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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Spokane, Washington 99204
Principal Investigator: Howard Kenney
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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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Amarillo, Texas 79124
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Austin, Texas 78731
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Bahia Blanca, Buenos Aires
Principal Investigator: Fabian Risueño
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Baytown, Texas 77521
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3406 College Street
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Principal Investigator: Leslie Goodman
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10700 Stancliff Road
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Principal Investigator: Vijay Kumar
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Bowling Green, Kentucky 42101
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Brooklyn, New York 11201
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Chesapeake, Virginia 23320
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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
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Covina, California 91723
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Cumberland, Maryland 21502
Principal Investigator: Steven Klein
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Cypress, Texas 77429
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Delaware City, Delaware 19958
Principal Investigator: Jose Pando
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Principal Investigator: Christopher Antolini
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Duncansville, Pennsylvania 16635
Principal Investigator: Frederick Murphy
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Frederick, Maryland 21702
Principal Investigator: Nathan Wei
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961 Smoky Mountain Springs # A
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Grand Blanc, Michigan 48439
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Grapevine, Texas 76051
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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
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Hemet, California 92453
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Houston, Texas 77004
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La Palma, California 90623
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1003 Olde Waterford Way
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Principal Investigator: David Snow
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Lincoln, Nebraska 68512
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Little Rock, Arkansas 72205
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Marietta, Georgia 30060
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Mesa, Arizona 85202
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101 3rd Avenue Southwest
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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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Palm Harbor, Florida 34684
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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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