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
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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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								Upland, California 91786			
	
			
					Principal Investigator: Eric Lee
			
						
										Phone: 909-296-8700
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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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