Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

Inclusion Criteria:

1. Men or women ≥ 18 and ≤ 80 years old

2. Subjects must be diagnosed with Rheumatoid Arthritis for at least 3 months before
baseline

3. Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and
baseline

4. Subjects must be taking MTX for ≥ 12 consecutive weeks and on a stable dose of 7.5 to
25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain
on stable dose throughout the study

5. Subject has no known history of active tuberculosis

Exclusion Criteria:

1. Class IV RA, Felty's syndrome or history of prosthetic or native joint infection

2. Major chronic inflammatory disease or connective tissue disease other than RA, with
the exception of secondary Sjögren's syndrome

3. Prior use of 2 or more biologic therapies for RA

4. Previous receipt of Humira® (adalimumab) or a biosimilar of adalimumab

5. Ongoing use of prohibited treatments

Other Inclusion/Exclusion criteria may apply