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

Crohn's Disease Clinical Trial

— ANDANTE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287897
• Other study ID #: B0151003
• Secondary ID: 2010-023034-23AN
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2011
• Last updated: December 14, 2015
• Start date: February 2011
• Est. completion date: February 2015

Study information

• Verified date: December 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• PF-04236921 SC injection
Placebo delivered SC, 2 doses separated by 4 weeks
• PF-04236921 SC injection
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
• PF-04236921 SC injection
Drug dose level 2 delivered SC, 2 doses separated by 4 weeks

Locations

Country	Name	City	State
Australia	Eastern Health, Box Hill Hospital	Box Hill	Victoria
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St. Vincent's Hospital Melbourne	Fitzroy
Australia	Royal Brisbane and Women's Hospital	Herston, Brisbane	Queensland
Australia	Nepean Public Hospital	Kingswood	New South Wales
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Mater Health Services	South Brisbane	Queensland
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	University Hospital Leuven	Leuven	Vlaams Brabant
Belgium	UZ Leuven Pharmacy	Leuven
Belgium	An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw	Roeselare
Brazil	Hospital Nossa Senhora das Gracas	Curitiba
Brazil	Center X Diagnosticos	Goiania	GO
Brazil	Clinica do Coracao Samaritano	Goiania	GO
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.	Goiania	GO
Brazil	Hospital Sao Lucas da PUCRS	Porto Alegre	RS
Brazil	Hospital Universitário Fraga Filho da UFRJ	Rio de Janeiro	RJ
Brazil	Faculdade de Medicina do ABC	Santo Andre	SP
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	McGill University Health Centre - Royal Victoria Hospital	Montreal	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Czech Republic	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czech Republic	Medial Pharma s.r.o.,	Hradec Kralove
Czech Republic	Fakultni nemocnice Olomouc	Olomouc
Czech Republic	Klinicke centrum ISCARE I.V.F. - gastroenterologie	Prague
Czech Republic	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czech Republic	Institut klinicke a experimentalni mediciny	Praha 4
Czech Republic	IBD Clinical and Research centre	Praha 7
Czech Republic	Krajska zdravotni, a.s.	Usti nad Labem
Denmark	Aalborg Sygehus	Aalborg
Denmark	Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital	Aarhus C
Denmark	Gastroenheden	Herlev
Denmark	Kirurgisk Afdeling 0143	Hilleroed
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Rigshospitalet	Koebenhavn
Denmark	Afdeling I, Gastroenterologisk Sektion	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
France	Hopital de Brabois	Vandoeuvre Les Nancy
Germany	"Charite - Campus Benjamin Franklin	Berlin
Germany	Praxis Dr. Howaldt	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel
Germany	Gastroenterologische Gemeinschaftspraxis Minden	Minden
Germany	Universitaetsklinik Regensburg	Regensburg
Greece	University General Hospital "Attikon"	Athens
Greece	General Hospital of Athens "Evangelismos",1st Gastroenterology Department	Kolonaki Athens
Hungary	Pannonia Maganorvosi Centrum Kft.	Budapest
Hungary	Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika	Budapest
Hungary	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai	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	Beaumont Hospital	Dublin
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 4
Ireland	University Hospital Galway	Galway
Israel	Institute of Gastroenterology	Haifa
Israel	The E. Wolfson Medical Center	Holon
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Dept of Gastroenterology & Hepatology	Kfar Saba
Israel	Rabin Medical Center, Beilinson Hospital	Petach Tikva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	The Institute Of Gastroenterology & Liver Diseases	Tel Hashomer	Ramat Gan
Israel	Assaf Harofeh Medical Center	Zerifin
Italy	Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi	Bologna
Italy	Azienda Ospedaliera - Universita di Padova	Padova
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma
Italy	Policlinico Tor Vergata	Roma
Italy	Università Campus Biomedico	Roma
Italy	A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and	Rome	Province of Rome
Italy	Istituto Clinico Humanitas IRCCS	Rozzano	Milano
Italy	Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva	San Giovanni Rotondo Fg	Foggia
New Zealand	Christchurch Hospital	Christchurch	Canterbury
New Zealand	Department of Gastroenterology Research	Hamilton	Waikato
New Zealand	Shakespeare Specialist Group	Milford	Auckland
New Zealand	P3 Research Limited	Wellington
Romania	Spitalul Clinic Colentina	Bucuresti	Sector 2
Switzerland	Universitaetsspital Zuerich	Zuerich
United Kingdom	Addenbrooke's Hospital, Department of Gastroenterology	Cambridge
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Hull and East Yorkshire Hospitals NHS Trust	Hull	East Yorkshire
United Kingdom	Pharmacy Department	Hull
United Kingdom	Barts and The London NHS Trust	London
United Kingdom	Royal Free Hospital (Royal Free London NHS Foundation Trust)	London
United Kingdom	Royal Victoria Hospital	Newcastle-upon-Tyne
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust	Wolverhampton
United States	Central Indiana Gastroenterology Group	Anderson	Indiana
United States	Saint John's Research Institute	Anderson	Indiana
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Digestive Disorders Associates	Annapolis	Maryland
United States	Disgestive Disorders Associates	Annapolis	Maryland
United States	Investigative Clinical Research	Annapolis	Maryland
United States	Maryland Diagnostics & Therapeutic Endo Center	Annapolis	Maryland
United States	Illinois Gastroenterology Group, LLC	Arlington Heights	Illinois
United States	Professional Quality Research, Inc.	Austin	Texas
United States	UAB Hospital	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	The University Of Chicago	Chicago	Illinois
United States	The University of Chicago Medical	Chicago	Illinois
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	The University of Chicago Medical Center (Ucmc)	Chicago	Illinois
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Gastroenterology Associates	Crystal River	Florida
United States	Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia
United States	Atlanta Endoscopy Center	Decatur	Georgia
United States	Decatur Health Imaging	Decatur	Georgia
United States	Rocky Mountain Clinical Research, LLC	Denver	Colorado
United States	Pharma Resource	East Providence	Rhode Island
United States	NorthShore University Health System	Evanston	Illinois
United States	Prima CARE, PC	Fall River	Massachusetts
United States	Gastro One	Germantown	Tennessee
United States	Glenbrook Hospital	Glenview	Illinois
United States	Glenbrook Hospital Outpatient Pharmacy	Glenview	Illinois
United States	East Valley Endoscopy	Grand Rapids	Michigan
United States	Endoscopy Center of Connecticut, LLC	Guilford	Connecticut
United States	Endoscopy Center of Connecticut, LLC	Hamden	Connecticut
United States	Gastroenterology Center of Connecticut, PC	Hamden	Connecticut
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Baylor Clinic (Drug Storage)	Houston	Texas
United States	Baylor College of Medicine - Baylor Medical Center	Houston	Texas
United States	Diagnostic Clinic of Houston, PA	Houston	Texas
United States	Ertan Digestive Disease Center	Houston	Texas
United States	Houston Hospital for Specialized Surgery (Endoscopy Only)	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	Physicians Endoscopy Center (Colonoscopy)	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	The University of Texas Medical School at Houston	Houston	Texas
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Suncoast Endoscopy Center	Inverness	Florida
United States	Rocky Mountain Gastroenterology	Lakewood	Colorado
United States	Rocky Mountain Gastroenterology Associates	Lakewood	Colorado
United States	University of Kentucky	Lexington	Kentucky
United States	Arapahoe Gastroenterology, PC	Littleton	Colorado
United States	University Of Louisville	Louisville	Kentucky
United States	University Of Louisville Healthcare Outpatient Center	Louisville	Kentucky
United States	University of Louisville Research Foundation	Louisville	Kentucky
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	GI Diagnostics	Marietta	Georgia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Advanced Research Institute, Inc.	New Port Richey	Florida
United States	Arthur asher Kornbluth, MD PC	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	New York Presbyterian Hospital	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	Minnesota Gastroenterology, PA	Plymouth	Minnesota
United States	VCU Medical Investigational Drug Service (IDS)	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University Of Utah HSC	Salt Lake City	Utah
United States	UCSF Endoscopy Unit at Mount Zion	San Francisco	California
United States	University of California - San Francisco	San Francisco	California
United States	University of California San Francisco at Mount Zion	San Francisco	California
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	One Step Diagnostic (X-Ray)	Sugar Land	Texas
United States	Pioneer Research Solutions, Inc. (Admin. Office)	Sugar Land	Texas
United States	Pioneer Research Solutions, Inc.	SugarLand	Texas
United States	Adobe Clinical Research, Llc	Tucson	Arizona
United States	Radiology Ltd	Tucson	Arizona
United States	Advanced Imaging	Tulsa	Oklahoma
United States	Hillcrest Medical Center	Tulsa	Oklahoma
United States	Hillcrest Medical Center Endoscopy	Tulsa	Oklahoma
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Utica Park Clinic X-Ray	Tulsa	Oklahoma
United States	Digestive Health Specialists of Tyler	Tyler	Texas
United States	Omega Medical Research	Warwick	Rhode Island
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
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
United States	St. Joseph Mercy Hospital	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  New Zealand,  Romania,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and Week 8	No
Primary	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.	Baseline and Week 8	No
Primary	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).	Baseline and Week 12	No
Primary	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.	Baseline and Week 12	No
Secondary	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).	Baseline and Weeks 2, 4, 6, and 10	No
Secondary	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.	Baseline and Weeks 2, 4, 6, and 10	No
Secondary	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).	Baseline and Weeks 2, 4, 6, 8, 10, and 12	No
Secondary	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.	Baseline and Weeks 2, 4, 6, 8, 10, and 12	No
Secondary	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).	Baseline and Weeks 2, 4, 6, 8, 10, and 12	No
Secondary	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.	Baseline and Weeks 2, 4, 6, 8, 10, and 12	No
Secondary	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).	Baseline and Weeks 2, 4, 6, 8, 10, and 12	No
Secondary	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.	Baseline and Weeks 2, 4, 6, 8, 10, and 12	No
Secondary	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.	At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40	Yes
Secondary	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.	At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40	Yes
Secondary	Serum PF-04236921 Concentration Over Time		Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40	No
Secondary	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.	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)	Yes

External Links

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