Clinical trial NCT01393899: The Safety And Efficacy Of Maintenance Therapy With CP-690,550
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: tofacitinib
Xeljanz
CP-690,550
maintenance therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI\<150) at Week 8.


Eligibility criteria: Inclusion Criteria:

* Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
* Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI\<150) in Study A3921083.
* Women of childbearing potential must test negative for pregnancy prior to study enrolment.

Exclusion Criteria:

* Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
* Subjects likely to require any type of surgery during the study period.
* Fecal culture/toxin assay indicating presence of pathogenic infection.

Primary outcomes:
measure: Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
timeFrame: Week 26
Secondary outcomes:
measure: Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20
timeFrame: Weeks 4, 8, 12 and 20
measure: Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26
timeFrame: Weeks 4, 8, 12, 20 and 26
measure: Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26
timeFrame: Weeks 4, 8, 12, 20 and 26
measure: Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study
timeFrame: Weeks 4, 8, 12, 20 and 26
measure: Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase
timeFrame: Weeks 20 and 26
measure: Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase
timeFrame: Weeks 20 and 26
measure: CDAI Score by Week
timeFrame: Baseline and Weeks 4, 8, 12, 20 and 26
measure: Change From Baseline in CDAI Score by Week
timeFrame: Weeks 4, 8, 12, 20 and 26
measure: Kaplan-Meier Estimate of the Rate of Time to Relapse
timeFrame: Weeks 4, 8 12, 20 and 26
measure: Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline
timeFrame: Week 26
measure: C-Reactive Protein (CRP) by Week
timeFrame: Baseline and Weeks 4, 8, 12, 20 and 26
measure: Change From Baseline in CRP by Week
timeFrame: Weeks 4, 8, 12, 20 and 26
measure: Fecal Calprotectin by Week
timeFrame: Baseline and Weeks 8, 12 and 26
measure: Change From Baseline in Fecal Calprotectin by Week
timeFrame: Weeks 8, 12 and 26
measure: Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose
timeFrame: Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: ACMG Endoscopy Center
state: California
city: Anaheim
country: United States
facility: ACRI - Phase I, LLC
state: California
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute-Phase 1, LLC
state: California
city: Cypress
country: United States
facility: West Coast Clinical Trials
state: California
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: Gasteroenterology 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: Shands Medical Plaza and Cancer Center
state: Florida
city: Gainsville
country: United States
facility: University of Florida - College of Medicine
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: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, PC
state: Maryland
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 Nassau Gastroenterology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Cleveland
country: United States
facility: Investigational Drug Services - University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
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: Cardiology Consultants
state: Virginia
city: Norfolk
country: United States
facility: Digestive & Liver Desease Specialists
state: Virginia
city: Washington DC
country: United States
facility: Metropolitan Gastroenterology Group, P C
state: Virginia
city: Milwaukee
country: United States
facility: The Center for Digestive Health
state: Wisconsin
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: Melbourne
country: Australia
facility: Royal Melbourne Hospital
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 and Jamie D. Papp,
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
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: Czech Republic
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Hradec Kralove
country: Czech Republic
facility: RDG centrum s.r.o. (Radiology only)
city: Hradec Králové
country: Czech Republic
facility: Medial Pharma spol.s.r.o. (Pharmacy only)
city: Lille Cedex
country: France
facility: Hopital Huriez CHRU de Lille
city: Pessac Cedex
country: France
facility: Hôpital Haut-Lévêque/Service d hépato-gastroentérologie
city: Berlin
country: Germany
facility: Charite - Campus Berlin Mitte
city: Berlin
country: Germany
facility: Charite - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm, Klinik Fuer Innere Medizin I
city: Kolonaki Athens
country: Greece
facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
city: Budapest
country: Hungary
facility: Pannonia Magánorvosi Centrum Kft
city: Budapest
country: Hungary
facility: Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium
city: Budapest
country: Hungary
facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,
city: Kaposvár
country: Hungary
facility: Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium
city: Szekszard
country: Hungary
facility: Clinfan Kft.
city: Jerusalem
country: Israel
facility: Digestive Disease Institute
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel -Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
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: Hokkaido
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Cape Town
country: South Africa
facility: Kingsbury Hospital
state: Western Cape
city: Durban
country: South Africa
facility: Parklands Medical Centre
city: Barcelona
country: Spain
facility: Comite Etico de Investigacion Clinica
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Donetsk
country: Ukraine
facility: Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #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, 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.