Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Exclusion Criteria

• •1. Subject has any contraindications to MTX or ADA;
• •2. Subject has a previous failed response or poor tolerance to ADA;
• •3. Subject has a poorly controlled medical condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study;
• •4. Subject has a history of clinically significant hematologic, renal or liver disease;
• •5. Subject has a history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease;
• •6. Subject has evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix;
• •7. Subject has a history of listeriosis, histoplasmosis, untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous (iv) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit;
• •8. Subject is known to have immune deficiency, history of human immunodeficiency virus (HIV) or is immunocompromised;
• •9. Subject currently uses or plans to use anti-retroviral therapy at any time during the study;
• •10. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study or for 150 days after the last dose of study medication;
• •11. Subject has a history of clinically significant drug or alcohol usage in the last year or cannot maintain an alcohol intake of 30 g a day or less throughout the study (one standard drink is defined as 180 mL/6 oz (approx. 10 g) of wine, 360 mL/12 oz (approx. 15 g) of regular beer, or 45 mL/1.5 oz (approx. 10 g) of spirits;
• •12. Screening clinical laboratory analyses show any of the following abnormal laboratory results:
• •* Aspartate transaminase (AST) or alanine transaminase (ALT) \> 2x the upper limit of normal (ULN);
• •* Serum total bilirubin \> 1.5 mg/dL (\> 26 micromol/L), except for subjects with Gilbert's Syndrome;
• •* Creatinine \> 1.5 mg/dL (133 micromol/L) in subjects ≤ 65 years old and \> upper limit of normal range in subjects \> 65;
• •* Positive Hepatitis B or C serology indicative of previous or current infection.
• •13. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study;
• •14. The following treatments are prohibited for all subjects during the study:
• •* Phototherapy (ultraviolet A with psoralen \[PUVA\] within 4 weeks of the Baseline Visit and/or ultraviolet B (UVB) within 2 weeks of the Baseline Visit);
• •* Other biologic therapies (including any other anti-tumor necrosis factor \[TNF\]) within 4 weeks of the Baseline Visit;
• •* Any investigational agents of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Baseline visit ;
• •* Any other systemic drug therapies for psoriasis within 4 weeks of the Baseline Visit;
• •* Oral or injectable corticosteroids, new prescription topical therapies, or changes in the concentration of current prescription topical therapies (including corticosteroids) that are being used, within 2 weeks of the Baseline Visit. Subjects may continue using previously prescribed topical therapies (including corticosteroids) during the study.
• •15. Prior exposure to biologics that have a potential or known association with progressive multifocal leukoencephalopathy (PML), i.e., natalizumab (Tysabri®) or rituximab (Rituxan®);
• •16. Subjects with any active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study;