A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470599
First received: October 27, 2011
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.


Condition Intervention Phase
Crohn's Disease
Drug: CP-690,550
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Incidence and severity of clinical laboratory abnormalities, and change from baseline in clinical laboratory values. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Incidence of clinically significant changes in physical examination from baseline. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Incidence of vital sign abnormalities and changes from baseline in vital sign measures. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Incidence of electrocardiogram (ECG) abnormalities and change from baseline in ECG measurements during treatment. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Summary of adjudicated cardiovascular endpoints (which will include number of subjects with confirmed diagnosis of angina, chronic heart failure, ischaemic heart disease, myocardial infarction, mortality, PAVD, stroke and transient Ischaemic attacks. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Summary of malignancies confirmed by central laboratory pathologist over-read of biopsies. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sustained clinical remission is defined as being in clinical remission at both Week 24 and Week 48. [ Time Frame: WEEKS 24 AND 48 ] [ Designated as safety issue: No ]
  • The proportion of all enrolled subjects in clinical remission and sustained clinical remission at Week 48. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • The proportions of subjects in clinical remission and sustained clinical remission among subjects in clinical remission at A3921086 baseline. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • The proportion of subjects in clinical remission and sustained clinical remission among subjects in clinical response (CDAI-100 response from Study A3921083 baseline) or clinical remission at A3921086 baseline. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • The median time to relapse among subjects in clinical remission at baseline. Relapse is defined as increase in CDAI of >100 points from the baseline and an absolute CDAI score of >220 points. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • CDAI scores over time and change from baseline in CDAI scores. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving a steroid-free clinical remission at Week 48 among subjects on steroids at baseline. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • Corticosteroid use over time. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • Serum CRP and fecal calprotectin over time and change from baseline in CRP and fecal calprotectin. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5mg BID Drug: CP-690,550
ORAL TABLET, TWICE DAILY
Experimental: 10mg BID Drug: CP-690,550
ORAL TABLETS, TWICE DAILY

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
  • Women of childbearing potential must test negative for pregnancy prior to study enrolment.
  • Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

Exclusion Criteria:

  • Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
  • Subjects who were discontinued from the A3921084 study due to an adverse event.
  • Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470599

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
Advanced Clinical Research Institute - Phase 1, LLC Not yet recruiting
Anaheim, California, United States, 92801
AGMG Endoscopy Center Not yet recruiting
Anaheim, California, United States, 92801
West Coast Clinical Trials Not yet recruiting
Cypress, California, United States, 90630
Alliance Clinical Research Not yet recruiting
Oceanside, California, United States, 92056
Sharp Rees-Stealy Gastroenterology Not yet recruiting
San Diego, California, United States, 92101
United States, Florida
Gastroenterology Consultants of Clearwater Not yet recruiting
Clearwater, Florida, United States, 33756
Clinical Research of West Florida, Inc. Not yet recruiting
Clearwater, Florida, United States, 33765
West Coast Endoscopy Center Not yet recruiting
Clearwater, Florida, United States, 33756
Shands Endoscopy Center Recruiting
Gainesville, Florida, United States, 32608
Investigational Drug Service Recruiting
Gainesville, Florida, United States, 32610
Shands Medical Plaza and Cancer Institute Recruiting
Gainesville, Florida, United States, 32610
FQL Research, LLC Not yet recruiting
Miramar, Florida, United States, 33025
Gastroenterology Group of Naples Active, not recruiting
Naples, Florida, United States, 34102
North Florida Gastroenterology Research, LLC Not yet recruiting
Orange Park, Florida, United States, 32073
Internal Medicine Specialists Not yet recruiting
Orlando, Florida, United States, 32806
Florida Medical Clinic, P.A. Not yet recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Gastroenterology Associates of Central Georgia, LLC Recruiting
Macon, Georgia, United States, 31201
United States, Illinois
Southwest Gastroenterology Not yet recruiting
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health Not yet recruiting
Topeka, Kansas, United States, 66606
Cotton-O'Neil Clinical Research Center Not yet recruiting
Topeka, Kansas, United States, 66606
United States, Michigan
University of Michigan Health Systems Not yet recruiting
Ann Arbor, Michigan, United States, 48109-5000
Clinical Research Institute of Michigan, LLC Not yet recruiting
Chesterfield, Michigan, United States, 48047
Center for Digestive Health Recruiting
Troy, Michigan, United States, 48098
Utica Surgery Center Not yet recruiting
Utica, Michigan, United States, 48317
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
NYU Langone Long Island Clinical Research Associates Not yet recruiting
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates Not yet recruiting
Great Neck, New York, United States, 11021
Premier Medical Group of the Hudson Valley, PC Not yet recruiting
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Charlotte Gastroenterology & Hepatology, PLLC Not yet recruiting
Charlotte, North Carolina, United States, 28207
Charlotte Gastroenterology and Hepatology, PLLC Not yet recruiting
Charlotte, North Carolina, United States, 28207
Charlotte Radiology Not yet recruiting
Charlotte, North Carolina, United States, 28277
Charlotte Radiology Not yet recruiting
Huntersville, North Carolina, United States, 28078
United States, Ohio
Dayton Gastroenterology, Inc. Not yet recruiting
Beavercreek, Ohio, United States, 45440
University Hospitals Case Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Investigational Drug Services - University Hospitals Case Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Great Lakes Gastroenterology Recruiting
Mentor, Ohio, United States, 44060
The Endoscopy Center of Lake County Recruiting
Mentor, Ohio, United States, 44060
United States, Texas
Digestive Health Specialists of Tyler Recruiting
Tyler, Texas, United States, 75701
Endoscopy Center of Tyler Recruiting
Tyler, Texas, United States, 75701
United States, Utah
University of Utah HSC Recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
Digestive & Liver Desease Specialists Not yet recruiting
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Wisconsin Center for Advanced Research Recruiting
Milwaukee, Wisconsin, United States, 53215
Allegiance Research Specialists Not yet recruiting
Wauwatosa, Wisconsin, United States, 53226
GI Associates Not yet recruiting
Wauwatosa, Wisconsin, United States, 53226
Australia, New South Wales
Nepean Clinical School Recruiting
Kingswood, New South Wales, Australia, 2747
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3169
Royal Melbourne Hospital Colorectal Medicine and Genetics Recruiting
Melbourne, Victoria, Australia, 3050
Bulgaria
4-MBAL, Parvo vatreshno otdelenie Not yet recruiting
Sofia, Bulgaria, 1000
MBAL Sofiamed OOD, Otdelenie po gastroenterologia Not yet recruiting
Sofia, Bulgaria, 1797
Canada, British Columbia
Can-Med Clinical Research Inc. Recruiting
Victoria, British Columbia, Canada, V8T 5G1
PerCuro Clinical Research Limited Recruiting
Victoria, British Columbia, Canada, V8V 3P9
Office of Dr. David C. Pearson Recruiting
Victoria, British Columbia, Canada, V8R 6R3
Office of Drs Ranjit A. Singh, Jamie D. Papp Recruiting
Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
London Health Sciences Centre - University Hospital Not yet recruiting
London, Ontario, Canada, N6A 5A5
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Maisonneuve-Rosemont Hospital Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Czech Republic
Hepato-Gastroenterologie HK, s.r.o. Not yet recruiting
Hradec Kralove, Czech Republic, 50012
Medial Pharma spol.s.r.o. Not yet recruiting
Hradec Králové, Czech Republic, 500 12
Fakultni nemocnice Olomouc Not yet recruiting
Olomouc, Czech Republic, 775 20
Masarykova nemocnice Usti nad Labem, o.z. Not yet recruiting
Usti nad Labem, Czech Republic, 401 13
France
Service d Hepato gastro-enterologie Not yet recruiting
Lille Cedex, France, 59037
Quintiles Laboratories Europe Not yet recruiting
Livingston, France, EH54 7EG
Hôpital Haut-Lévêque Not yet recruiting
Pessac Cedex, France, 33604
Hopital Robert Debre, Service D'Hepato-gastro-enterologie et de Cancerologie Digestive Not yet recruiting
Reims CEDEX, France, 51092
Germany
Charite Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum Not yet recruiting
Berlin, Germany, 13353
KLG Krankenhaus-Labor-Gesellschaft mbh am Markus Krankenhaus Not yet recruiting
Frankfurt, Germany, 60487
Agaplesion Markus Krankenhaus Not yet recruiting
Frankfurt am Main, Germany, 60431
Universitaetsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Gastroenterologische Gemeinschaftspraxis Minden Not yet recruiting
Minden, Germany, 32423
Greece
General Hospital of Athens "Evangelismos",1st Gastroenterology Department Recruiting
Kolonaki Athens, Greece, 106 76
Hungary
Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium Recruiting
Budapest, Hungary, H-1044
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak Recruiting
Budapest, Hungary, 1125
Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium Not yet recruiting
Budapest, Hungary, H-1044
Pannonia Magánorvosi Centrum Kft Recruiting
Budapest, Hungary, 1136
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat Not yet recruiting
Budapest, Hungary, 1076
Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium Recruiting
Kaposvár, Hungary, H-7400
Clinfan Kft. Recruiting
Szekszard, Hungary, 7100
Israel
Pharmacy- Shaare zedek medical center Not yet recruiting
Jerusalem, Israel, 91031
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Rabin Medical Center, Beilinson Hospital Not yet recruiting
Petach Tikva, Israel, 49100
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Pharmacy- Tel Aviv sourasky medical center Recruiting
Tel Aviv, Israel, 64239
Japan
Fukuoka University Chikushi Hospital Not yet recruiting
Chikushino, Fukuoka, Japan
National Hospital Organization Fukuyama Medical Center Recruiting
Fukuyama, Hiroshima, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital Recruiting
Sapporo, Hokkaido, Japan
The Hospital of Hyogo College of Medicine Not yet recruiting
Nishinomiya, Hyogo, Japan
National Hospital Organization Sendai Medical Center Completed
Sendai, Miyagi, Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine Not yet recruiting
Bunkyo-ku, Tokyo, Japan
Toho University Sakura Medical Center Recruiting
Chiba, Japan
Osaka City University Hospital Recruiting
Osaka, Japan
Korea, Republic of
Asan Medical Center Recruiting
Soeul, Korea, Korea, Republic of, 138-736
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Severance Hospital, Yeonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 120-752
Netherlands
University Medical Center Groningen (UMCG) Not yet recruiting
Groningen, GZ, Netherlands, 9713
VU University Medical Center Not yet recruiting
Amsterdam, Netherlands, 1081 HV
Universitair Medisch Centrum St. Radboud Not yet recruiting
Nijmegen, Netherlands, 6525 GA
South Africa
Kingsbury Hospital Not yet recruiting
Cape Town, Western Cape, South Africa, 7708
Parklands Medical Centre Recruiting
Durban, South Africa, 4091
Spain
Hospital Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Hospital Universitario Puerta de Hierro Not yet recruiting
Madrid, Spain, 28222
Ukraine
State Institution "Institute of Gastroenterology of AMS of Ukraine" Not yet recruiting
Dnepropetrovsk, Ukraine, 49074
Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2 Not yet recruiting
Donetsk, Ukraine, 83017
State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine" Not yet recruiting
Kharkiv, Ukraine, 61039
Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery #1 with Proctology Course Not yet recruiting
Lviv, Ukraine, 79010
Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology. Not yet recruiting
Odesa, Ukraine, 65117
Medical Clinical Research Center of Medical Center "Health Clinic" LLC Not yet recruiting
Vinnitsa, Ukraine, 21029
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470599     History of Changes
Other Study ID Numbers: A3921086
Study First Received: October 27, 2011
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014