Clinical trial NCT01519089: A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
Official title: A Phase 3, Multi Site, Randomized, Double Blind Study Of The Long-term Safety, Tolerability And Efficacy Of 2 Oral Doses Of Cp 690,550 In Subjects With Moderate To Severe Plaque Psoriasis And/or Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: chronic
severe
moderate
treatment
safety
efficacy
CP-690
550
Plaque psoriasis
Psoriasis Vulgaris
Psoriatic Arthritis
tofacitinib
Xeljanz
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 95
Sex: ALL
Minimum age (years): 20
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 evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Are 20 years or older and considered to be candidates for systemic or phototherapy.

\[Moderate to Severe Plaque Psoriasis\]

* Diagnosed for at least 12 months.
* Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA).

\[Psoriatic Arthritis\]

* Diagnosed for at least 6 months.
* Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening;
* Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter.

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16
timeFrame: Week 16
measure: Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
timeFrame: Week 16
measure: Number of Participants With Adjudicated Cardiovacular Events
timeFrame: Baseline to Follow-up
measure: Number of Participants With Malignancy Events _Week 0 Through Follow-up
timeFrame: Baseline to Follow-up
Secondary outcomes:
measure: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response
timeFrame: Week 2, 4, 8, 12, 20, 28, 40, 52
measure: Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
timeFrame: Week 16
measure: Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response
timeFrame: Week 16
measure: Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response
timeFrame: Week 16
measure: Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response
timeFrame: Week 16
measure: Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
timeFrame: Week 2, 4, 8, 12, 20, 28, 40, 52
measure: Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16
timeFrame: Week 20, 28, 40, 52
measure: Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'
timeFrame: Week 20, 28, 40, 52
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
timeFrame: Week 8, 16, 20, 28, 40, 52
measure: Number of Affected Nails
timeFrame: Baseline, 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: Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score
timeFrame: Week (W) 16, 28, 52
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score
timeFrame: Week 16, 28, 52
measure: Work Limitation Questionnaire (WLQ)
timeFrame: Baseline (BL), Week (W) 4, 16, 28, 52
measure: Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Joint Pain Assessment (JPA)
timeFrame: Baseline, Week 4, 16, 28, 52
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: Week 2, 4, 8, 12, 20, 28, 40, 52
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
measure: Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: JR Sapporo hospital
state: Hokkaido
city: Chuo-ku, Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital
state: Miyazaki
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Tokyo Teishin Hospital
state: Tokyo
city: Hachioji
country: Japan
facility: Tokyo medical university Hachioji medical center
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Kanto Medical Center NTT East Corporation
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Tonami
country: Japan
facility: Tonami General Hospital
state: Toyama
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Osaka
country: Japan
facility: Nissay Hospital
city: Tokyo
country: Japan
facility: Jikei University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: