A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis
A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis
This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe RA.
This study will also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.
Inclusion Criteria:
Men or women ≥ 18 and ≤ 80 years old
Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before baseline
Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening:
Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study
Subject has no known history of active tuberculosis
Exclusion Criteria:
Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
Use of commercially available or investigational biologic therapies for RA as follows:
Previous receipt of rituximab or a biosimilar of rituximab
Other Inclusion/Exclusion criteria may apply
Sofia, Sofia 1233, Bulgaria
Sofia, Sofia 1612, Bulgaria
Budapest, Pest County 1083, Hungary