Evaluation of the Long Term Safety, Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ), in Subjects With Rheumatoid Arthritis (RA) Who Previously Completed 24 Weeks of Blinded Treatment in One of the Core Studies - CREDO 1, 2 or 3.



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:12/5/2018
Start Date:July 4, 2017
End Date:November 2021

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A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis

The purpose of the study is to evaluate how safe, how effective and how well tolerated, the
study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who
have previously taken part in and completed 24 weeks of blinded treatment in one of the core
studies - CREDO 1, 2 or 3.

The goal of this Phase III study is to evaluate the long-term safety, tolerability, and
efficacy of OKZ in subjects with moderately to severely active RA who previously completed 24
weeks of double-blind treatment with OKZ in the core studies. OKZ is expected to reduce the
disease activity and induce an improvement in physical function. The study is expected to
provide long-term safety information in a large group of subjects treated with OKZ for up to
106 weeks.

Inclusion Criteria:

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

1. Subject must be willing and able to sign informed consent

2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3
core studies (CL04041022, CL04041023, or CL04041025).

3. Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or
≥10 mg/week if there is documented intolerance to higher doses) during the core study
and plan to maintain the same dose and route of administration for additional 12 weeks

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

Exclusion Criteria:

1. Subject with any medically important condition in the core study (e.g., clinically
significant laboratory values, frequent AEs or SAEs, infection SAEs, and/or other
concurrent severe and/or uncontrolled medical condition) which would make this subject
unsuitable for inclusion in the open-label extension (OLE) study in the Investigator's
judgement.

2. Subject has evidence of active tuberculosis (TB)

3. Subject has planned surgery during the first 12 weeks of the OLE

4. Female subjects who are pregnant or who are planning to become pregnant during the
study or within 6 months of the last dose of study drug

5. 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.

6. Subject is unwilling or unable to follow the procedures outlined in the protocol

7. Other medical or psychiatric conditions, or lab abnormalities that may increase the
potential risk associated with study participation and administration of
investigational medicinal products (IMPs), or that may affect study results
interpretation and, as per Investigator's judgement, make the subject ineligible

The following restrictions may affect a subject's ability to participate in this study:

- Availability to attend visits according to the protocol within the allowed window
period

- Ability to perform self-administration of study drug and availability of caregiver to
administer study drug

- Concomitant medication restrictions as described in the Informed Consent Form and
protocol (water and concomitant medications are permitted) for at least 9 hours prior
to all study visits 8. Subject with a positive or repeated indeterminate
interferon-gamma release assay (IGRA) result at Week 22 of the core study

- Subjects may be enrolled in the OLE study if they fulfill all 3 of the following
criteria prior to the first dose of study treatment:

1. Active TB is ruled out by a certified TB specialist or pulmonologist who is
familiar with diagnosing and treating TB (as acceptable per local practice);

2. The subject starts prophylaxis for LTBI according to country-specific/Centers for
Disease Control and Prevention (CDC) guidelines (see Appendix 4 [Section 13.4])
(treatment with isoniazid for 6 months is not an appropriate

The Investigator (or designee) should review these restrictions with the subject during the
Screening Period to determine any potential challenges in the subject's ability to comply
with the protocol. Subjects not able to comply with the above mentioned restrictions should
not be enrolled into the study.
We found this trial at
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Bowling Green, Kentucky 42101
Principal Investigator: Asad Fraser
Phone: 270-943-1302
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2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: Mark Kutner
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Albany, New York 12206
Principal Investigator: Joe Kremer
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Albuquerque, New Mexico 87108
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Amarillo, Texas 79124
Principal Investigator: Constantine Saadeh
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Austin, Texas 78731
Principal Investigator: Tina Bunch
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Bahia Blanca, Buenos Aires
Principal Investigator: Fabian Risueño
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Baytown, Texas 77521
Principal Investigator: Sabeen Najam
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3406 College Street
Beaumont, Texas 77701
Principal Investigator: Leslie Goodman
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10700 Stancliff Road
Beaumont, Texas 77702
Principal Investigator: Vijay Kumar
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Boca Raton, Florida
Principal Investigator: Joseph Forstot
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Brooklyn, New York 11201
Principal Investigator: David Goddard
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Chesapeake, Virginia 23320
Principal Investigator: Roger Lidman
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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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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
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Cypress, Texas 77429
Principal Investigator: Asif Cochinwala
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Dayton, Ohio 45417
Principal Investigator: Sanford Wolfe
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Delaware City, Delaware 19958
Principal Investigator: Jose Pando
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Denver, Colorado 80230
Principal Investigator: Christopher Antolini
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Duncansville, Pennsylvania 16635
Principal Investigator: Frederick Murphy
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El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao
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Escondido, California 92025
Principal Investigator: James Schultz
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Frederick, Maryland 21702
Principal Investigator: Nathan Wei
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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
Principal Investigator: Marta Bognar
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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: Angela Hawkes
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
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Hamden, Connecticut 06518
Principal Investigator: Deborah Desir
Phone: 203-281-5910
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Hemet, California 92453
Principal Investigator: Chandrakant Mehta
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Hialeah, Florida 33012
Principal Investigator: Gilberto Perez
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Hot Springs, Arkansas 71913
Principal Investigator: Ratinder Kaur
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Houston, Texas 77004
Principal Investigator: Jacqueline Vo
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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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Houston, Texas 77089
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Huntsville, Alabama 35801
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Idaho Falls, Idaho 83404
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Kalispell, Montana 59901
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Kansas City, Kansas 66160
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La Palma, California 90623
Principal Investigator: Gerald Ho
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1003 Olde Waterford Way
Leland, North Carolina 28451
Principal Investigator: David Snow
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Lincoln, Nebraska 68512
Principal Investigator: Melvin Churchill
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Little Rock, Arkansas 72205
Principal Investigator: Cummins Lue
Phone: 501-227-8000
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Los Alamitos, California 90720
Principal Investigator: Rebekah Neal-Kraal
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Lubbock, Texas 79424
Principal Investigator: Jitendra Vasandani
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Marietta, Georgia 30060
Principal Investigator: Roel Querubin
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Meridian, Idaho 83642
Principal Investigator: Mark Turner
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Mesa, Arizona 85202
Principal Investigator: Daniel Kreutz
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Miami, Florida 33126
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922 Southwest 82nd Avenue
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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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Newark, Delaware 19713
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North Charleston, South Carolina 29406
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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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Omaha, Nebraska 68114
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Orange Park, Florida 32073
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Orlando, Florida 32804
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Owensboro, Kentucky 42303
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Palm Harbor, Florida 34684
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Palm Harbor, Florida 34684
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Palo Alto, California 94304
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Pembroke Pines, Florida 33026
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Phoenix, Arizona 85037
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Reno, Nevada 89503
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7117 Brockton Avenue
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1740 Union Carbide Drive
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Sun City, Arizona 85351
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Tampa, Florida 33613
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6707 Sterling Ridge Drive
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26963 Eckel Road
Toledo, Ohio 43606
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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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Upland, California 91786
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23101 Sherman Place
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Wichita, Kansas 67214
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