Auto-injector Real Life Handling in Patients

Exclusion Criteria

• •Patients with previous experience of self-administering medications using an autoinjector or pen (either marketed or investigational).
• •Patients who upon initial training are determined not to be acceptable candidates for self-administration.
• •RA with significant secondary involvement of any systemic organ (including but not limited to vasculitis, pulmonary fibrosis).
• •Prior treatment with more than 1 biologic or 1 protein kinase inhibitor DMARD for RA.
• •Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab.
• •Prior treatment with TNF inhibitors for RA with lack of efficacy as per clinical judgment.
• •Treatment with DMARD other than MTX within 4 weeks prior to screening (8 weeks in case of leflunomide and azathioprine).
• •History of or current inflammatory joint disease other than RA (eg, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (eg, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or any overlap syndrome).
• •Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement), within 8 weeks prior to informed consent or planned during the study, or history of infected joint prosthesis within 5 years.
• •Pregnancy or breast feeding.
• •Significant cardiac (eg, New York Heart Association ≥ III) or pulmonary disease (including obstructive pulmonary disease).
• •Evidence of clinically significant uncontrolled concomitant disease (cardiac, renal, hepatic, pulmonary, metabolic, or gastro-intestinal) which in the Investigator's or medical monitor's opinion would preclude patient participation.
• •Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection.
• •Patient has an active and serious infection or history of infections as follows:
• •Any active infection:
• •For which non-systemic anti-infectives were used within 4 weeks prior to Day 0 (BL). Note: patients receiving topical antibiotics for facial acne do not need to be excluded.
• •Which required hospitalization or systemic anti-infective within 8 weeks prior to Day 0 (BL).
• •Recurrent or chronic infections or other active infection that, in the opinion of the Investigator or designee, might cause this study to be detrimental to the patient.
• •Invasive fungal infection or mycobacterial infection.
• •Opportunistic infections, such as listeriosis, legionellosis, or pneumocystis.
• •Patient has a history of malignancy within 5 years except for adequately treated cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
• •Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments.
• •Has evidence (as assessed by the Investigator or designee using good clinical judgment) of active substance abuse (alcohol or drugs) within 6 months of Screening that may impact patient's ability to participate in the study.
• •Patient has a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to active substance or to any of the excipients of Humira or AVT02.
• •Treatment with any investigational agent 90 days prior to informed consent or 5 halflives of the investigational drug (whichever is longer) and unwilling to undergo washout.
• •Previous treatment with any cell-depleting therapies, excluding cyclosporine or MTX, within previous 12 months, including investigational agents. Patients who have received cyclosporine, leflunomide, cyclophosphamide, or azathioprine in the past must have recovered from all drugrelated adverse events (AEs).
• •Patient has received live or attenuated vaccines during the 4 weeks prior to Day 0 (BL) or has the intention of receiving a live or attenuated vaccine at any time during the study.
• •Intra-articular or parenteral glucocorticoids within 4 weeks prior to informed consent.
• •Positive tests for HIV, hepatitis B surface antigen, or hepatitis C serology.
• •Hemoglobin \< 8.0 g/dL.
• •Absolute Neutrophil Count \< 1500 cells/mm3.
• •Absolute Lymphocyte Count \< 800 cells/mm3.
• •Platelet count \< 100 000 mm3.
• •Aspartate aminotransferase and/or alanine aminotransferase that is persistently ≥ 2 × the upper limit of normal. (Persistently indicates at least on 2 occasions separated by a number of days).
• •Creatinine clearance \< 50 mL/min (Cockcroft-Gault formula).