MedPath

A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

Phase 2
Completed
Conditions
Crohn's Disease
Interventions
Drug: PF-04236921 SC injection
Registration Number
NCT01287897
Lead Sponsor
Pfizer
Brief Summary

This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
250
Inclusion Criteria
  • Subjects must have failed or are intolerant to anti TNFs
  • hsCRP greater or equal to 5.0 mg/L
  • Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening
Exclusion Criteria
  • Pregnant or breastfeeding women
  • Crohn's Disease with active fistulae or abscess
  • History of diverticulitis or symptomatic diverticulosis
  • Abnormality in hematology or chemistry profiles at screening

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo- SC injectionPF-04236921 SC injection-
Drug Dose level 1 - SC injectionPF-04236921 SC injection-
Drug Dose level 2 - SC injectionPF-04236921 SC injection-
Primary Outcome Measures
NameTimeMethod
The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mgBaseline and Week 8

CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (\>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).

The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mgBaseline and Week 8

CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.

The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mgBaseline and Week 12

CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).

The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mgBaseline and Week 12

CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.

Secondary Outcome Measures
NameTimeMethod
The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mgBaseline and Weeks 2, 4, 6, and 10

CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.

The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mgBaseline and Weeks 2, 4, 6, 8, 10, and 12

CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).

The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mgBaseline and Weeks 2, 4, 6, 8, 10, and 12

CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.

The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mgBaseline and Weeks 2, 4, 6, and 10

CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).

The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mgBaseline and Weeks 2, 4, 6, 8, 10, and 12

CDAI remission rate was defined as an absolute CDAI score less than (\<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).

The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mgBaseline and Weeks 2, 4, 6, 8, 10, and 12

CDAI remission rate was defined as an absolute CDAI score \<150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.

Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mgBaseline and Weeks 2, 4, 6, 8, 10, and 12

CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).

Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mgBaseline and Weeks 2, 4, 6, 8, 10, and 12

CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.

Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40

The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) \>= 4.32.

Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40

The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.

Serum PF-04236921 Concentration Over TimeDay 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40
Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)

An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Trial Locations

Locations (190)

Digestive Disorders Associates

🇺🇸

Annapolis, Maryland, United States

An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw

🇧🇪

Roeselare, Belgium

Hepato-Gastroenterologie HK, s.r.o.

🇨🇿

Hradec Kralove, Czech Republic

Medial Pharma s.r.o.,

🇨🇿

Hradec Kralove, Czech Republic

The University of Chicago Medical Center

🇺🇸

Chicago, Illinois, United States

University of California - San Francisco

🇺🇸

San Francisco, California, United States

University of California San Francisco at Mount Zion

🇺🇸

San Francisco, California, United States

The University of Chicago Medical Center (Ucmc)

🇺🇸

Chicago, Illinois, United States

Houston Hospital for Specialized Surgery (Endoscopy Only)

🇺🇸

Houston, Texas, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

Baylor Clinic (Drug Storage)

🇺🇸

Houston, Texas, United States

Memorial Hermann Hospital

🇺🇸

Houston, Texas, United States

The University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

The University of Texas Medical School at Houston

🇺🇸

Houston, Texas, United States

Physicians Endoscopy Center (Colonoscopy)

🇺🇸

Houston, Texas, United States

Mount Sinai Hospital

🇨🇦

Toronto, Ontario, Canada

Kirurgisk Afdeling 0143

🇩🇰

Hilleroed, Denmark

Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital

🇩🇰

Aarhus C, Denmark

Gastroenheden

🇩🇰

Herlev, Denmark

Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi

🇮🇹

Bologna, Italy

Colonoscopy and X-rays: OU Physicians Building

🇺🇸

Oklahoma City, Oklahoma, United States

Hospital Nossa Senhora das Gracas

🇧🇷

Curitiba, Brazil

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Rocky Mountain Clinical Research, LLC

🇺🇸

Denver, Colorado, United States

Shaare Zedek Medical Center

🇮🇱

Jerusalem, Israel

Dept of Gastroenterology & Hepatology

🇮🇱

Kfar Saba, Israel

P3 Research Limited

🇳🇿

Wellington, New Zealand

Radiology Ltd

🇺🇸

Tucson, Arizona, United States

UCSF Endoscopy Unit at Mount Zion

🇺🇸

San Francisco, California, United States

Digestive Health Research Unit

🇺🇸

Scottsdale, Arizona, United States

UAB Hospital

🇺🇸

Birmingham, Alabama, United States

Rocky Mountain Gastroenterology

🇺🇸

Lakewood, Colorado, United States

Medical Research Center of Connecticut, LLC

🇺🇸

Hamden, Connecticut, United States

Clinical Research of West Florida, Inc.

🇺🇸

Clearwater, Florida, United States

Atlanta Endoscopy Center

🇺🇸

Decatur, Georgia, United States

Advanced Research Institute, Inc.

🇺🇸

New Port Richey, Florida, United States

Glenbrook Hospital

🇺🇸

Glenview, Illinois, United States

Decatur Health Imaging

🇺🇸

Decatur, Georgia, United States

Illinois Gastroenterology Group, LLC

🇺🇸

Arlington Heights, Illinois, United States

Disgestive Disorders Associates

🇺🇸

Annapolis, Maryland, United States

Utica Park Clinic X-Ray

🇺🇸

Tulsa, Oklahoma, United States

East Valley Endoscopy

🇺🇸

Grand Rapids, Michigan, United States

Weill Cornell Medical College of Cornell University-Greenberg

🇺🇸

New York, New York, United States

University Of Utah HSC

🇺🇸

Salt Lake City, Utah, United States

UZ Leuven Pharmacy

🇧🇪

Leuven, Belgium

Hospital Sao Lucas da PUCRS

🇧🇷

Porto Alegre, RS, Brazil

Aalborg Sygehus

🇩🇰

Aalborg, Denmark

Rigshospitalet

🇩🇰

Koebenhavn, Denmark

Medizinische Hochschule Hannover

🇩🇪

Hannover, Niedersachsen, Germany

Hopital de Brabois

🇫🇷

Vandoeuvre Les Nancy, France

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

🇭🇺

Debrecen, Hungary

New Cross Hospital

🇬🇧

Wolverhampton, United Kingdom

Royal Victoria Hospital

🇬🇧

Newcastle-upon-Tyne, United Kingdom

Hadassah Medical Center

🇮🇱

Jerusalem, Israel

Universitaetsspital Zuerich

🇨🇭

Zuerich, Switzerland

Institute of Gastroenterology

🇮🇱

Haifa, Israel

Hull and East Yorkshire Hospitals NHS Trust

🇬🇧

Hull, East Yorkshire, United Kingdom

Pharmacy Department

🇬🇧

Hull, United Kingdom

Rabin Medical Center, Beilinson Hospital

🇮🇱

Petach Tikva, Israel

Barts and The London NHS Trust

🇬🇧

London, United Kingdom

Royal Free Hospital (Royal Free London NHS Foundation Trust)

🇬🇧

London, United Kingdom

Addenbrooke's Hospital, Department of Gastroenterology

🇬🇧

Cambridge, United Kingdom

Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva

🇮🇹

San Giovanni Rotondo Fg, Foggia, Italy

Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust

🇬🇧

Wolverhampton, United Kingdom

Glasgow Royal Infirmary

🇬🇧

Glasgow, United Kingdom

Policlinico Tor Vergata

🇮🇹

Roma, Italy

Atlanta Center for Gastroenterology, P.C.

🇺🇸

Decatur, Georgia, United States

GI Diagnostics

🇺🇸

Marietta, Georgia, United States

Gastroenterology Associates

🇺🇸

Crystal River, Florida, United States

Nature Coast Clinical Research

🇺🇸

Inverness, Florida, United States

Commonwealth Clinical Studies

🇺🇸

Brockton, Massachusetts, United States

The University of Chicago Medical

🇺🇸

Chicago, Illinois, United States

The University Of Chicago

🇺🇸

Chicago, Illinois, United States

Adobe Clinical Research, Llc

🇺🇸

Tucson, Arizona, United States

Gastroenterology Center of Connecticut, PC

🇺🇸

Hamden, Connecticut, United States

Suncoast Endoscopy Center

🇺🇸

Inverness, Florida, United States

International Clinical Research - US, LLC

🇺🇸

Sanford, Florida, United States

Investigative Clinical Research

🇺🇸

Annapolis, Maryland, United States

St. Joseph Mercy Hospital

🇺🇸

Ypsilanti, Michigan, United States

Maryland Diagnostics & Therapeutic Endo Center

🇺🇸

Annapolis, Maryland, United States

Prima CARE, PC

🇺🇸

Fall River, Massachusetts, United States

Metro Health Hospital Endoscopy Unit

🇺🇸

Wyoming, Michigan, United States

Gastroenterology Associates of Western Michigan

🇺🇸

Wyoming, Michigan, United States

Huron Gastroenterology Associates

🇺🇸

Ypsilanti, Michigan, United States

Minnesota Gastroenterology, PA

🇺🇸

Plymouth, Minnesota, United States

Weill Cornell Medical College of Cornell University

🇺🇸

New York, New York, United States

New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

🇺🇸

New York, New York, United States

Present Chapman, Steinlauf and Marion

🇺🇸

New York, New York, United States

Mount Sinai School of Medicine

🇺🇸

New York, New York, United States

Arthur asher Kornbluth, MD PC

🇺🇸

New York, New York, United States

Weill Cornell Imaging at New York Presbyterian Hospital

🇺🇸

New York, New York, United States

New York Presbyterian Hospital

🇺🇸

New York, New York, United States

Oklahoma Foundation for Digestive Research

🇺🇸

Oklahoma City, Oklahoma, United States

Hillcrest Medical Center Endoscopy

🇺🇸

Tulsa, Oklahoma, United States

Hillcrest Medical Center

🇺🇸

Tulsa, Oklahoma, United States

Options Health Research, LLC

🇺🇸

Tulsa, Oklahoma, United States

Pittsburgh Gastroenterology Associates

🇺🇸

Pittsburgh, Pennsylvania, United States

Omega Medical Research

🇺🇸

Warwick, Rhode Island, United States

Baylor College of Medicine - Baylor Medical Center

🇺🇸

Houston, Texas, United States

Ertan Digestive Disease Center

🇺🇸

Houston, Texas, United States

One Step Diagnostic (X-Ray)

🇺🇸

Sugar Land, Texas, United States

Texas Digestive Disease Consultants

🇺🇸

Southlake, Texas, United States

Pioneer Research Solutions, Inc.

🇺🇸

SugarLand, Texas, United States

Digestive Health Specialists of Tyler

🇺🇸

Tyler, Texas, United States

Nepean Public Hospital

🇦🇺

Kingswood, New South Wales, Australia

Monash Medical Centre

🇦🇺

Clayton, Victoria, Australia

Mater Health Services

🇦🇺

South Brisbane, Queensland, Australia

Royal Brisbane and Women's Hospital

🇦🇺

Herston, Brisbane, Queensland, Australia

Eastern Health, Box Hill Hospital

🇦🇺

Box Hill, Victoria, Australia

The Royal Melbourne Hospital

🇦🇺

Parkville, Victoria, Australia

St. Vincent's Hospital Melbourne

🇦🇺

Fitzroy, Australia

CHU Saint-Pierre

🇧🇪

Bruxelles, Belgium

University Hospital Leuven

🇧🇪

Leuven, Vlaams Brabant, Belgium

Clinica do Coracao Samaritano

🇧🇷

Goiania, GO, Brazil

Center X Diagnosticos

🇧🇷

Goiania, GO, Brazil

Hospital Universitário Fraga Filho da UFRJ

🇧🇷

Rio de Janeiro, RJ, Brazil

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.

🇧🇷

Goiania, GO, Brazil

Hospital Israelita Albert Einstein

🇧🇷

São Paulo, SP, Brazil

Faculdade de Medicina do ABC

🇧🇷

Santo Andre, SP, Brazil

Klinicke centrum ISCARE I.V.F. - gastroenterologie

🇨🇿

Prague, Czech Republic

London Health Science Centre - University Hospital

🇨🇦

London, Ontario, Canada

McGill University Health Centre - Royal Victoria Hospital

🇨🇦

Montreal, Quebec, Canada

Institut klinicke a experimentalni mediciny

🇨🇿

Praha 4, Czech Republic

Fakultni nemocnice Olomouc

🇨🇿

Olomouc, Czech Republic

Fakultni nemocnice Kralovske Vinohrady

🇨🇿

Praha 10, Czech Republic

IBD Clinical and Research centre

🇨🇿

Praha 7, Czech Republic

Krajska zdravotni, a.s.

🇨🇿

Usti nad Labem, Czech Republic

Afdeling I, Gastroenterologisk Sektion

🇩🇰

Koebenhavn NV, Denmark

Hvidovre Hospital

🇩🇰

Hvidovre, Denmark

Medicinsk Afdeling, Gastroenterologisk Sektion

🇩🇰

Koege, Denmark

Hopital Saint-Antoine - Service De Gastroenterologie

🇫🇷

Paris Cedex 12, France

University General Hospital "Attikon"

🇬🇷

Athens, Greece

Praxis Dr. Howaldt

🇩🇪

Hamburg, Germany

Gastroenterologische Gemeinschaftspraxis Minden

🇩🇪

Minden, Germany

Universitaetsklinik Regensburg

🇩🇪

Regensburg, Germany

Universitaetsklinikum Schleswig-Holstein

🇩🇪

Kiel, Germany

General Hospital of Athens "Evangelismos",1st Gastroenterology Department

🇬🇷

Kolonaki Athens, Greece

Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika

🇭🇺

Budapest, Hungary

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika

🇭🇺

Szeged, Hungary

Pannonia Maganorvosi Centrum Kft.

🇭🇺

Budapest, Hungary

Clinfan Kft.

🇭🇺

Szekszard, Hungary

National Virus Reference Laboratory

🇮🇪

Dublin, Ireland

Beaumont Hospital

🇮🇪

Dublin, Ireland

Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology

🇮🇪

Dublin, Ireland

The Institute Of Gastroenterology & Liver Diseases

🇮🇱

Tel Hashomer, Ramat Gan, Israel

The E. Wolfson Medical Center

🇮🇱

Holon, Israel

University Hospital Galway

🇮🇪

Galway, Ireland

Assaf Harofeh Medical Center

🇮🇱

Zerifin, Israel

Azienda Ospedaliera - Universita di Padova

🇮🇹

Padova, Italy

Istituto Clinico Humanitas IRCCS

🇮🇹

Rozzano, Milano, Italy

A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and

🇮🇹

Rome, Province of Rome, Italy

Università Campus Biomedico

🇮🇹

Roma, Italy

Department of Gastroenterology Research

🇳🇿

Hamilton, Waikato, New Zealand

Shakespeare Specialist Group

🇳🇿

Milford, Auckland, New Zealand

Azienda Ospedaliera San Camillo Forlanini

🇮🇹

Roma, Italy

Spitalul Clinic Colentina

🇷🇴

Bucuresti, Sector 2, Romania

Christchurch Hospital

🇳🇿

Christchurch, Canterbury, New Zealand

Glenbrook Hospital Outpatient Pharmacy

🇺🇸

Glenview, Illinois, United States

NorthShore University Health System

🇺🇸

Evanston, Illinois, United States

Advanced Imaging

🇺🇸

Tulsa, Oklahoma, United States

Simon Medical Imaging

🇺🇸

Scottsdale, Arizona, United States

Metro Health Hospital

🇺🇸

Wyoming, Michigan, United States

Rocky Mountain Gastroenterology Associates

🇺🇸

Lakewood, Colorado, United States

Endoscopy Center of Connecticut, LLC

🇺🇸

Hamden, Connecticut, United States

Arapahoe Gastroenterology, PC

🇺🇸

Littleton, Colorado, United States

Central Indiana Gastroenterology Group

🇺🇸

Anderson, Indiana, United States

Gastrointestinal Specialists of Georgia, PC

🇺🇸

Marietta, Georgia, United States

Pharmacy: Wheeler and Stuckey, Inc.

🇺🇸

Oklahoma City, Oklahoma, United States

University of Kentucky

🇺🇸

Lexington, Kentucky, United States

Saint John's Research Institute

🇺🇸

Anderson, Indiana, United States

Hopital Huriez, CHRU de Lille

🇫🇷

Lille Cedex, France

Research Protocol Management Specialists

🇺🇸

Pittsburgh, Pennsylvania, United States

Pharma Resource

🇺🇸

East Providence, Rhode Island, United States

Diagnostic Clinic of Houston, PA

🇺🇸

Houston, Texas, United States

Gastro One

🇺🇸

Germantown, Tennessee, United States

Heritage Medical Research Clinic - University of Calgary

🇨🇦

Calgary, Alberta, Canada

"Charite - Campus Benjamin Franklin

🇩🇪

Berlin, Germany

Pioneer Research Solutions, Inc. (Admin. Office)

🇺🇸

Sugar Land, Texas, United States

Concord Repatriation General Hospital

🇦🇺

Concord, New South Wales, Australia

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

🇭🇺

Budapest, Hungary

Tel Aviv Sourasky Medical Center

🇮🇱

Tel Aviv, Israel

St. Vincents University Hospital

🇮🇪

Dublin 4, Ireland

Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group

🇮🇪

Dublin, Ireland

University Of Louisville Healthcare Outpatient Center

🇺🇸

Louisville, Kentucky, United States

University of Louisville Research Foundation

🇺🇸

Louisville, Kentucky, United States

University Of Louisville

🇺🇸

Louisville, Kentucky, United States

PMG Research of Winston-Salem

🇺🇸

Winston-Salem, North Carolina, United States

Professional Quality Research, Inc.

🇺🇸

Austin, Texas, United States

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

VCU Medical Investigational Drug Service (IDS)

🇺🇸

Richmond, Virginia, United States

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