A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:12/15/2018
Start Date:December 22, 2016
End Date:November 6, 2018

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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors

This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group,
multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in
participants with RA who are inadequately responding to standard-of-care (methotrexate and
anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate
efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the
option of continuing to the extension period of the study.


Inclusion Criteria:

- Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months
before screening

- Moderately to severely active RA as defined by at least 4/28 tender joints and at
least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2

- For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced
magnetic resonance imaging

- Participants must be taking stable dose of anti-TNF-alpha therapies

- Participants on stable oral glucocorticoids within 6 weeks of planned randomization

- Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up
to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID
use (on stable dose for ≥ 4 weeks)

Exclusion Criteria:

- Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks
or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned
randomization, or scheduled parenteral administrations during the study

- Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6
weeks prior to planned randomization

- Active inflammatory diseases of the joints not related to RA

- Systemic autoimmune disease other than RA

- Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16

- Active fibromyalgia that makes appropriate assessment of RA disease activity
challenging in the opinion of the Investigator

- RA participants functional status class IV according to the ACR 1991 criteria

- Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal
infections

- History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human
immunodeficiency virus (HIV) infection

- Any identified confirmed congenital or acquired immunodeficiency

- Abnormal laboratory values and liver function test

- Myocardial infarction within less than 6 months prior to participation in the study

- Severe central or peripheral nervous system diseases
We found this trial at
32
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Houston, Texas 77098
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Albuquerque, New Mexico
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Albuquerque, New Mexico 87102
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321 East 10th Street
Anniston, Alabama 36207
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6119 U.S. 11
Canton, New York 13617
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725 Uruguay
Cap fed, C1015ABO
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Charleston, South Carolina 29406
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1711 Saint Julian Place
Columbia, South Carolina 29204
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Corpus Christi, Texas 78404
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Covina, California 91723
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Dallas, Texas 75231
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Debary, FL
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Duncansville, Pennsylvania 16635
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Freehold, New Jersey 07728
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Freehold, NJ
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Glendale, AZ
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Hialeah, Florida 33015
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Hialeah, FL
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Houston, TX
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Jackson, Tennessee 38305
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Lakewood, California 90712
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1500 South Dobson Road
Mesa, Arizona 85202
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Mesquite, Texas 75150
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Middleburg Heights, Ohio 44130
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Ormond Beach, Florida
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Phoenix, AZ
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
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10701 Corporate Drive
Stafford, Texas 77477
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300 Pasteur Drive
Stanford, California 94304
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Toms River, New Jersey 08755
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442 Commons Way
Toms River, New Jersey 08755
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Wexford, PA
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Worcester, Massachusetts 01610
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