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
Duncansville, Pennsylvania 16635
2205
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from 98109
Duncansville, PA
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2724
mi
from 98109
Aventura, FL
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1667
mi
from 98109
Carrollton, TX
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Charleston, South Carolina 29412
2424
mi
from 98109
Charleston, SC
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Charlotte, North Carolina 28207
2283
mi
from 98109
Charlotte, NC
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1682
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from 98109
Dallas, TX
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2547
mi
from 98109
Edgewater, FL
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1985
mi
from 98109
Flowood, MS
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2725
mi
from 98109
Hialeah, FL
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573
mi
from 98109
Idaho Falls, ID
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1853
mi
from 98109
Lansing, MI
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872
mi
from 98109
Las Vegas, NV
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1915
mi
from 98109
League City, TX
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2005
mi
from 98109
Lexington, KY
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962
mi
from 98109
Los Angeles, CA
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1864
mi
from 98109
Memphis, TN
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1688
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from 98109
Mesquite, TX
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1523
mi
from 98109
Oklahoma City, OK
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48
mi
from 98109
Olympia, WA
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2351
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from 98109
Orangeburg, SC
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2544
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from 98109
Orlando, FL
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1673
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from 98109
Plano, TX
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?
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from 98109
Sofia,
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229
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from 98109
Spokane, WA
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Thousand Oaks, California 91360
946
mi
from 98109
Thousand Oaks, CA
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2058
mi
from 98109
Tuscaloosa, AL
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965
mi
from 98109
Upland, CA
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2633
mi
from 98109
Vero Beach, FL
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