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 |
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.
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.
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
103
sites
Upland, California 91786
Principal Investigator: Eric Lee
Phone: 909-296-8700
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2128 W Flagler St # 201
Miami, Florida 33144
Miami, Florida 33144
Principal Investigator: Mark Kutner
Phone: 305-631-6704
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Albany, New York 12206
Principal Investigator: Joe Kremer
Phone: 518-489-4471
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Albuquerque, New Mexico 87108
Principal Investigator: Michael McGuire
Phone: 505-348-9500
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Amarillo, Texas 79124
Principal Investigator: Constantine Saadeh
Phone: 806-353-7000
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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: 281-422-7179
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3406 College Street
Beaumont, Texas 77701
Beaumont, Texas 77701
Principal Investigator: Leslie Goodman
Phone: 409-813-1677
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10700 Stancliff Road
Beaumont, Texas 77702
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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Bowling Green, Kentucky 42101
Principal Investigator: Asad Fraser
Phone: 270-943-1302
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Brooklyn, New York 11201
Principal Investigator: David Goddard
Phone: 646-962-4650
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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
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
Phone: 513-559-2370
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Covina, California 91723
Principal Investigator: Samy Metyas
Phone: 626-966-1909
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Cumberland, Maryland 21502
Principal Investigator: Steven Klein
Phone: 301-724-4337
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Cypress, Texas 77429
Principal Investigator: Asif Cochinwala
Phone: 713-333-9323
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Delaware City, Delaware 19958
Principal Investigator: Jose Pando
Phone: 302-644-2633
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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
Principal Investigator: James Schultz
Phone: 760-999-2011
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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
Fullerton, California 92835
Principal Investigator: Jay Kim
Phone: 714-626-8650
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961 Smoky Mountain Springs # A
Gainesville, Georgia 30501
Gainesville, Georgia 30501
Principal Investigator: Marta Bognar
Phone: 770-531-3711
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Glendale, Arizona 85304
Principal Investigator: Ramina Jajoo
Phone: 480-626-6653
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Grand Blanc, Michigan 48439
Principal Investigator: Ali Karrar
Phone: 810-953-8700
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Grapevine, Texas 76051
Principal Investigator: Dhiman Basu
Phone: 972-299-8399
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Greensboro, North Carolina 27408
Principal Investigator: Angela Hawkes
Phone: 336-501-1761
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
Phone: 301-791-6680
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Hamden, Connecticut 06518
Principal Investigator: Deborah Desir
Phone: 203-281-5910
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Hialeah, Florida 33012
Principal Investigator: Gilberto Perez
Phone: 786-536-4177
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Hot Springs, Arkansas 71913
Principal Investigator: Ratinder Kaur
Phone: 501-520-5476
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Houston, Texas 77004
Principal Investigator: Jacqueline Vo
Phone: 281-481-8557
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Houston, Texas 77004
Principal Investigator: Samuel Pegram
Phone: 713-521-7865
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Houston, Texas 77070
Principal Investigator: Qaiser Rehman
Phone: 281-517-0550
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Houston, Texas 77024
Principal Investigator: Dale Halter
Phone: 713-988-2615
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Houston, Texas 77089
Principal Investigator: Michelle Eisenberg
Phone: 281-464-2300
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Huntsville, Alabama 35801
Principal Investigator: William Shergy
Phone: 256-265-6778
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Idaho Falls, Idaho 83404
Principal Investigator: Craig Scoville
Phone: 208-542-9080
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Kalispell, Montana 59901
Principal Investigator: Roger Diegel
Phone: 406-755-1460
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Kansas City, Kansas 66160
Principal Investigator: Herbert Lindsley
Phone: 913-588-6009
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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
Leland, North Carolina 28451
Principal Investigator: David Snow
Phone: 608-848-8900
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Lincoln, Nebraska 68512
Principal Investigator: Melvin Churchill
Phone: 402-420-1212
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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
Phone: 562-794-9801
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Lubbock, Texas 79424
Principal Investigator: Jitendra Vasandani
Phone: 806-993-1040
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Marietta, Georgia 30060
Principal Investigator: Roel Querubin
Phone: 770-667-0220
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Meridian, Idaho 83642
Principal Investigator: Mark Turner
Phone: 208-377-8653
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Mesa, Arizona 85202
Principal Investigator: Daniel Kreutz
Phone: 480-321-8580
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922 Southwest 82nd Avenue
Miami, Florida 33144
Miami, Florida 33144
Principal Investigator: Nayvis Iglesias
Phone: 305-677-9267
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101 3rd Avenue Southwest
Minot, North Dakota 58701
Minot, North Dakota 58701
Principal Investigator: Erdal Diri
Phone: 701-857-2510
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Monroe, Louisiana 71203
Principal Investigator: Jyothi Mallepalli
Phone: 318-388-5830
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Nashville, Tennessee 37203
Principal Investigator: Robert LaGrone
Phone: 615-433-5395
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Nassau Bay, Texas 77058
Principal Investigator: Prashanth Sunkureddi
Phone: 713-677-0086
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New Port Richey, Florida 34652
Principal Investigator: Farrukh Zaidi
Phone: 727-849-4131
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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: 843-572-1818
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
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
Principal Investigator: Christine Codding
Phone: 405-702-6770
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Omaha, Nebraska 68114
Principal Investigator: William Palmer
Phone: 402-934-1666
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Orange Park, Florida 32073
Principal Investigator: Meera Oza
Phone: 904-276-0001
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Orlando, Florida 32804
Principal Investigator: Kwabena Ayesu
Phone: 832-455-7017
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Owensboro, Kentucky 42303
Principal Investigator: David Johnson
Phone: 270-691-1827
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Palm Harbor, Florida 34684
Principal Investigator: Anthony Sebba
Phone: 727-210-2555
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Palm Harbor, Florida 34684
Principal Investigator: Karen Zagar
Phone: 727-789-2784
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Palo Alto, California 94304
Principal Investigator: Mark Genovese
Phone: 650-498-4528
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Pembroke Pines, Florida 33026
Principal Investigator: Jeanne-Elyse Cedeno
Phone: 954-842-3147
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Philadelphia, Pennsylvania 19152
Principal Investigator: James Udell
Phone: 215-725-1710
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Phoenix, Arizona 85037
Principal Investigator: Kenneth Lawlor
Phone: 602-386-4960
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Phoenix, Arizona 85032
Principal Investigator: Saima Chohan
Phone: 480-443-8400
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7117 Brockton Avenue
Riverside, California 92506
Riverside, California 92506
Principal Investigator: Andre Babajanians
Phone: 951-321-6473
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Saint Louis, Missouri 63128
Principal Investigator: Barbara Caciolo
Phone: 314-543-5225
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San Antonio, Texas 78240
Principal Investigator: Alex De Jesus
Phone: 210-762-6579
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San Diego, California 92122
Principal Investigator: Tania Rivera
Phone: 858-336-2810
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San Leandro, California 94578
Principal Investigator: Clark Neuwelt
Phone: 510-357-1303
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Santa Monica, California 90404
Principal Investigator: Orrin Troum
Phone: 310-449-1999
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Scottsdale, Arizona 85251
Principal Investigator: Gary Silverman
Phone: 480-946-4455
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1740 Union Carbide Drive
South Charleston, West Virginia 25309
South Charleston, West Virginia 25309
Principal Investigator: Suzanne Gharib
Phone: 304-389-4455
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Spokane, Washington 99204
Principal Investigator: Howard Kenney
Phone: 509-838-6500
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Sun City, Arizona 85351
Principal Investigator: Nehad Soloman
Phone: 602-386-4972
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Tampa, Florida 33613
Principal Investigator: Harris McIlwain
Phone: 813-345-2401
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6707 Sterling Ridge Drive
The Woodlands, Texas 77382
The Woodlands, Texas 77382
Principal Investigator: Tamar Brionez
Phone: 832-452-7249
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26963 Eckel Road
Toledo, Ohio 43606
Toledo, Ohio 43606
Principal Investigator: Edward Goldberger
Phone: 419-873-1532
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Tomball, Texas 77375
Principal Investigator: Shaikh Arif Ali
Phone: 281-517-0550
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Trumbull, Connecticut 06611
Principal Investigator: Geoffrey Gladstein
Phone: 203-374-9816
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Tupelo, Mississippi 38801
Principal Investigator: Charles King
Phone: 662-377-5131
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Venice, Florida
Principal Investigator: Jeffrey Kaine
Phone: 941-485-8314
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23101 Sherman Place
West Hills, California 91307
West Hills, California 91307
Principal Investigator: Nazanin Firooz
Phone: 818-598-0000
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Wheaton, Maryland 20902
Principal Investigator: Herbert Baraf
Phone: 301-942-6610
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Whittier, California 90606
Principal Investigator: Tien-I Karleen Su
Phone: 562-758-6600
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Wichita, Kansas 67214
Principal Investigator: Steen Mortensen
Phone: 316-274-8101
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