B0151005 Open-Label Extension Study

NCT01345318 | Completed Phase 2 Results DMC

• 3 other identifiers: B01510052011-000722-30ANDANTE II
• Study Type: interventional
• Target: 191
• Locations: 16 countries
• Sites: 127

Brief Summary

This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; safety; efficacy; pharmacokinetics; pharmacodynamics; Crohn's Disease Activity Index (CDAI)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs

  An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.

  Baseline up to Week 48

• Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)

  Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (\>=) 4.32. Any positive ADA sample was further tested for NAbs.

  At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.

Study Arms (1)

Open-label Treatment

EXPERIMENTAL

Biological: PF-04236921

Interventions

PF-04236921 BIOLOGICAL

Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.

Open-label Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.

You may not qualify if:

• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
• Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (127)

Simon Medical Imaging

Scottsdale, Arizona, 85258, United States

Location

Digestive Health Research Unit

Scottsdale, Arizona, 85260, United States

Location

Adobe Clinical Research, LLC

Tucson, Arizona, 85712, United States

Location

Adobe Surgery Center

Tucson, Arizona, 85712, United States

Location

Rocky Mountain Gastroenterology Associates

Lakewood, Colorado, 80215, United States

Location

Rocky Mountain Gastroenterology

Littleton, Colorado, 80120, United States

Location

Rocky Mountain Clinical Research, LLC.

Wheat Ridge, Colorado, 80033, United States

Location

Rocky Mountain Clinical Research, LLC

Wheat Ridge, Colorado, 80033, United States

Location

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Gastroenterology Consultants of Clearwater

Clearwater, Florida, 33756, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Gastroenterology Associates

Crystal River, Florida, 34429, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Suncoast Endoscopy Center

Inverness, Florida, 34453, United States

Location

International Clinical Research - US, LLC

Sanford, Florida, 32771, United States

Location

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, 30033, United States

Location

The Atlanta Center For Gastroenterology

Decatur, Georgia, 30033, United States

Location

Gastointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Illinois Gastroenterology Group, LLC

Arlington Heights, Illinois, 60005, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

U of L Health Care Outpatient Center

Louisville, Kentucky, 40202, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Digestive Disorders Associates

Annapolis, Maryland, 21401, United States

Location

Drgestive Disorders Associates

Annapolis, Maryland, 21401, United States

Location

East Valley Endoscopy

Grand Rapids, Michigan, 49546, United States

Location

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

Metro Health Hospital Endoscopy Unit

Wyoming, Michigan, 49519, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Huron Gastroenterology Associates

Ypsilanti, Michigan, 48197, United States

Location

Weill Cornell Medical College of Cornell University

New York, New York, 10021, United States

Location

Present, Chapman, Steinlauf and Marion

New York, New York, 10028, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

New York, New York, 10065, United States

Location

Weill Cornell Imaging at New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Weill Cornell Medical College of Cornell University-Greenberg

New York, New York, 10065, United States

Location

Arthur Asher Kombluth, MD PC

New York, New York, 10128, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73102, United States

Location

Pharmacy: Wheeler and Stuckey, Inc.

Oklahoma City, Oklahoma, 73103, United States

Location

Colonoscopy and X-rays: OU Physicians Building

Oklahoma City, Oklahoma, 73104, United States

Location

Hillcrest Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Pittsburgh Gastroenterology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Research Protocol Management Specialists

Pittsburgh, Pennsylvania, 15243, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center: IBD Clinic

Nashville, Tennessee, 37212-1375, United States

Location

Vanderbilt University Medical Center-GI Research

Nashville, Tennessee, 37212-1610, United States

Location

IBD Center-Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University Medical Center-IDS

Nashville, Tennessee, 37212, United States

Location

Professional Quality Research, Inc.

Austin, Texas, 78705, United States

Location

Austin Gastroenterology, PA

Austin, Texas, 78745, United States

Location

Diagnostic Clinic Of Houston Pa

Houston, Texas, 77004, United States

Location

Diagnostic Clinic of Houston, PA

Houston, Texas, 77004, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The University of TX Health Sci. Ctr at Houston

Houston, Texas, 77030, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Clinical Pathologiy Laboratories, Inc, DBA DRL Labs

Tyler, Texas, 75701, United States

Location

Digestive Health Specialists of Tyler

Tyler, Texas, 75701, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

VC Medical Center Investigative Drug Service (IDS) [Ship Drug To]

Richmond, Virginia, 23298, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Mater Health Services

South Brisbane, Queensland, 4101, Australia

Location

Eastern Health, Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

Chu St Pierre

Brussels, 1000, Belgium

Location

University Hospital Leuven, Campus Gasthuisberg

Leuven, 3000, Belgium

Location

H.-Hartziekenhuis Roeselare-Menen vzw

Roeselare, 8800, Belgium

Location

Hospital Nossa Senhora das Gracas

Curitiba, Paraná, 80810-040, Brazil

Location

Setor de Cardiologia do Hospital Nossa Senhora das Gracas

Curitiba, Paraná, 80810-040, Brazil

Location

Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas

Curitiba, Paraná, 80810-040, Brazil

Location

Hospital Universitário Fraga Filho da UFRJ

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Laboratório de Análises Clínicas do HUCFF/UFRJ

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05651-901, Brazil

Location

Heritage Medical Research Clinic - University of Calgary

Calgary, Alberta, T2N4Z6, Canada

Location

London Health Science Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Montreal General Hospital - McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Hepato-Gastroenterologie HK, s.r.o. Poliklinika III

Hradec Králové, 500 12, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Fakultni Nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Institut klinicke a experimentalni mediciny

Prague, 140 21, Czechia

Location

Krajska zdravotni, a.s.

Ústí nad Labem, 40113, Czechia

Location

Aarhus Universitetshospital, Aarhus Sygehus

Aarhus C, 8000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

"Gastroenheden Herlev Hospital

Herlev, 2730, Denmark

Location

"Kirurgisk Afdeling 0143 Hilleroed Hospital

Hilleroed, 3400, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Bispebjerg Hospital

Koebenhavn NV, 2400, Denmark

Location

Medicinsk Afdeling, Gastroenterologisk Sektion

Koege, 4600, Denmark

Location

Hopital Saint-Antoine - Service De Gastroenterologie

Paris, Cedex 12, 75571, France

Location

Hopital Huriez CHRU de Lille

Lille, 59037, France

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Praxis Dr. Howaldt

Hamburg, 20148, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Gastroenterologische Gemeinschaftspraxis Minden

Minden, 32423, Germany

Location

Pannonia Maganorvosi Centrum Kft.

Budapest, 1136, Hungary

Location

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

Debrecen, 4032, Hungary

Location

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

Szeged, 6720, Hungary

Location

Clinfan Kft.

Szekszárd, 7100, Hungary

Location

National Virus Reference Laboratory

Dublin, D04 FX62, Ireland

Location

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

Dublin, D04 T6F4, Ireland

Location

Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology

Dublin, D07 K201, Ireland

Location

St. Vincents University Hospital

Dublin, DUBLIN 4, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Digestive Disease Institute

Beith Vagan, Jerusalem, 91031, Israel

Location

Institute of Gastroenterology

Haifa, 3339419, Israel

Location

Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO)

Jerusalem, 91120, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Istituto Clinico Humanitas IRCCS

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliera - Universita di Padova

Padua, 35128, Italy

Location

Universita Campus Biomedico UOC di Gastroenterologia

Roma, 00128, Italy

Location

AOS San Camillo Forlanini

Rome, 00152, Italy

Location

Shakespeare Specialist Group

Milford, Auckland, 0620, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

Universitaetsspital Zuerich

Zurich, 8091, Switzerland

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, G4 0SS, United Kingdom

Location

Barts Health NHS Trust-Royal London Hospital

London, E1 1BB, United Kingdom

Location

Clinical Research Centre

London, E1 2AT, United Kingdom

Location

St Bartholomew's Hospital (Barts Health NHS Trust)

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

• Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.

  PMID: 29247068 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Crohn Disease

Interventions

PF-04236921

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 2, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 12, 2024
• Results First Posted: March 20, 2017

Record last verified: 2017-01

Locations

DK (7); DE (4); NZ (2); GB (5); US (62); FR (2); BE (4); IL (6); BR (6); IE (5); AU (6); CH (1); CA (4); CZ (5); IT (4); HU (4)