A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
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
2 other identifiers
interventional
280
17 countries
137
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Typical duration for phase_2
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
April 28, 2017
CompletedApril 28, 2017
March 1, 2017
3.3 years
July 11, 2011
February 22, 2016
March 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Clinical remission was a CDAI \< 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 antidiarrheal 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. The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Week 8
Secondary Outcomes (19)
Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4
Weeks 2 and 4
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
Baseline, Weeks 2, 4, and 8
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
Baseline, Weeks 2, 4, and 8
Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8
Baseline, Weeks 2, 4, and 8
CDAI Scores at Weeks 2, 4, and 8
Weeks 2, 4, and 8
- +14 more secondary outcomes
Study Arms (3)
Placebo BID
PLACEBO COMPARATOR5mg BID
EXPERIMENTAL10mg BID
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (140)
ACRI - Phase 1, LLC
Anaheim, California, 92801, United States
Advanced Clinical Research Institute - Phase 1, LLC
Anaheim, California, 92801, United States
AGMG Endoscopy Center
Anaheim, California, 92801, United States
Alliance Clinical Research
Oceanside, California, 92056, United States
Alliance Clinical Research, LLC
Poway, California, 92064, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, 92101, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, 92123, United States
Clinical Research Of The Rockies
Lafayette, Colorado, 80026, United States
Endoscopy Center of the Rockies - Longmont
Longmont, Colorado, 80501, United States
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, 06437, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, 06518, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Metropolitan Gastroenterology Group, PC
Washington D.C., District of Columbia, 20006, United States
Gasteroenterology Consultants of Clearwater
Clearwater, Florida, 33756, United States
West Coast Endoscopy Center
Clearwater, Florida, 33756, United States
Clinical Research of West Florida, Inc
Clearwater, Florida, 33765, United States
Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only)
Crystal River, Florida, 34429, United States
Shands Endoscopy Center
Gainesville, Florida, 32608, United States
Shands Hospital at the University of Florida
Gainesville, Florida, 32610-0214, United States
Investigational Drug Service
Gainesville, Florida, 32610, United States
Shands Medical Plaza and Cancer Center
Gainesville, Florida, 32610, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Suncoast Endoscopy Center (Colonoscopy Only)
Inverness, Florida, 34453, United States
FQL Research, LLC
Miramar, Florida, 33025, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Gulfshore Endoscopy Center (Endoscopies Only)
Naples, Florida, 34102, United States
North Florida Gastroenterology Research, LLC
Orange Park, Florida, 32073, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201, United States
Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Heartland Medical Research, Inc (Administrative Only)
Clive, Iowa, 50325, United States
Iowa Digestive Disease Center
Clive, Iowa, 50325, United States
Iowa Endoscopy Center (Colonoscopy Only)
Clive, Iowa, 50325, United States
Iowa Radiology (MRI, X-Ray Only)
Clive, Iowa, 50325, United States
Cotton-O'Neil Clinical (X-Ray)
Topeka, Kansas, 66606, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
Stormont-Vail MRI Center of Kansas
Topeka, Kansas, 66606, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, 20815, United States
Metropolitan Gastroenterology Group, PC
Chevy Chase, Maryland, 20815, United States
East Ann Arbor Health and Geriatrics Center
Ann Arbor, Michigan, 48109-2701, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109-5000, United States
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, 48047, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, 11021, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12601, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207, United States
Charlotte Radiology (Chest X-Ray Only)
Charlotte, North Carolina, 28211, United States
University Hospitals Chagrin Highlands Health Center
Beachwood, Ohio, 44122, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Dayton Gastroenterology, Inc.
Dayton, Ohio, 45415, United States
Great Lakes Gastroenterology
Mentor, Ohio, 44060, United States
The Endoscopy Center of Lake County
Mentor, Ohio, 44060, United States
University Hospitals Westlake Medical Center
Westlake, Ohio, 44145, United States
Great Lakes Gastroenterology
Willoughby, Ohio, 44094, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604, United States
UT Health Science Center
Houston, Texas, 77030, United States
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Cardiology Consultants (ECG Site Only)
Norfolk, Virginia, 23502, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
MRI & CT Diagnostics
Virginia Beach, Virginia, 23455, United States
The Center for Digestive Health
Milwaukee, Wisconsin, 53215, United States
Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin, 53215, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Medical Diagnostic Imaging (MDI) X-ray and MRI only
Milwaukee, Wisconsin, 53222, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, 53226, United States
GI Associates
Wauwatosa, Wisconsin, 53226, United States
Nepean Public Hospital
Kingswood, New South Wales, 2747, Australia
Monash Medical Center
Clayton, Victoria, 3168, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
AKH Wien Universitaetsklinik fuer Innere Medizin III
Vienna, 1090, Austria
4-MBAL, Parvo vatreshno otdelenie
Sofia, 1000, Bulgaria
MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
Sofia, 1431, Bulgaria
MBAL Voennomeditsinska Akademia
Sofia, 1606, Bulgaria
MBAL Sofiamed OOD, Otdelenie po gastroenterologia
Sofia, 1797, Bulgaria
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Office of Dr. David C. Pearson
Victoria, British Columbia, V8R 6R3, Canada
Office of Drs. Ranjith Andrew Singh and Jamie D. Papp
Victoria, British Columbia, V8V 3P9, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8V 3P9, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre
Montreal, Quebec, H3G1A4, Canada
University Hospital Centre Rijeka
Rijeka, 51000, Croatia
University Hospital Center Zagreb
Zagreb, 10000, Croatia
Medial Pharma spol.s.r.o.
Hradec Králové, 500 12, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012, Czechia
RDG centrum s.r.o.
Hradec Králové, 50012, Czechia
Hopital Huriez, CHRU de Lille
Lille, 59037, France
Hopital Haut-Leveque
Pessac, 33064, France
Hopital Robert Debre
Reims, 51092, France
Charite - Campus Berlin Mitte
Berlin, 10117, Germany
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I
Ulm, 89081, Germany
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, 106 76, Greece
Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly
Budapest, 1062, Hungary
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
Budapest, 1076, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum Kft
Budapest, 1136, Hungary
Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium
Budapest, H-1044, Hungary
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft
Gyöngyös, 3200, Hungary
Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly
Kaposvár, 7400, Hungary
Clinfan Kft.
Szekszárd, 7100, Hungary
Digestive Diseases Institute, Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Dept. of Gastroenterology & Hepatology, Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, 060-0033, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyo-ku, Tokyo, 1138519, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Toho University Sakura Medical Center
Chiba, 285-8741, Japan
VU University Medical Center
Amsterdam, 1081 HV, Netherlands
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Kingsbury Hospital
Cape Town, Western Cape, 7708, South Africa
Parklands Medical Centre
Durban, 4091, South Africa
Severance Hospital, Yeonsei University Health System
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
ASAN Medical Center
Seoul, 138-736, South Korea
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, 28006, Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
State Institution "Institute of Gastroenterology of AMS of Ukraine"
Dnipropetrovsk, 49074, Ukraine
Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2,
Donetsk, 83017, Ukraine
State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine"
Kharkiv, 61039, Ukraine
Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course
Lviv, 79010, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
Odesa, 65117, Ukraine
Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed"
Vinnitsa, 21029, Ukraine
Related Publications (1)
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.
PMID: 28209624DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 13, 2011
Study Start
October 1, 2011
Primary Completion
February 1, 2015
Study Completion
March 1, 2015
Last Updated
April 28, 2017
Results First Posted
April 28, 2017
Record last verified: 2017-03