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The Safety And Efficacy Of Maintenance Therapy With CP-690,550

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
CP-690,550
CP-690,550
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring tofacitinib, Xeljanz, CP-690,550, maintenance therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
  • Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
  • Women of childbearing potential must test negative for pregnancy prior to study enrolment.

Exclusion Criteria:

  • Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
  • Subjects likely to require any type of surgery during the study period.
  • Fecal culture/toxin assay indicating presence of pathogenic infection.

Sites / Locations

  • ACMG Endoscopy Center
  • ACRI - Phase I, LLC
  • Advanced Clinical Research Institute-Phase 1, LLC
  • West Coast Clinical Trials
  • Alliance Clinical Research
  • Clinical Research Of The Rockies
  • Gasteroenterology Consultants of Clearwater
  • West Coast Endoscopy Center
  • Clinical Research of West Florida, Inc.
  • Shands Endoscopy Center
  • Shands Hospital at the University of Florida
  • Shands Medical Plaza and Cancer Center
  • University of Florida - College of Medicine
  • Gastroenterology Group of Naples
  • Gulfshore Endoscopy Center (Endoscopies Only)
  • North Florida Gastroenterology Research, LLC
  • Internal Medicine Specialists
  • Gastroenterology Associates of Central Georgia, LLC
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Chevy Chase Endoscopy Center
  • Metropolitan Gastroenterology Group, PC
  • East Ann Arbor Health and Geriatrics Center
  • University of Michigan Health Systems
  • Center for Digestive Health
  • Surgical Centers of Michigan
  • NYU Langone Nassau Gastroenterology Associates
  • Premier Medical Group of the Hudson Valley, PC
  • Investigational Drug Services - University Hospitals Case Medical Center
  • University Hospitals Case Medical Center
  • Cleveland Clinic
  • Great Lakes Gastroenterology
  • Digestive Health Specialists of Tyler
  • Endoscopy Center of Tyler
  • University of Utah HSC
  • Cardiology Consultants
  • Digestive & Liver Desease Specialists
  • Metropolitan Gastroenterology Group, P C
  • The Center for Digestive Health
  • Wisconsin Center for Advanced Research - GI Associates, LLC
  • Allegiance Research Specialists
  • GI Associates
  • Nepean Public Hospital
  • Monash Medical Centre
  • Royal Melbourne Hospital
  • AKH Wien Universitaetsklinik fuer Innere Medizin III
  • 4 MBAL Parvo vatreshno otdelenie
  • MBAL Sofiamed OOD, Otdelenie po gastroenterologia
  • Office of Dr. David C. Pearson
  • Office of Drs. Ranjith Andrew Singh and Jamie D. Papp,
  • PerCuro Clinical Research Ltd.
  • London Health Sciences Centre - University Hospital
  • Montreal General Hospital - McGill University Health Centre
  • Hepato-Gastroenterologie HK, s.r.o.
  • RDG centrum s.r.o. (Radiology only)
  • Medial Pharma spol.s.r.o. (Pharmacy only)
  • Hopital Huriez CHRU de Lille
  • Hôpital Haut-Lévêque/Service d hépato-gastroentérologie
  • Charite - Campus Berlin Mitte
  • Charite - Campus Benjamin Franklin
  • Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
  • Universitaetsklinikum Schleswig-Holstein
  • Universitaetsklinikum Ulm, Klinik Fuer Innere Medizin I
  • General Hospital of Athens "Evangelismos",1st Gastroenterology Department
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
  • Pannonia Magánorvosi Centrum Kft
  • Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium
  • Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
  • Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
  • Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium
  • Clinfan Kft.
  • Digestive Disease Institute
  • Meir Medical Center
  • Tel Aviv Sourasky Medical Center
  • The Hospital of Hyogo College of Medicine
  • National Hospital Organization Sendai Medical Center
  • Toho University Sakura Medical Center
  • Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
  • Osaka City University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine
  • ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine
  • VU University Medical Center
  • Academisch Medisch Centrum
  • Kingsbury Hospital
  • Parklands Medical Centre
  • Comite Etico de Investigacion Clinica
  • Hospital Clinic de Barcelona
  • Hospital Universitario de La Princesa
  • Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2
  • Municipal Institution "Odesa Regional Clinical Hospital", Odesa Regional Centre of Gastroenterology.
  • Medical Clinical Research Center of Medical Center "Health Clinic" LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo BID

5mg BID

10mg BID

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

Secondary Outcome Measures

Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
CDAI Score by Week
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity
Change From Baseline in CDAI Score by Week
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity
Kaplan-Meier Estimate of the Rate of Time to Relapse
Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline
Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
C-Reactive Protein (CRP) by Week
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Change From Baseline in CRP by Week
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Fecal Calprotectin by Week
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Change From Baseline in Fecal Calprotectin by Week
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose
Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.

Full Information

First Posted
July 12, 2011
Last Updated
November 10, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01393899
Brief Title
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
tofacitinib, Xeljanz, CP-690,550, maintenance therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Title
5mg BID
Arm Type
Experimental
Arm Title
10mg BID
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablets twice daily
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
oral tablets twice daily
Intervention Type
Drug
Intervention Name(s)
CP-690,550
Intervention Description
oral tablets twice daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
Description
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20
Description
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame
Weeks 4, 8, 12 and 20
Title
Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26
Description
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame
Weeks 4, 8, 12, 20 and 26
Title
Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26
Description
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame
Weeks 4, 8, 12, 20 and 26
Title
Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study
Description
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame
Weeks 4, 8, 12, 20 and 26
Title
Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase
Description
Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame
Weeks 20 and 26
Title
Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase
Description
Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame
Weeks 20 and 26
Title
CDAI Score by Week
Description
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity
Time Frame
Baseline and Weeks 4, 8, 12, 20 and 26
Title
Change From Baseline in CDAI Score by Week
Description
CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity
Time Frame
Weeks 4, 8, 12, 20 and 26
Title
Kaplan-Meier Estimate of the Rate of Time to Relapse
Description
Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame
Weeks 4, 8 12, 20 and 26
Title
Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline
Description
Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame
Week 26
Title
C-Reactive Protein (CRP) by Week
Description
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame
Baseline and Weeks 4, 8, 12, 20 and 26
Title
Change From Baseline in CRP by Week
Description
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame
Weeks 4, 8, 12, 20 and 26
Title
Fecal Calprotectin by Week
Description
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Time Frame
Baseline and Weeks 8, 12 and 26
Title
Change From Baseline in Fecal Calprotectin by Week
Description
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
Time Frame
Weeks 8, 12 and 26
Title
Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose
Description
Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.
Time Frame
Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083. Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083. Women of childbearing potential must test negative for pregnancy prior to study enrolment. Exclusion Criteria: Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study. Subjects likely to require any type of surgery during the study period. Fecal culture/toxin assay indicating presence of pathogenic infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
ACMG Endoscopy Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
ACRI - Phase I, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Clinical Research Institute-Phase 1, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
West Coast Clinical Trials
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Alliance Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Research Of The Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Gasteroenterology Consultants of Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
West Coast Endoscopy Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Shands Endoscopy Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0214
Country
United States
Facility Name
Shands Medical Plaza and Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Florida - College of Medicine
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Gulfshore Endoscopy Center (Endoscopies Only)
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
North Florida Gastroenterology Research, LLC
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Chevy Chase Endoscopy Center
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
East Ann Arbor Health and Geriatrics Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2701
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5000
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Surgical Centers of Michigan
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
NYU Langone Nassau Gastroenterology Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Investigational Drug Services - University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Great Lakes Gastroenterology
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Digestive Health Specialists of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Endoscopy Center of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah HSC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Cardiology Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Digestive & Liver Desease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Metropolitan Gastroenterology Group, P C
City
Washington DC
State/Province
Virginia
ZIP/Postal Code
20006
Country
United States
Facility Name
The Center for Digestive Health
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wisconsin Center for Advanced Research - GI Associates, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
GI Associates
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Nepean Public Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
ZIP/Postal Code
3050
Country
Australia
Facility Name
AKH Wien Universitaetsklinik fuer Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
4 MBAL Parvo vatreshno otdelenie
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
MBAL Sofiamed OOD, Otdelenie po gastroenterologia
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
Office of Dr. David C. Pearson
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6R3
Country
Canada
Facility Name
Office of Drs. Ranjith Andrew Singh and Jamie D. Papp,
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
PerCuro Clinical Research Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czech Republic
Facility Name
RDG centrum s.r.o. (Radiology only)
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czech Republic
Facility Name
Medial Pharma spol.s.r.o. (Pharmacy only)
City
Hradec Králové
ZIP/Postal Code
50012
Country
Czech Republic
Facility Name
Hopital Huriez CHRU de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Haut-Lévêque/Service d hépato-gastroentérologie
City
Pessac Cedex
ZIP/Postal Code
33064
Country
France
Facility Name
Charite - Campus Berlin Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Ulm, Klinik Fuer Innere Medizin I
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
City
Kolonaki Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pannonia Magánorvosi Centrum Kft
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium
City
Budapest
ZIP/Postal Code
H-1044
Country
Hungary
Facility Name
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
City
Budapest
ZIP/Postal Code
H-1076
Country
Hungary
Facility Name
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium
City
Kaposvár
ZIP/Postal Code
H-7400
Country
Hungary
Facility Name
Clinfan Kft.
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Digestive Disease Institute
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel -Aviv
ZIP/Postal Code
64932
Country
Israel
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
City
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Kingsbury Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Parklands Medical Centre
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Comite Etico de Investigacion Clinica
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2
City
Donetsk
ZIP/Postal Code
83017
Country
Ukraine
Facility Name
Municipal Institution "Odesa Regional Clinical Hospital", Odesa Regional Centre of Gastroenterology.
City
Odesa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
Medical Clinical Research Center of Medical Center "Health Clinic" LLC
City
Vinnitsa
ZIP/Postal Code
21029
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
28209624
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921084&StudyName=The%20Safety%20And%20Efficacy%20Of%20Maintenance%20Therapy%20With%20CP-690%2C550%20
Description
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Learn more about this trial

The Safety And Efficacy Of Maintenance Therapy With CP-690,550

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