Lead Sponsor

Alvotech Swiss AG

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•Subjects diagnosed with active RA according to ACR/EULAR 2010 classification criteria
•Subjects diagnosed with moderately to severe active RA as defined by ≥ 6 swollen (out of 66) and ≥6 tender (out of 68) joint counts, CRP \>1mg/l and with at least one of positive rheumatoid factor, positive anti-citrullinated peptide antibodies and/or evidence of 1 joint erosion of hands, wrist of dominant hand or feet at screening
•Subjects must have taken methotrexate for ≥12 weeks

•Prior treatment with biologics or Janus kinase inhibitors that may be used as disease-modifying anti-rheumatic drugs
•Any past or concurrent medical conditions that could potentially increase the subject's risks or that would interfere with the study evaluation, procedures or study completion
•Major chronic inflammatory disease or connective tissue disease other than RA or any active autoimmune disease
•Presence of chronic obstructive pulmonary disease
•Presence of chronic heart failure NYHA class III or IV