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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470599
First received: October 27, 2011
Last updated: August 16, 2016
Last verified: August 2016
  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 ]

Enrollment: 151
Study Start Date: April 2012
Study Completion Date: July 2016
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   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, California
Alliance Clinical Research
Oceanside, California, United States, 92056
United States, Colorado
Clinical Research Of The Rockies
Lafayette, Colorado, United States, 80026
United States, Florida
Gastroenterology Consultants of Clearwater
Clearwater, Florida, United States, 33756
West Coast Endoscopy Center
Clearwater, Florida, United States, 33756
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Shands Endoscopy Center
Gainesville, Florida, United States, 32608
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610-0214
Investigational Drug Service
Gainesville, Florida, United States, 32610
Shands Medical Plaza and Cancer Center
Gainesville, Florida, United States, 32610
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
Gulfshore Endoscopy Center (Endoscopies Only)
Naples, Florida, United States, 34102
North Florida Gastroenterology Research, LLC
Orange Park, Florida, United States, 32073
Internal Medicine Specialists
Orlando, Florida, United States, 32806
United States, Georgia
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31201
United States, Michigan
East Ann Arbor Health and Geriatrics Center
Ann Arbor, Michigan, United States, 48109-2701
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109-5000
Center For Digestive Health
Troy, Michigan, United States, 48098
Surgical Centers of Michigan
Troy, Michigan, United States, 48098
United States, New York
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States, 11021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
The Endoscopy Center of Lake County
Mentor, Ohio, United States, 44060
Great Lakes Gastroenterology
Willoughby, Ohio, United States, 44094
United States, Texas
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
Endoscopy Center of Tyler
Tyler, Texas, United States, 75701
United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
United States, Virginia
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin, United States, 53215
Allegiance Research Specialists
Wauwatosa, Wisconsin, United States, 53226
GI Associates
Wauwatosa, Wisconsin, United States, 53226
Australia, New South Wales
Nepean Public Hospital
Kingswood, New South Wales, Australia, 2747
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Austria
AKH Wien Universitaetsklinik fuer Innere Medizin III
Wien, Austria, 1090
Bulgaria
4-MBAL, Parvo vatreshno otdelenie
Sofia, Bulgaria, 1000
MBAL Sofiamed OOD, Otdelenie po gastroenterologia
Sofia, Bulgaria, 1797
Canada, British Columbia
Office of Dr. David C Pearson
Victoria, British Columbia, Canada, V8R 6R3
Office of Drs. Ranjith Andrew Singh, Jamie D. Papp
Victoria, British Columbia, Canada, V8V 3P9
PerCuro Clinical Research Limited
Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal General Hospital-Mcgill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Czech Republic
RDG centrum s.r.o.
Hradec Kralove, Czech Republic, 500 12
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czech Republic, 50012
Medial Pharma spol.s.r.o.
Hradec Králové, Czech Republic, 500 12
France
Hopital Huriez - CHRU de Lille
Lille Cedex, France, 59037
Hôpital Haut-Lévêque
Pessac Cedex, France, 33604
Germany
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203
Universitaetsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Greece
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, Greece, 106 76
Hungary
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
Budapest, Hungary, 1076
Pannonia Magánorvosi Centrum Kft
Budapest, Hungary, 1136
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary, H-1125
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
Gyongyos, Hungary, 3200
Clinfan Kft.
Szekszard, Hungary, 7100
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Dept. of Gastroenterology & Hepatology, Meir Medical Center
Kfar Saba, Israel, 44281
Pharmacy- Tel Aviv sourasky medical center
Tel Aviv, Israel, 64239
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan, 060-0033
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan, 983-8520
Toho University Sakura Medical Center
Chiba, Japan, 285-8741
Osaka City University Hospital
Osaka, Japan, 545-8586
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Soeul, Korea, Republic of, 138-736
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
South Africa
Parklands Medical Centre
Durban, South Africa, 4091
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2
Madrid, Spain, 28222
Ukraine
Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
Odesa, Ukraine, 65117
Medical Clinical Research Center of Medical Center "Health Clinic" LLC
Vinnitsa, Ukraine, 21029
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: August 16, 2016
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

ClinicalTrials.gov processed this record on September 28, 2016