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

Use our guide to learn which trials are right for you!

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
103
sites
Grand Blanc, Michigan 48439
Principal Investigator: Ali Karrar
Phone: 810-953-8700
?
mi
from
Grand Blanc, MI
Click here to add this to my saved trials
2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: Mark Kutner
Phone: 305-631-6704
?
mi
from
Miami, FL
Click here to add this to my saved trials
Albany, New York 12206
Principal Investigator: Joe Kremer
Phone: 518-489-4471
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
Principal Investigator: Michael McGuire
Phone: 505-348-9500
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Amarillo, Texas 79124
Principal Investigator: Constantine Saadeh
Phone: 806-353-7000
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Austin, Texas 78731
Principal Investigator: Tina Bunch
Phone: 512-344-0362
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bahia Blanca, Buenos Aires
Principal Investigator: Fabian Risueño
Phone: +542914557273
?
mi
from
Bahia Blanca,
Click here to add this to my saved trials
Baytown, Texas 77521
Principal Investigator: Sabeen Najam
Phone: 281-422-7179
?
mi
from
Baytown, TX
Click here to add this to my saved trials
3406 College Street
Beaumont, Texas 77701
Principal Investigator: Leslie Goodman
Phone: 409-813-1677
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
10700 Stancliff Road
Beaumont, Texas 77702
Principal Investigator: Vijay Kumar
Phone: 713-333-9323
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Boca Raton, Florida
Principal Investigator: Joseph Forstot
Phone: 561-361-6547
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Bowling Green, Kentucky 42101
Principal Investigator: Asad Fraser
Phone: 270-943-1302
?
mi
from
Bowling Green, KY
Click here to add this to my saved trials
Brooklyn, New York 11201
Principal Investigator: David Goddard
Phone: 646-962-4650
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Chesapeake, Virginia 23320
Principal Investigator: Roger Lidman
Phone: 757-461-3400
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45219
Principal Investigator: Michael Luggen
Phone: 513-559-2370
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Covina, California 91723
Principal Investigator: Samy Metyas
Phone: 626-966-1909
?
mi
from
Covina, CA
Click here to add this to my saved trials
Cumberland, Maryland 21502
Principal Investigator: Steven Klein
Phone: 301-724-4337
?
mi
from
Cumberland, MD
Click here to add this to my saved trials
Cypress, Texas 77429
Principal Investigator: Asif Cochinwala
Phone: 713-333-9323
?
mi
from
Cypress, TX
Click here to add this to my saved trials
Dayton, Ohio 45417
Principal Investigator: Sanford Wolfe
Phone: 937-223-4229
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Delaware City, Delaware 19958
Principal Investigator: Jose Pando
Phone: 302-644-2633
?
mi
from
Delaware City, DE
Click here to add this to my saved trials
Denver, Colorado 80230
Principal Investigator: Christopher Antolini
Phone: 303-394-2828
?
mi
from
Denver, CO
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
Principal Investigator: Frederick Murphy
Phone: 814-693-0300
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao
Phone: 619-334-4735
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
Escondido, California 92025
Principal Investigator: James Schultz
Phone: 760-999-2011
?
mi
from
Escondido, CA
Click here to add this to my saved trials
Frederick, Maryland 21702
Principal Investigator: Nathan Wei
Phone: 301-694-5800
?
mi
from
Frederick, MD
Click here to add this to my saved trials
Freehold, New Jersey 07728
Principal Investigator: Hisham El-Kadi
Phone: 732-780-7650
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
2141 North Harbor Boulevard
Fullerton, California 92835
Principal Investigator: Jay Kim
Phone: 714-626-8650
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
961 Smoky Mountain Springs # A
Gainesville, Georgia 30501
Principal Investigator: Marta Bognar
Phone: 770-531-3711
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Glendale, Arizona 85304
Principal Investigator: Ramina Jajoo
Phone: 480-626-6653
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Grapevine, Texas 76051
Principal Investigator: Dhiman Basu
Phone: 972-299-8399
?
mi
from
Grapevine, TX
Click here to add this to my saved trials
Greensboro, North Carolina 27408
Principal Investigator: Angela Hawkes
Phone: 336-501-1761
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
Phone: 301-791-6680
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
Hamden, Connecticut 06518
Principal Investigator: Deborah Desir
Phone: 203-281-5910
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Hemet, California 92453
Principal Investigator: Chandrakant Mehta
Phone: 951-652-5000
?
mi
from
Hemet, CA
Click here to add this to my saved trials
Hialeah, Florida 33012
Principal Investigator: Gilberto Perez
Phone: 786-536-4177
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
Principal Investigator: Ratinder Kaur
Phone: 501-520-5476
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
Houston, Texas 77004
Principal Investigator: Jacqueline Vo
Phone: 281-481-8557
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77004
Principal Investigator: Samuel Pegram
Phone: 713-521-7865
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas
Principal Investigator: Amber Khan
Phone: 281-422-7179
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77070
Principal Investigator: Qaiser Rehman
Phone: 281-517-0550
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77024
Principal Investigator: Dale Halter
Phone: 713-988-2615
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77089
Principal Investigator: Michelle Eisenberg
Phone: 281-464-2300
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
Principal Investigator: William Shergy
Phone: 256-265-6778
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Craig Scoville
Phone: 208-542-9080
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Kalispell, Montana 59901
Principal Investigator: Roger Diegel
Phone: 406-755-1460
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Kansas City, Kansas 66160
Principal Investigator: Herbert Lindsley
Phone: 913-588-6009
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
La Palma, California 90623
Principal Investigator: Gerald Ho
Phone: 562-867-8195
?
mi
from
La Palma, CA
Click here to add this to my saved trials
1003 Olde Waterford Way
Leland, North Carolina 28451
Principal Investigator: David Snow
Phone: 608-848-8900
?
mi
from
Leland, NC
Click here to add this to my saved trials
Lincoln, Nebraska 68512
Principal Investigator: Melvin Churchill
Phone: 402-420-1212
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Principal Investigator: Cummins Lue
Phone: 501-227-8000
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Alamitos, California 90720
Principal Investigator: Rebekah Neal-Kraal
Phone: 562-794-9801
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
Lubbock, Texas 79424
Principal Investigator: Jitendra Vasandani
Phone: 806-993-1040
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Roel Querubin
Phone: 770-667-0220
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Meridian, Idaho 83642
Principal Investigator: Mark Turner
Phone: 208-377-8653
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Mesa, Arizona 85202
Principal Investigator: Daniel Kreutz
Phone: 480-321-8580
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Miami, Florida 33126
Principal Investigator: Henry Paez
Phone: 305-262-4321
?
mi
from
Miami, FL
Click here to add this to my saved trials
922 Southwest 82nd Avenue
Miami, Florida 33144
Principal Investigator: Nayvis Iglesias
Phone: 305-677-9267
?
mi
from
Miami, FL
Click here to add this to my saved trials
101 3rd Avenue Southwest
Minot, North Dakota 58701
Principal Investigator: Erdal Diri
Phone: 701-857-2510
?
mi
from
Minot, ND
Click here to add this to my saved trials
Monroe, Louisiana 71203
Principal Investigator: Jyothi Mallepalli
Phone: 318-388-5830
?
mi
from
Monroe, LA
Click here to add this to my saved trials
Nashville, Tennessee 37203
Principal Investigator: Robert LaGrone
Phone: 615-433-5395
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nassau Bay, Texas 77058
Principal Investigator: Prashanth Sunkureddi
Phone: 713-677-0086
?
mi
from
Nassau Bay, TX
Click here to add this to my saved trials
New Port Richey, Florida 34652
Principal Investigator: Farrukh Zaidi
Phone: 727-849-4131
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Newark, Delaware 19713
Principal Investigator: Sheerin Javed
Phone: 302-633-9033
?
mi
from
Newark, DE
Click here to add this to my saved trials
North Charleston, South Carolina 29406
Principal Investigator: William Edwards
Phone: 843-572-1818
?
mi
from
North Charleston, SC
Click here to add this to my saved trials
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...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
Principal Investigator: Christine Codding
Phone: 405-702-6770
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68114
Principal Investigator: William Palmer
Phone: 402-934-1666
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange Park, Florida 32073
Principal Investigator: Meera Oza
Phone: 904-276-0001
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
Orlando, Florida 32804
Principal Investigator: Kwabena Ayesu
Phone: 832-455-7017
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Owensboro, Kentucky 42303
Principal Investigator: David Johnson
Phone: 270-691-1827
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Palm Harbor, Florida 34684
Principal Investigator: Anthony Sebba
Phone: 727-210-2555
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Palm Harbor, Florida 34684
Principal Investigator: Karen Zagar
Phone: 727-789-2784
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
Palo Alto, California 94304
Principal Investigator: Mark Genovese
Phone: 650-498-4528
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Pembroke Pines, Florida 33026
Principal Investigator: Jeanne-Elyse Cedeno
Phone: 954-842-3147
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19152
Principal Investigator: James Udell
Phone: 215-725-1710
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85037
Principal Investigator: Kenneth Lawlor
Phone: 602-386-4960
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85032
Principal Investigator: Saima Chohan
Phone: 480-443-8400
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Reno, Nevada 89503
Principal Investigator: Bryan Wolf
Phone: 775-800-6999
?
mi
from
Reno, NV
Click here to add this to my saved trials
7117 Brockton Avenue
Riverside, California 92506
Principal Investigator: Andre Babajanians
Phone: 951-321-6473
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63128
Principal Investigator: Barbara Caciolo
Phone: 314-543-5225
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78240
Principal Investigator: Alex De Jesus
Phone: 210-762-6579
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92122
Principal Investigator: Tania Rivera
Phone: 858-336-2810
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Leandro, California 94578
Principal Investigator: Clark Neuwelt
Phone: 510-357-1303
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
Santa Monica, California 90404
Principal Investigator: Orrin Troum
Phone: 310-449-1999
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Scottsdale, Arizona 85251
Principal Investigator: Gary Silverman
Phone: 480-946-4455
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
1740 Union Carbide Drive
South Charleston, West Virginia 25309
Principal Investigator: Suzanne Gharib
Phone: 304-389-4455
?
mi
from
South Charleston, WV
Click here to add this to my saved trials
Spokane, Washington 99204
Principal Investigator: Howard Kenney
Phone: 509-838-6500
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Sun City, Arizona 85351
Principal Investigator: Nehad Soloman
Phone: 602-386-4972
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
Tampa, Florida 33613
Principal Investigator: Harris McIlwain
Phone: 813-345-2401
?
mi
from
Tampa, FL
Click here to add this to my saved trials
6707 Sterling Ridge Drive
The Woodlands, Texas 77382
Principal Investigator: Tamar Brionez
Phone: 832-452-7249
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
26963 Eckel Road
Toledo, Ohio 43606
Principal Investigator: Edward Goldberger
Phone: 419-873-1532
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Tomball, Texas 77375
Principal Investigator: Shaikh Arif Ali
Phone: 281-517-0550
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Trumbull, Connecticut 06611
Principal Investigator: Geoffrey Gladstein
Phone: 203-374-9816
?
mi
from
Trumbull, CT
Click here to add this to my saved trials
Tupelo, Mississippi 38801
Principal Investigator: Charles King
Phone: 662-377-5131
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
Upland, California 91786
Principal Investigator: Eric Lee
Phone: 909-296-8700
?
mi
from
Upland, CA
Click here to add this to my saved trials
Venice, Florida
Principal Investigator: Jeffrey Kaine
Phone: 941-485-8314
?
mi
from
Venice, FL
Click here to add this to my saved trials
23101 Sherman Place
West Hills, California 91307
Principal Investigator: Nazanin Firooz
Phone: 818-598-0000
?
mi
from
West Hills, CA
Click here to add this to my saved trials
Wheaton, Maryland 20902
Principal Investigator: Herbert Baraf
Phone: 301-942-6610
?
mi
from
Wheaton, MD
Click here to add this to my saved trials
Whittier, California 90606
Principal Investigator: Tien-I Karleen Su
Phone: 562-758-6600
?
mi
from
Whittier, CA
Click here to add this to my saved trials
Wichita, Kansas 67214
Principal Investigator: Steen Mortensen
Phone: 316-274-8101
?
mi
from
Wichita, KS
Click here to add this to my saved trials