AzTrials
AzTrials

Crohn's DiseasePhase 2ANDANTE IINCT01345318

B0151005 Open-Label Extension Study

A Phase 2 study testing PF-04236921 in people with Crohn's Disease, run by Pfizer at 127 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
PF-04236921
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
127 sitesin 16 countries
Study dates
Jun 2011to Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

127 sites in 16 countries.

127 sites in 16 countries

United States62 sites

  • Digestive Disorders Associates

    Annapolis, Maryland, 21401

  • Drgestive Disorders Associates

    Annapolis, Maryland, 21401

  • Illinois Gastroenterology Group, LLC

    Arlington Heights, Illinois, 60005

  • Professional Quality Research, Inc.

    Austin, Texas, 78705

  • Austin Gastroenterology, PA

    Austin, Texas, 78745

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Gastroenterology Consultants of Clearwater

    Clearwater, Florida, 33756

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Gastroenterology Associates

    Crystal River, Florida, 34429

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • The Atlanta Center For Gastroenterology

    Decatur, Georgia, 30033

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Gastro One

    Germantown, Tennessee, 38138

  • East Valley Endoscopy

    Grand Rapids, Michigan, 49546

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Diagnostic Clinic Of Houston Pa

    Houston, Texas, 77004

  • Diagnostic Clinic of Houston, PA

    Houston, Texas, 77004

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • The University of TX Health Sci. Ctr at Houston

    Houston, Texas, 77030

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Suncoast Endoscopy Center

    Inverness, Florida, 34453

  • Rocky Mountain Gastroenterology Associates

    Lakewood, Colorado, 80215

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • Rocky Mountain Gastroenterology

    Littleton, Colorado, 80120

  • U of L Health Care Outpatient Center

    Louisville, Kentucky, 40202

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • Gastointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Vanderbilt University Medical Center: IBD Clinic

    Nashville, Tennessee, 37212-1375

  • Vanderbilt University Medical Center-GI Research

    Nashville, Tennessee, 37212-1610

  • IBD Center-Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Vanderbilt University Medical Center-IDS

    Nashville, Tennessee, 37212

  • Weill Cornell Medical College of Cornell University

    New York, New York, 10021

  • Present, Chapman, Steinlauf and Marion

    New York, New York, 10028

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

    New York, New York, 10065

  • Weill Cornell Imaging at New York Presbyterian Hospital

    New York, New York, 10065

  • Weill Cornell Medical College of Cornell University-Greenberg

    New York, New York, 10065

  • Arthur Asher Kombluth, MD PC

    New York, New York, 10128

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma, 73102

  • Pharmacy: Wheeler and Stuckey, Inc.

    Oklahoma City, Oklahoma, 73103

  • Colonoscopy and X-rays: OU Physicians Building

    Oklahoma City, Oklahoma, 73104

  • Pittsburgh Gastroenterology Associates

    Pittsburgh, Pennsylvania, 15241

  • Research Protocol Management Specialists

    Pittsburgh, Pennsylvania, 15243

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

    Richmond, Virginia, 23298

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • International Clinical Research - US, LLC

    Sanford, Florida, 32771

  • Simon Medical Imaging

    Scottsdale, Arizona, 85258

  • Digestive Health Research Unit

    Scottsdale, Arizona, 85260

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712

  • Adobe Surgery Center

    Tucson, Arizona, 85712

  • Hillcrest Medical Center

    Tulsa, Oklahoma, 74104

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Clinical Pathologiy Laboratories, Inc, DBA DRL Labs

    Tyler, Texas, 75701

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Rocky Mountain Clinical Research, LLC.

    Wheat Ridge, Colorado, 80033

  • Rocky Mountain Clinical Research, LLC

    Wheat Ridge, Colorado, 80033

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

  • Metro Health Hospital Endoscopy Unit

    Wyoming, Michigan, 49519

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

Other trials in United States

Denmark7 sites

  • Aarhus Universitetshospital, Aarhus Sygehus

    Aarhus C, 8000

  • Rigshospitalet

    Copenhagen, 2100

  • "Gastroenheden Herlev Hospital

    Herlev, 2730

  • "Kirurgisk Afdeling 0143 Hilleroed Hospital

    Hilleroed, 3400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Bispebjerg Hospital

    Koebenhavn NV, 2400

  • Medicinsk Afdeling, Gastroenterologisk Sektion

    Koege, 4600

Other trials in Denmark

Australia6 sites

  • Eastern Health, Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Mater Health Services

    South Brisbane, Queensland, 4101

Other trials in Australia

Brazil6 sites

  • Hospital Nossa Senhora das Gracas

    Curitiba, Paraná, 80810-040

  • Setor de Cardiologia do Hospital Nossa Senhora das Gracas

    Curitiba, Paraná, 80810-040

  • Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas

    Curitiba, Paraná, 80810-040

  • Hospital Universitário Fraga Filho da UFRJ

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • Laboratório de Análises Clínicas do HUCFF/UFRJ

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05651-901

Other trials in Brazil

Israel6 sites

  • Digestive Disease Institute

    Beith Vagan, Jerusalem, 91031

  • Institute of Gastroenterology

    Haifa, 3339419

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

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Czechia5 sites

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

    Hradec Králové, 500 12

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Institut klinicke a experimentalni mediciny

    Prague, 140 21

  • Krajska zdravotni, a.s.

    Ústí nad Labem, 40113

Other trials in Czechia

Ireland5 sites

  • National Virus Reference Laboratory

    Dublin, D04 FX62

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

    Dublin, D04 T6F4

  • Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology

    Dublin, D07 K201

  • St. Vincents University Hospital

    Dublin, DUBLIN 4

  • University Hospital Galway

    Galway

Other trials in Ireland

United Kingdom5 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Glasgow Royal Infirmary

    Glasgow, G4 0SS

  • Barts Health NHS Trust-Royal London Hospital

    London, E1 1BB

  • Clinical Research Centre

    London, E1 2AT

  • St Bartholomew's Hospital (Barts Health NHS Trust)

    London, EC1A 7BE

Other trials in United Kingdom

Belgium4 sites

  • CHU Saint-Pierre

    Brussels, 1000

  • Chu St Pierre

    Brussels, 1000

  • University Hospital Leuven, Campus Gasthuisberg

    Leuven, 3000

  • H.-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

Canada4 sites

  • Heritage Medical Research Clinic - University of Calgary

    Calgary, Alberta, T2N4Z6

  • London Health Science Centre - University Hospital

    London, Ontario, N6A 5A5

  • Montreal General Hospital - McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

Germany4 sites

  • Praxis Dr. Howaldt

    Hamburg, 20148

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

Other trials in Germany

Hungary4 sites

  • Pannonia Maganorvosi Centrum Kft.

    Budapest, 1136

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

    Debrecen, 4032

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

    Szeged, 6720

  • Clinfan Kft.

    Szekszárd, 7100

Other trials in Hungary

Italy4 sites

  • Azienda Ospedaliera - Universita di Padova

    Padova, 35128

  • Universita Campus Biomedico UOC di Gastroenterologia

    Roma, 00128

  • AOS San Camillo Forlanini

    Rome, 00152

  • Istituto Clinico Humanitas IRCCS

    Rozzano, Milano, 20089

Other trials in Italy

France2 sites

  • Hopital Huriez CHRU de Lille

    Lille, 59037

  • Hopital Saint-Antoine - Service De Gastroenterologie

    Paris, Cedex 12, 75571

Other trials in France

New Zealand2 sites

  • Waikato Hospital

    Hamilton, 3204

  • Shakespeare Specialist Group

    Milford, Auckland, 0620

Other trials in New Zealand

Switzerland1 site

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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
Being tested
PF-04236921
Keywords
Crohn's Disease, safety, efficacy, pharmacokinetics, pharmacodynamics, Crohn's Disease Activity Index (CDAI)
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-04236921Biological

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

  • PF-04236921Biological

    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.

Study groups in NCT01345318
Study groupRoleWhat they receive
Open-label TreatmentExperimentalNot described
Receives: Biological: PF-04236921

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to Week 48

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01345318
Sponsor's protocol ID
B0151005
Other IDs
2011-000722-30, ANDANTE II
Acronym
ANDANTE II
Status last verified
Jan 2017
First submitted
28 Apr 2011
Last updated
12 Jan 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29247068

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04236921 in people with Crohn's Disease, run by Pfizer at 127 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Denmark, Australia, Brazil, Israel and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs (time frame: Baseline up to Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01345318, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in