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 July 2015 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470599
First received: October 27, 2011
Last updated: July 30, 2015
Last verified: July 2015
  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: 85
Study Start Date: April 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: July 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 76 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 Recruiting
Oceanside, California, United States, 92056
Alliance Clinical Research, LLC Not yet recruiting
Poway, California, United States, 92064
Sharp Rees-Stealy Gastroenterology Not yet recruiting
San Diego, California, United States, 92101
United States, Colorado
Clinical Research Of The Rockies Not yet recruiting
Lafayette, Colorado, United States, 80026
United States, Florida
Clinical Research of West Florida, Inc. Recruiting
Clearwater, Florida, United States, 33765
Gastroenterology Consultants of Clearwater Recruiting
Clearwater, Florida, United States, 33756
West Coast Endoscopy Center Recruiting
Clearwater, Florida, United States, 33756
Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only) Not yet recruiting
Crystal River, Florida, United States, 34429
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32610
University of Florida - College of Medicine Recruiting
Gainesville, Florida, United States, 32610
Nature Coast Clinical Research Not yet recruiting
Inverness, Florida, United States, 34452
Center for Advanced Gastroenterology Not yet recruiting
Maitland, Florida, United States, 32751
MNH Surgical Center Not yet recruiting
Maitland, Florida, United States, 32751
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 Recruiting
Orange Park, Florida, United States, 32073
Internal Medicine Specialists 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 Not yet recruiting
Topeka, Kansas, United States, 66606
Cotton-O'Neil Clinical Research Center, Digestive Health Not yet recruiting
Topeka, Kansas, United States, 66606
United States, Michigan
East Ann Arbor Health and Geriatrics Center Active, not recruiting
Ann Arbor, Michigan, United States, 48109-2701
University of Michigan Health Systems Active, not 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 Recruiting
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates 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 Radiology Not yet recruiting
Charlotte, North Carolina, United States, 28277
Charlotte Gastroenterology and Hepatology, PLLC Not yet recruiting
Charlotte, North Carolina, United States, 28207
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
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Investigational Drug Services - University Hospitals Case Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
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
Great Lakes Gastroenterology Recruiting
Willoughby, Ohio, United States, 44094
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 Recruiting
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Wisconsin Center for Advanced Research Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Allegiance Research Specialists Active, not recruiting
Wauwatosa, Wisconsin, United States, 53226
GI Associates Active, not recruiting
Wauwatosa, Wisconsin, United States, 53226
Australia, Victoria
Royal Melbourne Hospital Colorectal Medicine and Genetics Active, not recruiting
Melbourne, Victoria, Australia, 3050
Australia
Monash Medical Center Active, not recruiting
Clayton, Australia, 3169
Nepean Clinical School Active, not recruiting
Kingswood, Australia, 2747
Austria
AKH Wien Universitaetsklinik fuer Innere Medizin III Recruiting
Wien, Austria, 1090
Bulgaria
4-MBAL, Parvo vatreshno otdelenie Active, not recruiting
Sofia, Bulgaria, 1000
MBAL Sofiamed OOD, Otdelenie po gastroenterologia Recruiting
Sofia, Bulgaria, 1797
Canada, British Columbia
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
PerCuro Clinical Research Limited Recruiting
Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
London Health Sciences Centre - University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Canada, Quebec
McGill University Health Centre - Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Czech Republic
Hepato-Gastroenterologie HK, s.r.o. Active, not recruiting
Hradec Kralove, Czech Republic, 50012
RDG centrum s.r.o. Active, not recruiting
Hradec Kralove, Czech Republic, 500 12
Medial Pharma spol.s.r.o. Active, not recruiting
Hradec Králové, Czech Republic, 500 12
France
Service d Hepato gastro-enterologie Recruiting
Lille Cedex, France, 59037
Quintiles Laboratories Europe Recruiting
Livingston, France, EH54 7EG
Hôpital Haut-Lévêque Recruiting
Pessac Cedex, France, 33604
Germany
Charite Campus Benjamin Franklin Active, not recruiting
Berlin, Germany, 12200
Universitaetsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Universitaetsklinikum Ulm, Klinik fuer lnnere Medizin II Recruiting
Ulm, Germany, 89081
Greece
General Hospital of Athens "Evangelismos",1st Gastroenterology Department Active, not recruiting
Kolonaki Athens, Greece, 106 76
Hungary
Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium Recruiting
Budapest, Hungary, H-1044
Pannonia Magánorvosi Centrum Kft Recruiting
Budapest, Hungary, 1136
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat Recruiting
Budapest, Hungary, 1076
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia Recruiting
Budapest, Hungary, 1125
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft., Recruiting
Gyongyos, Hungary, 3200
Clinfan Kft. Recruiting
Szekszard, Hungary, 7100
Israel
Pharmacy- Shaare zedek medical center Recruiting
Jerusalem, Israel, 91031
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Dept. of Gastroenterology & Hepatology, Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Rabin Medical Center, Beilinson Hospital Not yet recruiting
Petach Tikva, Israel, 49100
Pharmacy- Tel Aviv sourasky medical center Recruiting
Tel Aviv, Israel, 64239
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Japan
Toho University Sakura Medical Center Active, not recruiting
Sakura, Chiba, Japan, 285-8741
Sapporo-Kosei General Hospital Active, not recruiting
Sapporo, Hokkaido, Japan, 060-0033
The Hospital of Hyogo College of Medicine Active, not recruiting
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organization Sendai Medical Center Active, not recruiting
Sendai, Miyagi, Japan, 983-8520
Toho University Sakura Medical Center Active, not recruiting
Chiba, Sakura, Japan, 285-8741
Toho University Sakura Medical Center Active, not recruiting
Chiba, Japan, 285-8741
Osaka City University Hospital Active, not recruiting
Osaka, Japan, 545-8586
Korea, Republic of
Asan Medical Center Active, not recruiting
Soeul, Korea, Korea, Republic of, 138-736
Samsung Medical Center Active, not recruiting
Seoul, Korea, Republic of, 135-710
Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
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 de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2 Recruiting
Madrid, Spain, 28222
Hospital Universitario de La Princesa Active, not recruiting
Madrid, Spain, 28006
Ukraine
Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology. Recruiting
Odesa, Ukraine, 65117
Medical Clinical Research Center of Medical Center "Health Clinic" LLC 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, 2011-003622-27
Study First Received: October 27, 2011
Last Updated: July 30, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2015