Study to Assess if ABP798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Rituximab



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 80
Updated:10/14/2018
Start Date:May 17, 2016
End Date:October 8, 2018

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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 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:

- 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

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:

- 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
We found this trial at
28
sites
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Vero Beach, FL
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Aventura, FL
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from
Carrollton, TX
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Charleston, South Carolina 29412
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from
Charleston, SC
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Charlotte, North Carolina 28207
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from
Charlotte, NC
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from
Dallas, TX
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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from
Edgewater, FL
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from
Flowood, MS
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from
Hialeah, FL
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Idaho Falls, ID
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Lansing, MI
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Las Vegas, NV
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League City, TX
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Lexington, KY
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Los Angeles, CA
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Memphis, TN
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Mesquite, TX
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Oklahoma City, OK
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Olympia, WA
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Orangeburg, SC
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Orlando, FL
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Plano, TX
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Sofia,
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Spokane, WA
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Thousand Oaks, California 91360
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Thousand Oaks, CA
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Tuscaloosa, AL
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Upland, CA
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