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Crohn's DiseasePhase 2ANDANTENCT01287897

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

A Phase 2 study testing PF-04236921 SC injection in people with Crohn's Disease, run by Pfizer at 193 sites in 18 countries.

Completed

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

Official record
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Trial 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. 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 SC injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
193 sitesin 18 countries
Study dates
Feb 2011to Feb 2015
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 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

Who cannot join

  • 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

Trial locations and contacts

193 sites in 18 countries.

193 sites in 18 countries

United States98 sites

  • Central Indiana Gastroenterology Group

    Anderson, Indiana, 46016

  • Saint John's Research Institute

    Anderson, Indiana, 46016

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Digestive Disorders Associates

    Annapolis, Maryland, 21401

  • Disgestive Disorders Associates

    Annapolis, Maryland, 21401

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • Maryland Diagnostics & Therapeutic Endo Center

    Annapolis, Maryland, 21401

  • Illinois Gastroenterology Group, LLC

    Arlington Heights, Illinois, 60005

  • Professional Quality Research, Inc.

    Austin, Texas, 78705

  • UAB Hospital

    Birmingham, Alabama, 35249

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Commonwealth Clinical Studies

    Brockton, Massachusetts, 02302

  • The University of Chicago Medical Center (Ucmc)

    Chicago, Illinois, 60637

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The University of Chicago Medical

    Chicago, Illinois, 60637

  • The University Of Chicago

    Chicago, Illinois, 60637

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Gastroenterology Associates

    Crystal River, Florida, 34429

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • Atlanta Endoscopy Center

    Decatur, Georgia, 30033

  • Decatur Health Imaging

    Decatur, Georgia, 30033

  • Rocky Mountain Clinical Research, LLC

    Denver, Colorado, 80222

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Prima CARE, PC

    Fall River, Massachusetts, 02721

  • Gastro One

    Germantown, Tennessee, 38138

  • Glenbrook Hospital Outpatient Pharmacy

    Glenview, Illinois, 60025

  • Glenbrook Hospital

    Glenview, Illinois, 60026

  • East Valley Endoscopy

    Grand Rapids, Michigan, 49546

  • Endoscopy Center of Connecticut, LLC

    Guilford, Connecticut, 06437

  • Endoscopy Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Gastroenterology Center of Connecticut, PC

    Hamden, Connecticut, 06518

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Diagnostic Clinic of Houston, PA

    Houston, Texas, 77004

  • Houston Hospital for Specialized Surgery (Endoscopy Only)

    Houston, Texas, 77004

  • Baylor Clinic (Drug Storage)

    Houston, Texas, 77030

  • Baylor College of Medicine - Baylor Medical Center

    Houston, Texas, 77030

  • Ertan Digestive Disease Center

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • The University of Texas Medical School at Houston

    Houston, Texas, 77030

  • Physicians Endoscopy Center (Colonoscopy)

    Houston, Texas, 77036

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • Suncoast Endoscopy Center

    Inverness, Florida, 34453

  • Rocky Mountain Gastroenterology Associates

    Lakewood, Colorado, 80215

  • Rocky Mountain Gastroenterology

    Lakewood, Colorado, 80215

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Arapahoe Gastroenterology, PC

    Littleton, Colorado, 80120

  • University Of Louisville Healthcare Outpatient Center

    Louisville, Kentucky, 40202

  • University of Louisville Research Foundation

    Louisville, Kentucky, 40202

  • University Of Louisville

    Louisville, Kentucky, 40202

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • GI Diagnostics

    Marietta, Georgia, 30067

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • Weill Cornell Medical College of Cornell University-Greenberg

    New York, New York, 10021

  • 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

  • New York Presbyterian Hospital

    New York, New York, 10065

  • Weill Cornell Imaging at New York Presbyterian Hospital

    New York, New York, 10065

  • Arthur asher Kornbluth, 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, 15243

  • Research Protocol Management Specialists

    Pittsburgh, Pennsylvania, 15243

  • Minnesota Gastroenterology, PA

    Plymouth, Minnesota, 55446

  • Virginia Commonwealth University

    Richmond, Virginia, 23298-0341

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • VCU Medical Investigational Drug Service (IDS)

    Richmond, Virginia, 93298-5028

  • University Of Utah HSC

    Salt Lake City, Utah, 84132

  • UCSF Endoscopy Unit at Mount Zion

    San Francisco, California, 94115

  • University of California - San Francisco

    San Francisco, California, 94115

  • University of California San Francisco at Mount Zion

    San Francisco, California, 94115

  • 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

  • One Step Diagnostic (X-Ray)

    Sugar Land, Texas, 77478

  • Pioneer Research Solutions, Inc. (Admin. Office)

    Sugar Land, Texas, 77479

  • Pioneer Research Solutions, Inc.

    SugarLand, Texas, 77479

  • Adobe Clinical Research, Llc

    Tucson, Arizona, 85712

  • Radiology Ltd

    Tucson, Arizona, 85712

  • Hillcrest Medical Center Endoscopy

    Tulsa, Oklahoma, 74104

  • Hillcrest Medical Center

    Tulsa, Oklahoma, 74104

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Utica Park Clinic X-Ray

    Tulsa, Oklahoma, 74104

  • Advanced Imaging

    Tulsa, Oklahoma, 74137-4200

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • 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

  • St. Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

Israel9 sites

  • Institute of Gastroenterology

    Haifa, 3339419

  • The E. Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center

    Jerusalem, 91120

  • Dept of Gastroenterology & Hepatology

    Kfar Saba, 44281

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • The Institute Of Gastroenterology & Liver Diseases

    Tel HaShomer, Ramat Gan, 52621

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

United Kingdom9 sites

  • Addenbrooke's Hospital, Department of Gastroenterology

    Cambridge, CB2 0QQ

  • Glasgow Royal Infirmary

    Glasgow, G40SS

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, East Yorkshire, HU3 2JZ

  • Pharmacy Department

    Hull, HU3 2JZ

  • Barts and The London NHS Trust

    London, E1 1BB

  • Royal Free Hospital (Royal Free London NHS Foundation Trust)

    London, NW3 2QG

  • Royal Victoria Hospital

    Newcastle upon Tyne, NE1 4LP

  • New Cross Hospital

    Wolverhampton, WV10 0QP

  • Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust

    Wolverhampton, WV69AT

Other trials in United Kingdom

Australia8 sites

  • Eastern Health, Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St. Vincent's Hospital Melbourne

    Fitzroy, VIC 3065

  • Royal Brisbane and Women's Hospital

    Herston, Brisbane, Queensland, 4029

  • Nepean Public Hospital

    Kingswood, New South Wales, 2747

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mater Health Services

    South Brisbane, Queensland, 4101

Other trials in Australia

Brazil8 sites

  • Hospital Nossa Senhora das Gracas

    Curitiba, 80810-040

  • Clinica do Coracao Samaritano

    Goiânia, Goiás, 74535-170

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.

    Goiânia, Goiás, 74535-170

  • Center X Diagnosticos

    Goiânia, Goiás, 74535-900

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Universitário Fraga Filho da UFRJ

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05651-901

Other trials in Brazil

Czechia8 sites

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

    Hradec Králové, 500 12

  • Medial Pharma s.r.o.,

    Hradec Králové, 500 12

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Klinicke centrum ISCARE I.V.F. - gastroenterologie

    Prague, Prague, 170 04

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Institut klinicke a experimentalni mediciny

    Prague, 14021

  • IBD Clinical and Research centre

    Prague

  • Krajska zdravotni, a.s.

    Ústí nad Labem, 40113

Other trials in Czechia

Denmark8 sites

  • Aalborg Sygehus

    Aalborg, 9100

  • Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital

    Aarhus C, 8000

  • Rigshospitalet

    Copenhagen, 2100

  • Gastroenheden

    Herlev, 2730

  • Kirurgisk Afdeling 0143

    Hilleroed, 3400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Afdeling I, Gastroenterologisk Sektion

    Koebenhavn NV, 2400

  • Medicinsk Afdeling, Gastroenterologisk Sektion

    Koege, 4600

Other trials in Denmark

Italy8 sites

  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera - Universita di Padova

    Padova, Padova, 35128

  • Università Campus Biomedico

    Roma, 00128

  • Policlinico Tor Vergata

    Roma, 00133

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00151

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

    Rome, Province of Rome, 00168

  • Istituto Clinico Humanitas IRCCS

    Rozzano, Milano, 20089

  • Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva

    San Giovanni Rotondo Fg, Foggia, 71013

Other trials in Italy

Germany6 sites

  • "Charite - Campus Benjamin Franklin

    Berlin, 12200

  • Praxis Dr. Howaldt

    Hamburg, 20148

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Universitaetsklinik Regensburg

    Regensburg, 93053

Other trials in Germany

Hungary6 sites

  • Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika

    Budapest, 1088

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

    Budapest, 1125

  • 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

Ireland6 sites

  • Beaumont Hospital

    Dublin, 9

  • National Virus Reference Laboratory

    Dublin, Dublin 4

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

    Dublin, Dublin 4

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

    Dublin, Dublin 7

  • St. Vincents University Hospital

    Dublin

  • University Hospital Galway

    Galway

Other trials in Ireland

Belgium4 sites

  • CHU Saint-Pierre

    Brussels, 1000

  • University Hospital Leuven

    Leuven, Vlaams Brabant, 3000

  • UZ Leuven Pharmacy

    Leuven, 3000

  • An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, B-8800

Other trials in Belgium

Canada4 sites

  • Heritage Medical Research Clinic - University of Calgary

    Calgary, Alberta, T2N 4Z6

  • London Health Science Centre - University Hospital

    London, Ontario, N6A 5A5

  • McGill University Health Centre - Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

Other trials in Canada

New Zealand4 sites

  • Christchurch Hospital

    Christchurch, Canterbury, 8011

  • Department of Gastroenterology Research

    Hamilton, Waikato Region, 3204

  • Shakespeare Specialist Group

    Milford, Auckland, 0620

  • P3 Research Limited

    Wellington, 6021

Other trials in New Zealand

France3 sites

  • Hopital Huriez, CHRU de Lille

    Lille, 59037

  • Hopital Saint-Antoine - Service De Gastroenterologie

    Paris, 75571

  • Hopital de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Greece2 sites

  • University General Hospital "Attikon"

    Athens, 12462

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

    Kolonaki Athens, 106 76

Other trials in Greece

Romania1 site

  • Spitalul Clinic Colentina

    Bucharest, Sector 2, 020125

Other trials in Romania

Switzerland1 site

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)

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.

Conditions
Crohn's Disease
Being tested
PF-04236921 SC injection
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-04236921 SC injectionDrug

    Placebo delivered SC, 2 doses separated by 4 weeks

  • PF-04236921 SC injectionDrug

    Drug dose level 1 delivered SC, 2 doses separated by 4 weeks

  • PF-04236921 SC injectionDrug

    Drug dose level 2 delivered SC, 2 doses separated by 4 weeks

Study groups in NCT01287897
Study groupRoleWhat they receive
Placebo- SC injectionPlacebo comparatorNot described
Receives: Drug: PF-04236921 SC injection
Drug Dose level 1 - SC injectionExperimentalNot described
Receives: Drug: PF-04236921 SC injection
Drug Dose level 2 - SC injectionExperimentalNot described
Receives: Drug: PF-04236921 SC injection

What is being measured

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

  1. 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 mg

    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).

    Measured: Baseline and Week 8

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

    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.

    Measured: Baseline and Week 8

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

    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).

    Measured: Baseline and Week 12

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

    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.

    Measured: Baseline and Week 12

Secondary outcomes (12)

  1. The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg

    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).

    Measured: Baseline and Weeks 2, 4, 6, and 10

  2. The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg

    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.

    Measured: Baseline and Weeks 2, 4, 6, and 10

  3. The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg

    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).

    Measured: Baseline and Weeks 2, 4, 6, 8, 10, and 12

  4. The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg

    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.

    Measured: Baseline and Weeks 2, 4, 6, 8, 10, and 12

  5. The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg

    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).

    Measured: Baseline and Weeks 2, 4, 6, 8, 10, and 12

  6. The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg

    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.

    Measured: Baseline and Weeks 2, 4, 6, 8, 10, and 12

  7. Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg

    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).

    Measured: Baseline and Weeks 2, 4, 6, 8, 10, and 12

  8. Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg

    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.

    Measured: Baseline and Weeks 2, 4, 6, 8, 10, and 12

  9. Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)

    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.

    Measured: At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40

  10. Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)

    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.

    Measured: At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40

  11. Serum PF-04236921 Concentration Over Time

    Measured: Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40

  12. Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)

    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.

    Measured: 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)

Timeline

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

  1. First posted2 Feb 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionSep 2014
  4. Study completionFeb 2015

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01287897
Sponsor's protocol ID
B0151003
Other IDs
2010-023034-23, ANDANTE
Acronym
ANDANTE
Status last verified
Dec 2015
First submitted
31 Jan 2011
Last updated
21 Jan 2016
Data monitoring committee
Yes

Publications

  • Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.

    PubMed 29776017

  • 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 SC injection in people with Crohn's Disease, run by Pfizer at 193 sites in 18 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 4 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States, Israel, United Kingdom, Australia, Brazil and 13 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. Some participants in this study may receive a placebo. 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 21 Jan 2016). 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?

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 mg (time frame: Baseline and Week 8). The study lists 4 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 NCT01287897, which also lists 2 linked publications.

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 21 Jan 2016.

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