has a significant potential for interaction with MTX (e.g. sulfa antibiotics, chronic non-steroidal anti-inflammatory (NSAID) use)
History of tuberculosis, opportunistic infections, or any active infection at screening
Elevated liver enzymes (AST, ALT, ≥1.5 times normal at screening)
Serum creatinine ≥1.5 (at screening)
Any other laboratory abnormality that would pose a concern for the investigator
Daily alcohol use or consumption of more than four alcoholic drinks (4 ounces) in one 24 hour period
Patients who test positive for hepatitis B or C exposure (previous vaccination to Hepatitis B is allowed)
Cancer within the last five years is exclusionary with the exception of treated cutaneous basal cell carcinoma or squamous cell carcinoma or low-grade cervical intraepithelial neoplasia.
Any patient that is deemed by the investigator to be at a safety risk for the intervention in this trial.