Clinical Trials/NCT01519089

NCT01519089

Completed

Phase 3

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

Pfizer16 sites in 1 country95 target enrollmentMarch 2012

ConditionsPsoriasis

InterventionsCP-690,550 CP-690, 550

DrugsCP-690,550 CP-690, 550

Overview

Phase: Phase 3
Intervention: CP-690,550
Conditions: Psoriasis
Sponsor: Pfizer
Enrollment: 95
Locations: 16
Primary Endpoint: Number of Participants With Adjudicated Cardiovacular Events
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

January 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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

Arms & Interventions

CP-690,550 10 mg BID

Intervention: CP-690,550

CP690,550 5 mg BID

Intervention: CP-690, 550

Outcomes

Primary Outcomes

Number of Participants With Adjudicated Cardiovacular Events

Time Frame: Baseline to Follow-up

Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16

Time Frame: Week 16

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.

Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16

Time Frame: Week 16

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16

Time Frame: Week 16

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Number of Participants With Malignancy Events _Week 0 Through Follow-up

Time Frame: Baseline to Follow-up

For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.

Secondary Outcomes

Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16(Week 20, 28, 40, 52)
Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'(Week 20, 28, 40, 52)
Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response(Week 16)
Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response(Week 16)
Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'(Week 16)
Number of Affected Nails(Baseline, Week 8, 16, 20, 28, 40, 52)
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response(Week 2, 4, 8, 12, 20, 28, 40, 52)
Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response(Week 16)
Itch Severity Item (ISI) Score(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Dermatology Life Quality Index (DLQI) Score(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'(Week 2, 4, 8, 12, 20, 28, 40, 52)
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score(Week 8, 16, 20, 28, 40, 52)
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score(Week (W) 16, 28, 52)
Joint Pain Assessment (JPA)(Baseline, Week 4, 16, 28, 52)
Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score(Week 16, 28, 52)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response(Week 2, 4, 8, 12, 20, 28, 40, 52)
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
Work Limitation Questionnaire (WLQ)(Baseline (BL), Week (W) 4, 16, 28, 52)