A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01276639
• Date of registration: 12/01/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
• Scientific 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
• Date of first enrolment: March 2011
• Target sample size: 901
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01276639
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, Colombia, Germany, Hungary, Japan, Mexico, Poland, Serbia, Taiwan, Ukraine, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis

Intervention(s)

Drug: CP-690,550

Drug: Placebo/CP-690,550

Primary Outcome(s)

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 [Time Frame: Week 16]

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 [Time Frame: Week 16]

Secondary Outcome(s)

Dermatology Life Quality Index (DLQI) Score [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Dermatology Life Quality Index (DLQI) Total Score [Time Frame: Baseline]

Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52 [Time Frame: Week 52]

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work [Time Frame: Baseline, Week 16]

Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 [Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52]

Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52 [Time Frame: Week 52]

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16 [Time Frame: Week 16]

Psoriasis Area and Severity Index (PASI) Component Scores [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours [Time Frame: Baseline, Week 16]

Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response [Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) [Time Frame: Baseline, Week 16, 28, 40, 52]

Family Dermatology Life Quality Index (FDLQI) Score [Time Frame: Baseline, Week 16, 52]

36-Item Short-Form Health Survey Version 2, Acute (SF-36) [Time Frame: Baseline, Week 16, 28, 52]

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 [Time Frame: Week 4, 16]

Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response [Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Number of Affected Nails [Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52]

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4 [Time Frame: Week 4]

Psoriasis Area and Severity Index (PASI) Score [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Total Body Surface Area (BSA) With Psoriasis [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Nail Psoriasis Severity Index (NAPSI) Score [Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52]

Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response [Time Frame: Week 16, 28, 52]

Itch Severity Item (ISI) Score [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4 [Time Frame: Week 4]

Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response [Time Frame: Week 8, 16, 20, 28, 40, 52]

Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score [Time Frame: Baseline, Week 16, 28, 40, 52]

Percentage of Participants With Patient Global Assessment (PtGA) Scale Response [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Work Limitation Questionnaire (WLQ) Index Score [Time Frame: Baseline, Week 4, 16, 28, 52]

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status [Time Frame: Week 16]

Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score [Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 [Time Frame: Baseline, Week 16]

Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 [Time Frame: Baseline, Week 8, 16, 20, 28, 40, 52]

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work [Time Frame: Baseline, Week 16]

Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [Time Frame: Baseline up to Week 16]

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional [Time Frame: Baseline, Week 16]

Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 [Time Frame: Baseline, Week 16]

Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours [Time Frame: Baseline, Week 16]

Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52 [Time Frame: Week 52]

Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response [Time Frame: Week 8, 16, 20, 28, 40, 52]

Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response [Time Frame: Baseline up to Week 16]

Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response [Time Frame: Baseline up to Week 16]

Hospital Anxiety and Depression Scale (HADS) Score [Time Frame: Baseline, Week 4, 16, 28, 52]

Joint Pain Assessment (JPA) Score [Time Frame: Baseline, Week 4, 16, 28, 52]

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response [Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score [Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52]

Secondary ID(s)

A3921078

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/09/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01276639