A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

PHASE2CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

March 20, 2012

Primary Completion Date

August 13, 2013

Study Completion Date

May 7, 2014

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

PF-05280586

1000 mg, IV on days 1 and 15

BIOLOGICAL

MabThera

1000 mg, IV on days 1 and 15

BIOLOGICAL

Rituxan

1000 mg, IV on days 1 and 15

Trial Locations (84)

3000

Dr. Jan Fourie Medical Centre, Dundee

4558

Rheumatology Research Unit, Maroochydore

5011

The Queen Elizabeth Hospital, Department of Rheumatology, Woodville South

7500

Panorama Medical Centre, Panorama

11021

North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical Immunology, Great Neck

14059

Schlosspark-Klinik GMBH, Internal Medicine II, Berlin

16635

Altoona Center for Clinical Research, Duncansville

19152

The Arthritis Group, Philadelphia

19610

Clinical Research Center of Reading, LLP, Wyomissing

21502

Klein & Associates, M.D., P.A., Cumberland

21740

Klein & Associates, M.D., P.A., Hagerstown

28210

Box Arthritis & Rheumatology of the Carolinas, PLLC, Charlotte

28601

Hickory Family Practice Associates, Hickory

28602

PMG Research of Hickory, LLC - PI's Main Office (Subject visit, IP Storage, Infusion, & Lab Draws), Hickory

PMG Research of Hickory, Hickory

32804

Arthritis Associates, Orlando

33612

University of South Florida - College of Medicine, Frank and Carol Morsani Center, Tampa

34270

Centro De Investigacion Y Atencion Integral Durango CIAID, Durango

35249

University of Alabama at Bermingham, Birmingham

35294

University of Alabama at Birmingham - Arthritis Clinical Intervention Program (ACIP) SRC 076, Birmingham

35801

Rheumatology Associates of North Alabama, PC, Huntsville

37343

Arthritis Associates, PLLC, Hixson

38305

Arthritis Clinic, Jackson

West Tennessee Research Institute, Jackson

40504

Bluegrass Community Research, Inc., Lexington

45219

Cincinnati Rheumatic Disease Study Group, Inc., Cincinnati

48910

Rheumatology/Arthritis Center, Lansing

49015

Bronson Internal Medicine & Rheumatology, Battle Creek

52621

The Chaim Sheba Medical Center Department of Internal Medicine B, Ramat Gan

60053

Illinois Bone and Joint Institute, Morton Grove

60153

Loyola Medical Medical Center Outpatient Center, Maywood

Loyola University Medical Center Pharmacy, Maywood

60181

Loyola Center for health at Oakbrook Terrace North, Oakbrook Terrace

60527

Loyola Center for Health at Burr Ridge, Burr Ridge

71913

Mercy Clinic Hot Springs Communities, Hot Springs

73103

Health Research of Oklahoma, Oklahoma City

75150

Southwest Rheumatology Research LLC., Mesquite

75231

Metroplex Clinical Research Center, Dallas

77004

Center For Clinical Trials Of Houston, Houston

78200

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C., San Luis Potosí City

85234

ArthroCare, Arthritis Care & Research, PC, Gilbert

89102

University Of Nevada School Of Medicine, Las Vegas

90095

Ronald Reagan UCLA Medical Center, Los Angeles

92260

Desert Medical Advances, Palm Desert

92270

Advances In Medicine, Rancho Mirage

190068

St. Petersburg state Healthcare lnstitution 'Clinical Rheumatology Hospital No25, Saint Petersburg

191014

Llc Ava-Peter, Saint Petersburg

420103

GBUZ City Clinical Hospital #7, Kazan'

443095

State Institute of Healthcare Samara Regional Clinical Hospital named after M.I.Kalinin, Samara

603005

State Budgetary Institution of Healthcare of Nizhegorodskiy Region, Nizhny Novgorod

630091

"LLC CDCR Healthy Joints", Novosibirsk

634063

"Regional State Budget Institution of Healthcare Tomsk Regional Clinical Hospital", Tomsk

650000

"State Institution of Healthcare Regional Clinical Hospital for Wars' Veterans", Kemerovo

90095-1670

UCLA David Geffen School of Medicine, Los Angeles

06611

New England Research Assoc. LLC, Trumbull

01605

Clinical Pharmacology Study Group, Worcester

UMass Memorial Medical Center - Memorial Campus, Worcester

UMass Memorial Medical Center-Rheumatology Center-Memorial Campus, Worcester

03756

Dartmouth Hitchcock Medical Center, Lebanon

03065

St. Vincent's Hospital (Melbourne), Fitzroy

G1V 3M7

Pharmacie Matte et Petit, Québec

G1W 4R4

Centre de Rhumatologie St-Louis, Québec

G5L 8W1

Centre de Rhumatologie de l'Est du Quebec, Rimouski

G5L IJ5

Clinique Medicale du Phare, Rimouski

G8Z 1Y2

Centre de Recherche Musculo-Squelettique, Trois-Rivières

Unknown

Clinica Medellin S.A Sede Centro, Medellín

Mix Supplier S.A, Medellín

Rodrigo Botero S.A.S., Medellín

Cediul S.A., Barranquilla

Centro de Reumatologia y Ortopedia, Barranquilla

Clinica Bonnadona - Prevenir S.A., Barranquilla

Clinica de la Costa Ltdz., Barranquilla

IPS Centro Integral de Reumatologia del Cairbe, CIRCARIBE S.A.S., Barranquilla

Sabbag Radiologos Ltda., Barranquilla

Cerid S.A., Barranquilla, Colombia

Congregacion de las Hemanas Franciscanas Misioneras de Maria Auxiliadora - Clinica La Asuncion, Barranquilla, Colombia

IPS Clinica General del Norte S.A., Barranquilla, Colombia

06700

Cliditer, S.A. de C.V., México

06726

Private Office, Guadalajara

LS9 7TF

Bexley Wing - St. James's University Hospital, Leeds

Pharmacy Dispensing - Bexley Wing - St. James's University Hospital, Leeds

LS1 3EX

Pharmacy Department, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds

LS7 4SA

"The University of Leeds,", Leeds

E11 1NR

Whipps Cross University Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01526057 - A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01) | Biotech Hunter | Biotech Hunter