Clinical trial NCT01276639: A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
Official title: Phase 3 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
chronic
Pruritus
Itch
DLQI
severe
moderate
treatment
safety
efficacy
CP-690,550
Plaque Psoriasis
Psoriasis Vulgaris
Jax-inhibitor
Oral Treatment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 901
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:

* Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
* a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
* 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: 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 a 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, 12, 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 4, 16, 28, 52
measure: Work Limitation Questionnaire (WLQ) Index Score
timeFrame: Baseline, Week 4, 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 4, 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: Radiant Research, Inc.
state: Alabama
city: Irvine
country: United States
facility: University of California, Irvine - Dermatology Research
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc.
state: Colorado
city: New Haven
country: United States
facility: The Savin Center, P.C.
state: Connecticut
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Academic Alliance in Dermatology
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, P.C.
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Dermatology Associates Research Center
state: Georgia
city: Newnan
country: United States
facility: MedaPhase Inc.
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
state: Massachusetts
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Raleigh
country: United States
facility: Raleigh Radiology Blue Ridge
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Lake Oswego
country: United States
facility: Baker Allergy, Asthma and Dermatology Research Center, LLC
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Department of Dermatology
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville, PC
state: Tennessee
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Spokane
country: United States
facility: Rockwood Dermatology Center
state: Washington
city: Spokane
country: United States
facility: Rockwood Research Center
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center - Clinical Research Department
state: Washington
city: Madison
country: United States
facility: Madison Skin and Research, Inc.
state: Wisconsin
city: Winnipeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: St. John's
country: Canada
facility: Dr. Zohair Tomi PMC Inc.
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates Ltd.
state: Nova Scotia
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Oakville
country: Canada
facility: Oakville Dermatology Laser Centre
state: Ontario
city: Ottawa
country: Canada
facility: Office of Dr. Michael Robern
state: Ontario
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc.
state: Ontario
city: Quebec
country: Canada
facility: CRCMRGilbert Inc., Centre de Dermatologie Maizerets
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y Ortopedia
state: Atlantico
city: Bogot
country: Colombia
facility: Riesgo de Fractura S.A
state: Cundinamarca
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Aerztehaus "Rudolf Virchow"
city: Bonn
country: Germany
facility: Klinik und Poliklinik fuer Dermatologie und Allergologie der Universitaet Bonn
city: Dresden
country: Germany
facility: Universitaetsklinik Carl Gustav Carus
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Vechta
country: Germany
facility: Praxisklinik fuer Dermatologie, Allergologie und Venenheilkunde
city: Wuppertal
country: Germany
facility: Facharzt fuer Dermatologie und Venerologie, Allergologie
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktatokorhaz, Borgyogyaszat
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem/Bor-, Nemikortani es Onkodermatologiai Klinika
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Sapporo
country: Japan
facility: JR Sapporo hospital
state: Hokkaido
city: Chuo-ku
country: Japan
facility: Kobe University Hospital
state: Kobe
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Shinjyuku-ku
country: Japan
facility: Social Insurance Chuo General Hospital
state: Tokyo
city: Monterrey
country: Mexico
facility: Centro de Dermatologia de Monterrey
state: Nuevo Leon
city: Poznan
country: Poland
facility: Poznanski Osrodek Medyczny
city: Szczecin
country: Poland
facility: Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
city: Wroclaw
country: Poland
facility: Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
city: Wroclaw
country: Poland
facility: Oddzial Dermatologiczny
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Simferopol
country: Ukraine
facility: Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I. Georgiyevskyj"
state: Crimea
city: Kharkiv
country: Ukraine
facility: Dept of Dermatology, Infectious and Parasitic Skin Diseases
city: Kyiv
country: Ukraine
facility: Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
city: Ternopil
country: Ukraine
facility: Ternopil Regional Clinical Dermatovenerologic Dispensary
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: Wolk R, Armstrong EJ, Hansen PR, Thiers B, Lan S, Tallman AM, Kaur M, Tatulych S. Effect of tofacitinib on lipid levels and lipid-related parameters in patients with moderate to severe psoriasis. J Clin Lipidol. 2017 Sep-Oct;11(5):1243-1256. doi: 10.1016/j.jacl.2017.06.012. Epub 2017 Jun 24.
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: Tan H, Valdez H, Griffins CE, Mrowietz U, Tallman A, Wolk R, Gordon K. Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2017 Feb;28(1):3-7. doi: 10.1080/09546634.2016.1214671. Epub 2016 Aug 18.
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.