Clinical trial NCT01470599: A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
Official title: A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Adjudicated Potential Cardiovascular Events
timeFrame: From baseline to Week 52
measure: Adjudicated Malignancy Events
timeFrame: From baseline to Week 52
measure: Adjudicated Hepatic Injury Events
timeFrame: From baseline to Week 52
measure: Adjudicated Opportunistic Infection Events
timeFrame: From baseline to Week 52
measure: Adjudicated Gastrointestinal (GI) Perforation Events
timeFrame: From baseline to Week 52
measure: Adjudicated Interstitial Lung Disease (ILD) Events
timeFrame: From baseline to Week 52
Secondary outcomes:
measure: Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study
timeFrame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
measure: Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study
timeFrame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
measure: Time to Relapse Among Participants in Clinical Remission at Baseline
timeFrame: From baseline to Week 52
measure: Observed CDAI Score by Week
timeFrame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
measure: Change From Baseline Observed CDAI Score by Week
timeFrame: Weeks 8, 16, 24, 36, 48 and 52/follow-up
measure: Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline
timeFrame: Week 48
measure: Corticosteroid Use Over Time
timeFrame: Weeks 8, 16, 24, 36 and 48
measure: Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit
timeFrame: From baseline to Week 48
measure: Observed Change From Baseline in Fecal Calprotectin by Week
timeFrame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
measure: Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week
timeFrame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit
timeFrame: Baseline and Week 48/early termination (ET)
measure: Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit
timeFrame: Baseline and Week 48/ET
measure: Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/ET Visit
timeFrame: Week 48/ET
measure: Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category
timeFrame: Week 48/ET visit
measure: Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit
timeFrame: Baseline and Week 48/ET visit
measure: Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit
timeFrame: Baseline and Week 48/ET visit
measure: EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit
timeFrame: Baseline and Week 48/ET visit
measure: Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit
timeFrame: Baseline and Week 48/ET visit
measure: EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
timeFrame: Baseline and Week 48/ET visit
measure: Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit
timeFrame: Baseline and Week 48/ET visit
measure: Percentage of Participants Hospitalized Due to Crohn's Disease
timeFrame: From baseline to Week 52/follow-up
measure: Length of Hospitalizations Due to Crohn's Disease
timeFrame: From baseline to Week 52/follow-up
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Alliance Clinical Research
state: California
city: Lafayette
country: United States
facility: Clinical Research Of The Rockies
state: Colorado
city: Clearwater
country: United States
facility: Gastroenterology Consultants of Clearwater
state: Florida
city: Clearwater
country: United States
facility: West Coast Endoscopy Center
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Gainesville
country: United States
facility: Shands Endoscopy Center
state: Florida
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: Investigational Drug Service
state: Florida
city: Gainesville
country: United States
facility: Shands Medical Plaza and Cancer Center
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Naples
country: United States
facility: Gulfshore Endoscopy Center (Endoscopies Only)
state: Florida
city: Orange Park
country: United States
facility: North Florida Gastroenterology Research, LLC
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Ann Arbor
country: United States
facility: East Ann Arbor Health and Geriatrics Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Troy
country: United States
facility: Surgical Centers of Michigan
state: Michigan
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Great Neck
country: United States
facility: NYU Langone Nassau Gastroenterology Associates
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Mentor
country: United States
facility: The Endoscopy Center of Lake County
state: Ohio
city: Willoughby
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Endoscopy Center
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Tyler
country: United States
facility: Endoscopy Center of Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah HSC
state: Utah
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research - GI Associates, LLC
state: Wisconsin
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists
state: Wisconsin
city: Wauwatosa
country: United States
facility: GI Associates
state: Wisconsin
city: Kingswood
country: Australia
facility: Nepean Public Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Wien
country: Austria
facility: AKH Wien Universitaetsklinik fuer Innere Medizin III
city: Sofia
country: Bulgaria
facility: 4-MBAL, Parvo vatreshno otdelenie
city: Sofia
country: Bulgaria
facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia
city: Victoria
country: Canada
facility: Office of Dr. David C Pearson
state: British Columbia
city: Victoria
country: Canada
facility: Office of Drs. Ranjith Andrew Singh, Jamie D. Papp
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Limited
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital-Mcgill University Health Centre
state: Quebec
city: Hradec Kralove
country: Czechia
facility: RDG centrum s.r.o.
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Hradec Králové
country: Czechia
facility: Medial Pharma spol.s.r.o.
city: Lille Cedex
country: France
facility: Hopital Huriez - CHRU de Lille
city: Pessac Cedex
country: France
facility: Hôpital Haut-Lévêque
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Kolonaki Athens
country: Greece
facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department
city: Budapest
country: Hungary
facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
city: Budapest
country: Hungary
facility: Pannonia Magánorvosi Centrum Kft
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
city: Szekszard
country: Hungary
facility: Clinfan Kft.
city: Jerusalem
country: Israel
facility: Department of medicine Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: The Hospital of Hyogo College of Medicine
state: Hyogo
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Soeul
country: Korea, Republic of
facility: Asan Medical Center
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Durban
country: South Africa
facility: Parklands Medical Centre
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda Servicio Digestivo - Planta 2
city: Odesa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
city: Vinnitsa
country: Ukraine
facility: Medical Clinical Research Center of Medical Center "Health Clinic" LLC
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Panes J, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072.