Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:12/5/2018
Start Date:December 2016
End Date:January 2020

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A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-α) Inhibitor Therapy

The purpose of this study is to determine how safe and effective the study drug Olokizumab
is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully
responding to treatment with an existing medication called a tumour necrosis factor alpha
inhibitor

The goal of this Phase III study is to assess the safety, tolerability, and efficacy of OKZ
in subjects with moderately to severely active RA who have responded inadequately to TNFi
therapy. The primary endpoint of the trial is at Week 12. Olokizumab is expected to reduce
the disease activity and improve physical function. The study is expected to provide safety
information in a large group of subjects over at least a 24 week period.

Inclusion Criteria:

Subjects may be enrolled in the study only if they meet all of the following criteria.

- Subjects willing and able to sign informed consent

- Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised
classification criteria for RA for at least 24 weeks prior to Screening.

- Treatment with MTX for at least 12 weeks prior to Screening at a dose of 15 to 25
mg/week (or ≥10 mg/week if there is documented intolerance to higher doses)

- The dose and means of administering MTX must have been stable for at least 6
weeks prior to Screening.

- Subjects must be willing to take folic acid or equivalent throughout the study.

- Subjects must have moderately to severely active RA disease as defined by all of the
following:

- ≥6 tender joints (68 joint count) at Screening and baseline; and

- ≥6 swollen joints (66 joint count) at Screening and baseline; and

- CRP above ULN at Screening based on the central laboratory results.

- Subjects must have a documented inadequate response to treatment (i.e., TNFi failure)
with ≥1 licensed TNFi following at least 12 weeks of therapy with that agent.

Exclusion Criteria:

- Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g.,
gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile
idiopathic arthritis, or systemic lupus erythematosus)

- Prior exposure to any licensed or investigational compound directly or indirectly
targeting IL 6 or IL 6R (including tofacitinib or other Janus kinases and spleen
tyrosine kinase [SYK] inhibitors)

- Prior treatment with cell depleting therapies including anti CD20 or investigational
agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19) with the exception
of rituximab, which is allowed if it was discontinued at least 24 weeks prior to
baseline (rituximab should not be discontinued to facilitate a subject's participation
in the study, but should instead have been previously discontinued as part of a
subject's medical management of RA).

- Prior use of bDMARDs, within the following windows prior to baseline (bDMARDs should
not be discontinued to facilitate a subject's participation in the study, but should
instead have been previously discontinued as part of a subject's medical management of
RA):

1. 4 weeks for etanercept and anakinra

2. 8 weeks for infliximab

3. 10 weeks for adalimumab, certolizumab, and golimumab

4. 12 weeks for abatacept

- Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or
change in dosage within 2 weeks prior to baseline

- Prior history of no response to hydroxychloroquine and sulfasalazine

- Prior use of cDMARDs (other than MTX) within the following windows prior to baseline
(cDMARDs should not be discontinued to facilitate a subject's participation in the
study, but should instead have been previously discontinued as part of a subject's
medical management of RA):

1. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine,
chloroquine, gold, penicillamine, minocycline, or doxycycline

2. 12 weeks for leflunomide unless the subject has completed the following
elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a
dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a
dosage of 50 grams 4 times daily for at least 24 hours

3. 24 weeks for cyclophosphamide

- Participation in any other investigational drug study within 30 days or 5 times the
terminal half-life of the investigational drug, whichever is longer, prior to baseline

- Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to
baseline

- Use of non steroidal anti inflammatory drugs (NSAIDs) on unstable dose or switching of
NSAIDs within 2 weeks prior to baseline

- Previous participation in this study (randomized) or another study of OKZ

- Abnormal laboratory values

- Subjects with concurrent acute or chronic viral Hepatitis B or C infection

- Subjects with HIV infection

- Subjects with:

1. Current active TB disease or a history of active TB disease.

2. Close contact with an individual with active TB within 1.5yrs prior to Screening

3. History of untreated latent TB infection (LTBI), regardless of IGRA result at
Screening

4. Positive interferon-gamma release assay (IGRA) result at Screening. If
indeterminate, the IGRA can be repeated once during the Screening Period. If
there is a second indeterminate result, the subject will be excluded.

- Concurrent malignancy or a history of malignancy within the last 5 years

- History of chronic alcohol or drug abuse as judged by the Investigator

- Female subjects who are pregnant, currently lactating,

- Female subjects of childbearing who are not willing to use a highly effective method
of contraception during the study OR Male subjects with partners of childbearing
potential not willing to use a highly effective method of contraception during the
study.

- Subjects with a known hypersensitivity to any component of the OKZ drug product or
placebo

- Other exclusion criteria may apply
We found this trial at
66
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101 3rd Avenue Southwest
Minot, North Dakota 58701
Principal Investigator: Erdal Diri
Phone: 701-857-2510
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: Mark Genovese
Phone: 650-498-4528
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Albany, New York 12206
Principal Investigator: Joel Kremer
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Albuquerque, New Mexico 87108
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Amarillo, Texas
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Austin, Texas 78731
Principal Investigator: Tina Bunch
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Bahia Blanca, Buenos Aires
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Baytown, Texas 77521
Principal Investigator: Sabeen Najam
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Boca Raton, Florida
Principal Investigator: Joseph Forstot
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Bowling Green, Kentucky 42101
Principal Investigator: Asad Fraser
Phone: 270-943-1302
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Charleston, South Carolina 29406
Principal Investigator: William Edwards
Phone: 843-572-4840
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Chesapeake, Virginia 23320
Principal Investigator: Roger Lidman
Phone: 757-461-3400
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Cincinnati, Ohio 45219
Principal Investigator: Michael Luggen
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Covina, California 91723
Principal Investigator: Samy Metyas
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Cumberland, Maryland 21502
Principal Investigator: Steven Klein
Phone: 301-724-4337
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Dayton, Ohio 45417
Principal Investigator: Sanford Wolfe
Phone: 937-223-4229
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Denver, Colorado 80230
Principal Investigator: Christopher Antolini
Phone: 303-394-2828
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El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao
Phone: 619-334-4735
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Freehold, New Jersey 07728
Principal Investigator: Hisham El-Kadi
Phone: 732-780-7650
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2141 North Harbor Boulevard
Fullerton, California 92835
Principal Investigator: Jay Kim
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961 Smoky Mountain Springs # A
Gainesville, Georgia 30501
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Glendale, Arizona 85304
Principal Investigator: Saima Chohan
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Grapevine, Texas 76051
Principal Investigator: Dhiman Basu
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Greensboro, North Carolina 27408
Principal Investigator: Nilamadhab Mishra
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
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Hemet, California 92453
Principal Investigator: Chandrakant Mehta
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Hot Springs, Arkansas 71913
Principal Investigator: Ratinder Kaur
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Houston, Texas 77004
Principal Investigator: Samuel Pegram
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Houston, Texas 77004
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Houston, Texas
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Houston, Texas 77098
Principal Investigator: Asif Cochinwala
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Houston, Texas 77070
Principal Investigator: Qaiser Rehman
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Houston, Texas 77024
Principal Investigator: Dale Halter
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Huntsville, Alabama 35801
Principal Investigator: William Shergy
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Idaho Falls, Idaho 83404
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Kalispell, Montana 59901
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Kansas City, Kansas
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Lakewood, California 90712
Principal Investigator: Gerald Ho
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1003 Olde Waterford Way
Leland, North Carolina 28451
Principal Investigator: David Snow
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Little Rock, Arkansas 72205
Principal Investigator: Lue Cummins
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Lubbock, Texas 79424
Principal Investigator: Jitendra Vasandani
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Meridian, Idaho 83642
Principal Investigator: Mark Turner
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Miami, Florida 33135
Principal Investigator: Mark Kutner
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Monroe, Louisiana 71203
Principal Investigator: Jyothi Mallepalli
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Nassau Bay, Texas 77058
Principal Investigator: Prashanth Sunkureddi
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New York, New York 10065
Principal Investigator: David Goddard
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Newark, Delaware 19713
Principal Investigator: Sheerin Javed
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Omaha, Nebraska 68114
Principal Investigator: William Palmer
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Orlando, Florida 32804
Principal Investigator: Kwabena Ayesu
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Owensboro, Kentucky 42303
Principal Investigator: David Johnson
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Pembroke Pines, Florida 33026
Principal Investigator: Jeanne-Elyse Cedeno
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Perrysburg, Ohio 43551
Principal Investigator: Edward Goldberger
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Philadelphia, Pennsylvania 19152
Principal Investigator: James Udell
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7117 Brockton Avenue
Riverside, California 92506
Principal Investigator: Andre Babajanians
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San Antonio, Texas 78240
Principal Investigator: Alex De Jesus
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San Leandro, California 94578
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Santa Monica, California 90404
Principal Investigator: Orrin Troum
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South Charleston, West Virginia 25309
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Tampa, Florida 33613
Principal Investigator: Harris McIlwain
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Upland, California 91786
Principal Investigator: Eric Lee
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Wheaton, Maryland 20902
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Whittier, California 90606
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Wilmington, North Carolina 28401
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10857 Kuykendahl Road
Woodville, Texas 77382
Principal Investigator: Tamar Brionez
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Worcester, Massachusetts 01610
Principal Investigator: Charles Birbara
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