Clinical trial NCT01345318: B0151005 Open-Label Extension Study
Official title: A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
safety
efficacy
pharmacokinetics
pharmacodynamics
Crohn's Disease Activity Index (CDAI)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
timeFrame: Baseline up to Week 48
measure: Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
timeFrame: At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Simon Medical Imaging
state: Arizona
city: Scottsdale
country: United States
facility: Digestive Health Research Unit
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Adobe Surgery Center
state: Arizona
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Clinical Research, LLC.
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Clinical Research, LLC
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Gastroenterology Consultants of Clearwater
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Crystal River
country: United States
facility: Gastroenterology Associates
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Inverness
country: United States
facility: Suncoast Endoscopy Center
state: Florida
city: Sanford
country: United States
facility: International Clinical Research - US, LLC
state: Florida
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Decatur
country: United States
facility: The Atlanta Center For Gastroenterology
state: Georgia
city: Marietta
country: United States
facility: Gastointestinal Specialists of Georgia, PC
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Gastroenterology Group, LLC
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: U of L Health Care Outpatient Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Annapolis
country: United States
facility: Digestive Disorders Associates
state: Maryland
city: Annapolis
country: United States
facility: Drgestive Disorders Associates
state: Maryland
city: Grand Rapids
country: United States
facility: East Valley Endoscopy
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital Endoscopy Unit
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: New York
country: United States
facility: Weill Cornell Medical College of Cornell University
state: New York
city: New York
country: United States
facility: Present, Chapman, Steinlauf and Marion
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy
state: New York
city: New York
country: United States
facility: Weill Cornell Imaging at New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College of Cornell University-Greenberg
state: New York
city: New York
country: United States
facility: Arthur Asher Kombluth, MD PC
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pharmacy: Wheeler and Stuckey, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: Colonoscopy and X-rays: OU Physicians Building
state: Oklahoma
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Pittsburgh
country: United States
facility: Pittsburgh Gastroenterology Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center: IBD Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center-GI Research
state: Tennessee
city: Nashville
country: United States
facility: IBD Center-Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center-IDS
state: Tennessee
city: Austin
country: United States
facility: Professional Quality Research, Inc.
state: Texas
city: Austin
country: United States
facility: Austin Gastroenterology, PA
state: Texas
city: Houston
country: United States
facility: Diagnostic Clinic Of Houston Pa
state: Texas
city: Houston
country: United States
facility: Diagnostic Clinic of Houston, PA
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: The University of TX Health Sci. Ctr at Houston
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Tyler
country: United States
facility: Clinical Pathologiy Laboratories, Inc, DBA DRL Labs
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Richmond
country: United States
facility: VC Medical Center Investigative Drug Service (IDS) [Ship Drug To]
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Health Services
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Health, Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Bruxelles
country: Belgium
facility: Chu St Pierre
city: Leuven
country: Belgium
facility: University Hospital Leuven, Campus Gasthuisberg
city: Roeselare
country: Belgium
facility: H.-Hartziekenhuis Roeselare-Menen vzw
city: Curitiba
country: Brazil
facility: Hospital Nossa Senhora das Gracas
state: PR
city: Curitiba
country: Brazil
facility: Setor de Cardiologia do Hospital Nossa Senhora das Gracas
state: PR
city: Curitiba
country: Brazil
facility: Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas
state: PR
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Fraga Filho da UFRJ
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Laboratório de Análises Clínicas do HUCFF/UFRJ
state: RJ
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic - University of Calgary
state: Alberta
city: London
country: Canada
facility: London Health Science Centre - University Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital - McGill University Health Centre
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o. Poliklinika III
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
city: Praha 4
country: Czechia
facility: Institut klinicke a experimentalni mediciny
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s.
city: Aarhus C
country: Denmark
facility: Aarhus Universitetshospital, Aarhus Sygehus
city: Herlev
country: Denmark
facility: "Gastroenheden Herlev Hospital
city: Hilleroed
country: Denmark
facility: "Kirurgisk Afdeling 0143 Hilleroed Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Koebenhavn NV
country: Denmark
facility: Bispebjerg Hospital
city: Koebenhavn
country: Denmark
facility: Rigshospitalet
city: Koege
country: Denmark
facility: Medicinsk Afdeling, Gastroenterologisk Sektion
city: Paris
country: France
facility: Hopital Saint-Antoine - Service De Gastroenterologie
state: Cedex 12
city: Lille Cedex
country: France
facility: Hopital Huriez CHRU de Lille
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Hamburg
country: Germany
facility: Praxis Dr. Howaldt
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika
city: Szekszard
country: Hungary
facility: Clinfan Kft.
city: Dublin
country: Ireland
facility: National Virus Reference Laboratory
city: Dublin
country: Ireland
facility: Pathology, Haematology and Biochemistry Laboratories, St. Vincent's Healthcare Group
city: Dublin
country: Ireland
facility: Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology
city: Dublin
country: Ireland
facility: St. Vincents University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Beith Vagan
country: Israel
facility: Digestive Disease Institute
state: Jerusalem
city: Haifa
country: Israel
facility: Institute of Gastroenterology
city: Jerusalem
country: Israel
facility: Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO)
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas IRCCS
state: Milano
city: Padova
country: Italy
facility: Azienda Ospedaliera - Universita di Padova
city: Roma
country: Italy
facility: Universita Campus Biomedico UOC di Gastroenterologia
city: Rome
country: Italy
facility: AOS San Camillo Forlanini
city: Milford
country: New Zealand
facility: Shakespeare Specialist Group
state: Auckland
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: London
country: United Kingdom
facility: Barts Health NHS Trust-Royal London Hospital
city: London
country: United Kingdom
facility: Clinical Research Centre
city: London
country: United Kingdom
facility: St Bartholomew's Hospital (Barts Health NHS Trust)
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.