Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Colitis, Ulcerative
Interventions
BIOLOGICAL

Anrukinzumab

200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

BIOLOGICAL

Anrukinzumab

200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

BIOLOGICAL

Anrukinzumab

200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.

OTHER

placebo

200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12

Trial Locations (76)

1090

AKH Wien Universitaetsklinik fuer Innere Medizin III, Vienna

1125

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly, Budapest

1136

Pannonia Maganorvosi Centrum Kft., Budapest

1606

MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia, Sofia

1750

DKTs Sveta Anna, Gastroenterologichen cabinet, Sofia

3100

Landesklinikum St. Poelten, Sankt Pölten

4020

Krankenhaus der Elisabethinen Linz GmbH, Linz

7002

MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie, Rousse

7100

Clinfan Kft., Szekszárd

10117

Charite - Campus Berlin Mitte, Berlin

12601

Premier Medical Group of the Hudson Valley, Poughkeepsie

24105

Universitaetsklinikum Schleswig-Holstein, Campus Kiel, Kiel

27103

Piedmont Gastroenterology Specialists, Winston-Salem

PMG Research of Winston-Salem, Winston-Salem

28007

Hospital General Universitario Gregorio Marañon, Madrid

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

30067

GI Diagnostics, Marietta

32423

Gastroenterologische Gemeinschaftspraxis Minden, Minden

32771

International Clinical Research - US, LLC, Sanford

35233

The Kirkland Clinic, Birmingham

UAB Hospital, Birmingham

35249

UAB Hospital Department of Pharmacy, Birmingham

35294

Administrative Offices, Birmingham

UAB ACIP, Birmingham

37203

Centennial Medical Center Physicians Park, Nashville

Centennial Medical Center Tower Medical Imaging, Nashville

Columbia Medical Group - The First Clinic Inc., Nashville

Radiology Alliance, Nashville

38120

The West Clinic, Memphis

38138

Memphis Gastroenterology Group, PC, Germantown

38801

Digestive Health Specialists, PA, Tupelo

North Mississippi Medical Center, Tupelo

39202

Gastrointestinal Associates, PA, Jackson

Gastrointestional Associates, PA, Jackson

39216

St. Dominic Hospital, Jackson

44093

CHU Hotel-Dieu, Nantes

44106

University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease, Cleveland

69120

Universitaetsklinikum Heidelberg, Heidelberg

73103

Wheeler and Stuckey, Inc., Oklahoma City

73104

Oklahoma Foundation for Digestive Research, Oklahoma City

OU Physicians Building, Oklahoma City

77081

Texas Center for Drug Development, Inc., Houston

78229

Cardiology Clinic of San Antonio, San Antonio

Gastroenterology Research of San Antonio, San Antonio

San Antonio Endoscopy Center, San Antonio

78681

Austin Gastroenterology, PA, Round Rocks

78705

Professional Quality Research, Inc., Austin

78757

Austin Endoscopy Center, Austin

Austin Gastroenterology, PA, Austin

80054

CHU Hopital Nord, Amiens

84084

RGL Medical Services, Salt Lake City

84102

Alpine Medical Group, Salt Lake City

84107

Wasatch Clinical Research, Salt Lake City

84123

CNS Pharmacy, Murray

84124

Wasatch Endoscopy Center, Salt Lake City

84132

University of Utah Hospital, Salt Lake City

85006

Arizona Surgical Center, Phoenix

85013

Dedicated Phase I, Inc., Phoenix

92110

Hopital Beaujon, Clichy

92705

West Coast Radiology Center, Santa Ana

92801

AGMG Endoscopy Center, Anaheim

Anaheim Clinical Trials, LLC, Anaheim

06518

Endoscopy Center of Connecticut, LLC, Hamden

Gastroenterology Center of Connecticut, PC, Hamden

Medical Research Center of Connecticut, LLC, Hamden

T2N 4Z6

Heritage Medical Research Clinic - University of Calgary, Calgary

V5Z 1M9

Vancouver Coastal Health - Vancouver General Hospital, Vancouver

Vancouver General Hospital - The Gordon and Leslie Diamond Centre, Vancouver

K7L 5G2

The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston, Kingston

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

1081 HV

VU Medisch Centrum, Amsterdam

1105 AZ

Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology, Amsterdam

6229 HX

Academisch Ziekenhuis Maastricht, Maastricht

02-507

Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii, Warsaw

010816

Sectia Clinica Medicina Interna II, Bucharest

08036

Hospital Clinic I Provincial de Barcelona, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01284062 - Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients | Biotech Hunter | Biotech Hunter