B0151005 Open-Label Extension Study

Crohn's Disease Clinical Trial

— ANDANTE II  

Official title:

A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345318
• Other study ID #: B0151005
• Secondary ID: 2011-000722-30AN
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: March 2016

Study information

• Verified date: January 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
• 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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• PF-04236921
Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.
• PF-04236921
Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.

Locations

Country	Name	City	State
Australia	Eastern Health, Box Hill Hospital	Box Hill	Victoria
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Australia	Mater Health Services	South Brisbane	Queensland
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	Chu St Pierre	Bruxelles
Belgium	University Hospital Leuven, Campus Gasthuisberg	Leuven
Belgium	H.-Hartziekenhuis Roeselare-Menen vzw	Roeselare
Brazil	Hospital Nossa Senhora das Gracas	Curitiba	PR
Brazil	Setor de Cardiologia do Hospital Nossa Senhora das Gracas	Curitiba	PR
Brazil	Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas	Curitiba	PR
Brazil	Hospital Universitário Fraga Filho da UFRJ	Rio de Janeiro	RJ
Brazil	Laboratório de Análises Clínicas do HUCFF/UFRJ	Rio de Janeiro	RJ
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP
Canada	Heritage Medical Research Clinic - University of Calgary	Calgary	Alberta
Canada	London Health Science Centre - University Hospital	London	Ontario
Canada	Montreal General Hospital - McGill University Health Centre	Montreal	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Czechia	Hepato-Gastroenterologie HK, s.r.o. Poliklinika III	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni Nemocnice Kralovske Vinohrady	Praha 10
Czechia	Institut klinicke a experimentalni mediciny	Praha 4
Czechia	Krajska zdravotni, a.s.	Usti nad Labem
Denmark	Aarhus Universitetshospital, Aarhus Sygehus	Aarhus C
Denmark	"Gastroenheden Herlev Hospital	Herlev
Denmark	"Kirurgisk Afdeling 0143 Hilleroed Hospital	Hilleroed
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Rigshospitalet	Koebenhavn
Denmark	Bispebjerg Hospital	Koebenhavn NV
Denmark	Medicinsk Afdeling, Gastroenterologisk Sektion	Koege
France	Hopital Huriez CHRU de Lille	Lille Cedex
France	Hopital Saint-Antoine - Service De Gastroenterologie	Paris	Cedex 12
Germany	Praxis Dr. Howaldt	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Hungary	Pannonia Maganorvosi Centrum Kft.	Budapest
Hungary	Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum	Debrecen
Hungary	Szegedi Tudomanyegyetem altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika	Szeged
Hungary	Clinfan Kft.	Szekszard
Ireland	Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology	Dublin
Ireland	National Virus Reference Laboratory	Dublin
Ireland	Pathology, Haematology and Biochemistry Laboratories, St. Vincent's Healthcare Group	Dublin
Ireland	St. Vincents University Hospital	Dublin
Ireland	University Hospital Galway	Galway
Israel	Digestive Disease Institute	Beith Vagan	Jerusalem
Israel	Institute of Gastroenterology	Haifa
Israel	Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO)	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center, Beilinson Hospital	Petah Tikva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera - Universita di Padova	Padova
Italy	Universita Campus Biomedico UOC di Gastroenterologia	Roma
Italy	AOS San Camillo Forlanini	Rome
Italy	Istituto Clinico Humanitas IRCCS	Rozzano	Milano
New Zealand	Waikato Hospital	Hamilton
New Zealand	Shakespeare Specialist Group	Milford	Auckland
Switzerland	Universitaetsspital Zuerich	Zuerich
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Barts Health NHS Trust-Royal London Hospital	London
United Kingdom	Clinical Research Centre	London
United Kingdom	St Bartholomew's Hospital (Barts Health NHS Trust)	London
United States	Digestive Disorders Associates	Annapolis	Maryland
United States	Drgestive Disorders Associates	Annapolis	Maryland
United States	Illinois Gastroenterology Group, LLC	Arlington Heights	Illinois
United States	Austin Gastroenterology, PA	Austin	Texas
United States	Professional Quality Research, Inc.	Austin	Texas
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Gastroenterology Consultants of Clearwater	Clearwater	Florida
United States	Gastroenterology Associates	Crystal River	Florida
United States	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia
United States	The Atlanta Center For Gastroenterology	Decatur	Georgia
United States	NorthShore University Health System	Evanston	Illinois
United States	Gastro One	Germantown	Tennessee
United States	East Valley Endoscopy	Grand Rapids	Michigan
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Diagnostic Clinic Of Houston Pa	Houston	Texas
United States	Diagnostic Clinic of Houston, PA	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	The University of TX Health Sci. Ctr at Houston	Houston	Texas
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Suncoast Endoscopy Center	Inverness	Florida
United States	Rocky Mountain Gastroenterology Associates	Lakewood	Colorado
United States	University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Rocky Mountain Gastroenterology	Littleton	Colorado
United States	U of L Health Care Outpatient Center	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Gastointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	IBD Center-Vanderbilt University Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center-GI Research	Nashville	Tennessee
United States	Vanderbilt University Medical Center-IDS	Nashville	Tennessee
United States	Vanderbilt University Medical Center: IBD Clinic	Nashville	Tennessee
United States	Arthur Asher Kombluth, MD PC	New York	New York
United States	Mount Sinai School of Medicine	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	Weill Cornell Imaging at New York Presbyterian Hospital	New York	New York
United States	Weill Cornell Medical College of Cornell University	New York	New York
United States	Weill Cornell Medical College of Cornell University-Greenberg	New York	New York
United States	Colonoscopy and X-rays: OU Physicians Building	Oklahoma City	Oklahoma
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma
United States	Pharmacy: Wheeler and Stuckey, Inc.	Oklahoma City	Oklahoma
United States	Pittsburgh Gastroenterology Associates	Pittsburgh	Pennsylvania
United States	Research Protocol Management Specialists	Pittsburgh	Pennsylvania
United States	VC Medical Center Investigative Drug Service (IDS) [Ship Drug To]	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Utah Hospital	Salt Lake City	Utah
United States	International Clinical Research - US, LLC	Sanford	Florida
United States	Digestive Health Research Unit	Scottsdale	Arizona
United States	Simon Medical Imaging	Scottsdale	Arizona
United States	Texas Digestive Disease Consultants	Southlake	Texas
United States	Adobe Clinical Research, LLC	Tucson	Arizona
United States	Adobe Surgery Center	Tucson	Arizona
United States	Hillcrest Medical Center	Tulsa	Oklahoma
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Clinical Pathologiy Laboratories, Inc, DBA DRL Labs	Tyler	Texas
United States	Digestive Health Specialists of Tyler	Tyler	Texas
United States	Rocky Mountain Clinical Research, LLC	Wheat Ridge	Colorado
United States	Rocky Mountain Clinical Research, LLC.	Wheat Ridge	Colorado
United States	Gastroenterology Associates of Western Michigan	Wyoming	Michigan
United States	Metro Health Hospital	Wyoming	Michigan
United States	Metro Health Hospital Endoscopy Unit	Wyoming	Michigan
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  New Zealand,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.

External Links

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