Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

Completed · Phase 3

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT02792699

Run by

Amgen

People needed

311

Starts

2016-05-17

Expected to finish

2018-10-08

Last updated by the study team

2020-10-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr
• serum C-reactive protein (CRP) > 1.0 mg/dL
• 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

You may not qualify if…

• 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:
• anakinra, etanercept within 1 month prior to first dose of IP
• infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior to first dose of IP
• other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of IP
• Previous receipt of rituximab or a biosimilar of rituximab
• Other Inclusion/Exclusion criteria may apply

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Upland, California, United States
• Research Site — Aventura, Florida, United States
• Research Site — Edgewater, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Vero Beach, Florida, United States
• Research Site — Idaho Falls, Idaho, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Lansing, Michigan, United States
• Research Site — Flowood, Mississippi, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Orangeburg, South Carolina, United States
• Research Site — Summerville, South Carolina, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Carrollton, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — League City, Texas, United States
• Research Site — Mesquite, Texas, United States
• Research Site — Plano, Texas, United States
• Research Site — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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