Clinical trial NCT01393626: A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands).
* Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.
* Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

Exclusion Criteria:

* Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
* Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve).
* Subjects receiving the following treatment for Crohn's disease:
* Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
* Anti-TNFα therapy within 8 weeks prior to baseline.
* Interferon therapy within 8 weeks prior to baseline.
* Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
* Intravenous corticosteroids within 2 weeks prior to baseline.

Primary outcomes:
measure: Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4
timeFrame: Weeks 2 and 4
measure: Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8
timeFrame: Baseline, Weeks 2, 4, and 8
measure: Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8
timeFrame: Baseline, Weeks 2, 4, and 8
measure: Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8
timeFrame: Baseline, Weeks 2, 4, and 8
measure: CDAI Scores at Weeks 2, 4, and 8
timeFrame: Weeks 2, 4, and 8
measure: C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8
timeFrame: Weeks 2, 4, and 8
measure: Calprotectin Fecal Concentrations at Weeks 2, 4, and 8
timeFrame: Weeks 2, 4, and 8
measure: Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit
timeFrame: Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit
timeFrame: Baseline, Week 8/ET visit
measure: Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA)
timeFrame: Baseline, Week 8/ET visit
measure: Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit
timeFrame: Week 8/ET visit
measure: Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit
timeFrame: Week 8/ET visit
measure: Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category
timeFrame: Week 8/ET visit
measure: Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit
timeFrame: Baseline, Week 8/ET visit
measure: Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA
timeFrame: Baseline, Week 8/ET visit
measure: EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit
timeFrame: Baseline, Week 8/ET visit
measure: Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA
timeFrame: Baseline, Week 8/ET visit
measure: EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
timeFrame: Baseline, Week 8/ET visit
measure: Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA
timeFrame: Baseline, Week 8/ET visit
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: ACRI - Phase 1, LLC
state: California
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute - Phase 1, LLC
state: California
city: Anaheim
country: United States
facility: AGMG Endoscopy Center
state: California
city: Oceanside
country: United States
facility: Alliance Clinical Research
state: California
city: Poway
country: United States
facility: Alliance Clinical Research, LLC
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group, Inc.
state: California
city: Lafayette
country: United States
facility: Clinical Research Of The Rockies
state: Colorado
city: Longmont
country: United States
facility: Endoscopy Center of the Rockies - Longmont
state: Colorado
city: Guilford
country: United States
facility: Endoscopy Center of Connecticut, LLC
state: Connecticut
city: Hamden
country: United States
facility: Endoscopy Center of Connecticut, LLC
state: Connecticut
city: Hamden
country: United States
facility: Gastroenterology Center of Connecticut, PC
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Washington
country: United States
facility: Metropolitan Gastroenterology Group, PC
state: District of Columbia
city: Clearwater
country: United States
facility: Gasteroenterology Consultants of Clearwater
state: Florida
city: Clearwater
country: United States
facility: West Coast Endoscopy Center
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc
state: Florida
city: Crystal River
country: United States
facility: Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only)
state: Florida
city: Gainesville
country: United States
facility: Shands Endoscopy Center
state: Florida
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: Investigational Drug Service
state: Florida
city: Gainesville
country: United States
facility: Shands Medical Plaza and Cancer Center
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Inverness
country: United States
facility: Suncoast Endoscopy Center (Colonoscopy Only)
state: Florida
city: Miramar
country: United States
facility: FQL Research, LLC
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Naples
country: United States
facility: Gulfshore Endoscopy Center (Endoscopies Only)
state: Florida
city: Orange Park
country: United States
facility: North Florida Gastroenterology Research, LLC
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Clive
country: United States
facility: Heartland Medical Research, Inc (Administrative Only)
state: Iowa
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Clive
country: United States
facility: Iowa Endoscopy Center (Colonoscopy Only)
state: Iowa
city: Clive
country: United States
facility: Iowa Radiology (MRI, X-Ray Only)
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical (X-Ray)
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Topeka
country: United States
facility: Stormont-Vail MRI Center of Kansas
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, PC
state: Maryland
city: Ann Arbor
country: United States
facility: East Ann Arbor Health and Geriatrics Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan LLC
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Great Neck
country: United States
facility: NYU Langone Nassau Gastroenterology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, PLLC
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Radiology (Chest X-Ray Only)
state: North Carolina
city: Beachwood
country: United States
facility: University Hospitals Chagrin Highlands Health Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dayton
country: United States
facility: Dayton Gastroenterology, Inc.
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Mentor
country: United States
facility: The Endoscopy Center of Lake County
state: Ohio
city: Westlake
country: United States
facility: University Hospitals Westlake Medical Center
state: Ohio
city: Willoughby
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Houston
country: United States
facility: UT Health Science Center
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
state: Utah
city: Norfolk
country: United States
facility: Cardiology Consultants (ECG Site Only)
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Virginia Beach
country: United States
facility: MRI & CT Diagnostics
state: Virginia
city: Milwaukee
country: United States
facility: The Center for Digestive Health
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research - GI Associates, LLC
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical Diagnostic Imaging (MDI) X-ray and MRI only
state: Wisconsin
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists
state: Wisconsin
city: Wauwatosa
country: United States
facility: GI Associates
state: Wisconsin
city: Kingswood
country: Australia
facility: Nepean Public Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Medical Center
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Wien
country: Austria
facility: AKH Wien Universitaetsklinik fuer Innere Medizin III
city: Sofia
country: Bulgaria
facility: 4-MBAL, Parvo vatreshno otdelenie
city: Sofia
country: Bulgaria
facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
city: Sofia
country: Bulgaria
facility: MBAL Voennomeditsinska Akademia
city: Sofia
country: Bulgaria
facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Victoria
country: Canada
facility: Office of Dr. David C. Pearson
state: British Columbia
city: Victoria
country: Canada
facility: Office of Drs. Ranjith Andrew Singh and Jamie D. Papp
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital - McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre
state: Quebec
city: Rijeka
country: Croatia
facility: University Hospital Centre Rijeka
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Hradec Kralove
country: Czech Republic
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Hradec Kralove
country: Czech Republic
facility: RDG centrum s.r.o.
city: Hradec Králové
country: Czech Republic
facility: Medial Pharma spol.s.r.o.
city: Lille Cedex
country: France
facility: Hopital Huriez, CHRU de Lille
city: Pessac
country: France
facility: Hopital Haut-Leveque
city: Reims cedex
country: France
facility: Hopital Robert Debre
city: Berlin
country: Germany
facility: Charite - Campus Berlin Mitte
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I
city: Kolonaki Athens
country: Greece
facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department
city: Budapest
country: Hungary
facility: Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly
city: Budapest
country: Hungary
facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft
city: Budapest
country: Hungary
facility: Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft
city: Kaposvar
country: Hungary
facility: Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly
city: Szekszard
country: Hungary
facility: Clinfan Kft.
city: Jerusalem
country: Israel
facility: Digestive Diseases Institute, Shaare Zedek Medical Center
city: Kfar-Saba
country: Israel
facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
state: Hyogo
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yeonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Cape Town
country: South Africa
facility: Kingsbury Hospital
state: Western Cape
city: Durban
country: South Africa
facility: Parklands Medical Centre
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Dnipropetrovsk
country: Ukraine
facility: State Institution "Institute of Gastroenterology of AMS of Ukraine"
city: Donetsk
country: Ukraine
facility: Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2,
city: Kharkiv
country: Ukraine
facility: State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine"
city: Lviv
country: Ukraine
facility: Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course
city: Odesa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
city: Vinnitsa
country: Ukraine
facility: Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed"
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.