Clinical trial NCT01309737: A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
Official title: A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Xeljanz
tofacitinib
Jak-inhibitor
oral treatment
chronic
severe
moderate
Pruritus
Itch
DLQI
treatment
safety
efficacy
CP-690,550
Plaque Psoriasis
Psoriasis Vulgaris
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.


Eligibility criteria: Inclusion Criteria:

* 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
* A Psoriasis Area and Severity Index (PASI) score of 12 or greater
* Are considered to be candidates for systemic or light therapy
* Have no evidence of active or latent tuberculosis

Exclusion Criteria:

* Non-plaque or drug-induced forms of psoriasis
* Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
* Any uncontrolled significant medical condition

Primary outcomes:
measure: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16
timeFrame: Week 16
measure: Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16
timeFrame: Baseline, Week 4,16
measure: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4
timeFrame: Week 4
measure: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4
timeFrame: Week 4
measure: Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16
timeFrame: Baseline, Week 16
measure: Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52
timeFrame: Week 52
measure: Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52
timeFrame: Week 52
measure: Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52
timeFrame: Week 52
measure: Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
timeFrame: Baseline up to Week 16
measure: Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response
timeFrame: Baseline up to Week 16
measure: Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
timeFrame: Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52
measure: Psoriasis Area and Severity Index (PASI) Component Scores
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
timeFrame: Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
timeFrame: Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52
measure: Total Body Surface Area (BSA) With Psoriasis
timeFrame: Baseline, Week 2, 4, 8,16, 20, 28, 40, 52
measure: Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response
timeFrame: Week 2, 4, 8,12,16, 20, 28, 40, 52
measure: Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response
timeFrame: Week 2, 4, 8,12,16, 20, 28, 40, 52
measure: Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score
timeFrame: Week 2, 4, 8,12,16, 20, 28, 40, 52
measure: Nail Psoriasis Severity Index (NAPSI) Score
timeFrame: Baseline, Week 8, 16, 20, 28, 40, 52
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52
timeFrame: Baseline,Week 8, 16, 20, 28, 40, 52
measure: Number of Affected Nails
timeFrame: Baseline, Week 8, 16, 20, 28, 40, 52
measure: Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52
timeFrame: Baseline,Week 8,16, 20, 28, 40, 52
measure: Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response
timeFrame: Week 8, 16, 20, 28, 40, 52
measure: Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response
timeFrame: Week 8,16, 20, 28, 40, 52
measure: Itch Severity Item (ISI) Score
timeFrame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
measure: Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
timeFrame: Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52
measure: Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: 36-Item Short-Form Health Survey Version 2, Acute (SF-36)
timeFrame: Baseline, Week 16, 28, 52
measure: Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Baseline, Week 8, 16, 28, 52
measure: Work Limitation Questionnaire (WLQ) Index Score
timeFrame: Baseline, Week 8, 16, 28, 52
measure: Percentage of Participants With Patient Global Assessment (PtGA) Scale Response
timeFrame: Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52
measure: Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response
timeFrame: Week 16, 28, 52
measure: Joint Pain Assessment (JPA) Score
timeFrame: Baseline, Week 8,16, 28, 52
measure: Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score
timeFrame: Baseline, Week 16, 28, 40, 52
measure: Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)
timeFrame: Baseline,Week 16, 28, 40, 52
measure: Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional
timeFrame: Baseline, Week 16
measure: Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work
timeFrame: Baseline, Week 16
measure: Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status
timeFrame: Week 16
measure: Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours
timeFrame: Baseline, Week 16
measure: Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours
timeFrame: Baseline, Week 16
measure: Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work
timeFrame: Baseline, Week 16
measure: Family Dermatology Life Quality Index (FDLQI) Score
timeFrame: Baseline, Week 16, 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Group
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: Expresscare Medical (X-Rays only)
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Torrance
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, PC
state: Georgia
city: Algonquin
country: United States
facility: Sherman Immediate Care Center (Imaging Only)
state: Illinois
city: Schaumburg
country: United States
facility: Schaumburg Dermatology
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Division of Dermatology
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre - Dermcenter
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota - Department of Dermatology
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University - Department of Dermatology
state: Missouri
city: St. Louis
country: United States
facility: Central Dermatology, PC
state: Missouri
city: Henderson
country: United States
facility: Bettencourt Skin Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center - Section of Dermatology
state: New Hampshire
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: New York
country: United States
facility: The Rockefeller University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Austin
country: United States
facility: Austin Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center, PA
state: Texas
city: Dallas
country: United States
facility: InSight Diagnostic Center
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Office of Mark S. Lee, MD
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Calgary
country: Canada
facility: Northwest Dermatology & Laser Centre
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Surrey
country: Canada
facility: Guildford Dermatology Specialists
state: British Columbia
city: Victoria
country: Canada
facility: Practice office of John D. Amiss MD
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd
state: British Columbia
city: St. John's
country: Canada
facility: NewLab Clinical Research Inc.
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates Ltd.
state: Nova Scotia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
state: Ontario
city: Courtice
country: Canada
facility: Co-Medica Research Network Inc.
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Oshawa
country: Canada
facility: Oshawa Clinic
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc.
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Berlin
country: Germany
facility: Facharzt fuer Dermatologie und Allergologie
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Buch GmbH
city: Buchholz
country: Germany
facility: Dres.Kirsten Prepeneit und Volker Streit
city: Frankfurt/Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universitaet
city: Halle
country: Germany
facility: Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hanau
country: Germany
facility: Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
city: Luebeck
country: Germany
facility: Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie
city: Mahlow
country: Germany
facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling
city: Wiesbaden/ Bierstadt
country: Germany
facility: Wilhelm Fresenius Klinik
city: Witten
country: Germany
facility: Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin
city: Szekszard
country: Hungary
facility: Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat
city: Mexico
country: Mexico
facility: Instituto Mexicano de Investigacion Clinica, S.A. de C.V
state: D.f.
city: Zapopan
country: Mexico
facility: Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
state: Jalisco
city: Monterrey
country: Mexico
facility: Centro Medico San Lucas
state: Nuevo Leon
city: Lodz
country: Poland
facility: Specjalistyczne Gabinety Lekarskie "Dermed�
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warszawa
country: Poland
facility: Klinika Dermatologii Wojskowy Instytut Medyczny
city: Carolina
country: Puerto Rico
facility: The Office of Dr. Alma M. Cruz, MD.
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Niao-Sung Hsiang
country: Taiwan
facility: Chang Gung Memorial Hospital Kaohsiung branch
state: Kaohsiung County
city: Kwei-Shan
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou Branch
state: Taoyuan
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Kharkiv
country: Ukraine
facility: MIHC Kharkiv City Dermatovenerologic Dispensary #2
city: Kyiv
country: Ukraine
facility: Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
city: Lugansk
country: Ukraine
facility: Lugansk Regional Dermatovenerologic Dispensary
city: Lviv
country: Ukraine
facility: Lviv regional municipal dermatovenerologic dispensary,
city: Odessa
country: Ukraine
facility: Department of dermatology and venereology of Odessa National Medical University
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
citation: Merola JF, Elewski B, Tatulych S, Lan S, Tallman A, Kaur M. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017 Jul;77(1):79-87.e1. doi: 10.1016/j.jaad.2017.01.053. Epub 2017 Apr 7.
citation: Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, Langley R, Luger T, Thaci D, Buonanno M, Gupta P, Proulx J, Lan S, Wolk R; OPT Pivotal 1 and OPT Pivotal 2 investigators. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61. doi: 10.1111/bjd.14018.