Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate 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:May 2016
End Date:May 2020

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A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate 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 methotrexate (MTX).

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 MTX. 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. Adalimumab 40 mg q2w SC has been
included as the active comparator for assay sensitivity and non inferiority evaluations.

Inclusion 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 12 weeks prior to Screening.

- Inadequate response to 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 intolerant 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

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)

- Prior use of bDMARDs

- 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

- 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 1.5 years 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

- Uncontrolled diabetes mellitus

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

- Female subjects who are pregnant, currently lactating

- Female subjects of childbearing potential 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,
adalimumab, or placebo

- Other exclusion criteria may apply
We found this trial at
100
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922 Southwest 82nd Avenue
Miami, Florida 33144
Principal Investigator: Nayvis Iglesias
Phone: 305-677-9267
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Albuquerque, New Mexico 87108
Principal Investigator: Michael McGuire
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Amarillo, Texas
Principal Investigator: Constantine Saadeh
Phone: 806-353-7000
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Austin, Texas 78731
Principal Investigator: Tina Bunch
Phone: 512-344-0362
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Bahia Blanca, Buenos Aires
Principal Investigator: Fabian Risueño
Phone: +542914557273
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Baytown, Texas 77521
Principal Investigator: Sabeen Najam
Phone: 832-672-7973
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3406 College Street
Beaumont, Texas 77701
Phone: 409-813-1677
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10700 Stancliff Road
Beaumont, Texas 77702
Principal Investigator: Vijay Kumar
Phone: 713-333-9323
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Boca Raton, Florida
Principal Investigator: Joseph Forstot
Phone: 561-361-6547
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Boise, Idaho
Principal Investigator: Mark Turner
Phone: 208-377-8653
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Bowling Green, Kentucky 42101
Principal Investigator: Asad Fraser
Phone: 270-393-2786
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Chesapeake, Virginia 23320
Principal Investigator: Roger Lidman
Phone: 757-461-3400
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Joel Block
Phone: 312-942-8268
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Covina, California 91723
Phone: 626-966-1909
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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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Duncansville, Pennsylvania 16635
Principal Investigator: Frederick Murphy
Phone: 814-693-0300
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El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao
Phone: 619-334-4735
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Escondido, California 92025
Phone: 760-999-2011
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215 South Hickory Street
Escondido, California 92025
Principal Investigator: Tania Rivera
Phone: 858-336-2810
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Evansville, Indiana 47713
Phone: 812-426-9576
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Frederick, Maryland 21702
Principal Investigator: Nathan Wei
Phone: 301-694-5800
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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
Phone: 714-626-8650
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961 Smoky Mountain Springs # A
Gainesville, Georgia 30501
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Glendale, Arizona 85304
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Glendale, Arizona 85304
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Grand Blanc, Michigan 48439
Principal Investigator: Ali Karrar
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Grapevine, Texas 76051
Principal Investigator: Dhiman Basu
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Greensboro, North Carolina 27408
Principal Investigator: Mishra Nilamadhab
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
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Hamden, Connecticut 06518
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Principal Investigator: Gilberto Perez
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Principal Investigator: Ratinder Kaur
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Houston, Texas 77004
Principal Investigator: Samuel Pegram
Phone: 713-341-5930
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Houston, Texas 77004
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Houston, Texas
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Houston, Texas 77070
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Houston, Texas 77024
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6707 Sterling Ridge Drive
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Huntsville, Alabama 35801
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Idaho Falls, Idaho 83404
Principal Investigator: Craig Scoville
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Kalispell, Montana 59901
Principal Investigator: Roger Diegel
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Kansas City, Kansas
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La Palma, California 90623
Principal Investigator: Gerald Ho
Phone: 562-867-8195
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1003 Olde Waterford Way
Leland, North Carolina 28451
Principal Investigator: David Snow
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Lewes, Delaware 19958
Phone: 302-644-2633
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Little Rock, Arkansas 72205
Principal Investigator: Cummins Lue
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Los Alamitos, California 90720
Principal Investigator: Rebekah Neal
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Lubbock, Texas 79424
Principal Investigator: Naga Bushan
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Lubbock, Texas 79410
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Marietta, Georgia 30060
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Mesa, Arizona 85202
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Miami, Florida 33126
Principal Investigator: Henry Paez
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Miami, Florida 33135
Principal Investigator: Mark Kutner
Phone: 305-631-6704
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101 3rd Avenue Southwest
Minot, North Dakota 58701
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Monroe, Louisiana 71203
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Nashville, Tennessee 37203
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Nassau Bay, Texas 77058
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New Port Richey, Florida 34652
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New York, New York 10065
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Newark, Delaware 19713
Principal Investigator: Sheerin Javed
Phone: 302-633-9033
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North Charleston, South Carolina 29406
Principal Investigator: William Edwards
Phone: 843-572-4840
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Principal Investigator: William Schnitz
Phone: 405-602-3927
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Oklahoma City, Oklahoma 73103
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1310 West Stewart Drive
Orange, California 92868
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Orange Park, Florida 32073
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Orlando, Florida 32804
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Owensboro, Kentucky 42303
Principal Investigator: David Johnson
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Palm Harbor, Florida 34684
Principal Investigator: Anthony Sebba
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Palm Harbor, Florida 34684
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Pembroke Pines, Florida 33026
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Perrysburg, Ohio 43551
Principal Investigator: Edward Goldberger
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Philadelphia, Pennsylvania 19152
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Phoenix, Arizona 85037
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Portland, Maine 04102
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Reno, Nevada 89503
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7117 Brockton Avenue
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Saint Louis, Missouri 63128
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1740 Union Carbide Drive
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Spokane, Washington 99204
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Springfield, Illinois 62703
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Tampa, Florida 33613
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Tomball, Texas 77375
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Trumbull, Connecticut 06611
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Tupelo, Mississippi 38801
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Vancouver, Washington 98664
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Venice, Florida
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23101 Sherman Place
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Wheaton, Maryland 20902
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Wichita, Kansas 67214
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Wilmington, North Carolina 28401
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10857 Kuykendahl Road
Woodville, Texas 77382
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