A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis - Full Text View

Purpose

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

Condition	Intervention	Phase
Psoriasis	Drug: CP 690,550 5 mg Drug: CP 690,550 10 mg Biological: Etanercept 50 mg Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Physician's Global Assessment (PGA)response ie, the proportion of participants achieving a PGA of "clear" or "almost clear" at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Psoriasis Area and Severity Index 75 (PASI75) response ie, the proportion of participants achieving at least a 75% reduction in Psoriasis Area and Severity Index relative to baseline at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physicians Global Assessment (PGA)response [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Proportion of participants in each Physicians Global Assessment (PGA) category [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Actual and change from baseline in Psoriasis Area And Severity Index (PASI) component scores [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Percent change from baseline in Psoriasis Area And Severity Index (PASI) [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Actual and percent change from baseline in Body Surface Area (BSA) [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Proportion of participants achieving at least a 50% and 90% reduction in PASI relative to baseline (PASI50 and PASI90, respectively) [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Time to Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Time to Psoriasis Area and Severity Index 75 (PASI75) responses [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Proportion of participants with a PASI score of >=125% of the baseline PASI [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Actual and change from baseline in the Itch Severity Item (ISI) score [ Time Frame: Baseline, Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Actual and change from baseline in the Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline, Weeks 4,12 ] [ Designated as safety issue: No ]
Short Form-36 (SF-36) - Version 2, Acute [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Patient Global Assessment of Psoriasis score (PtGA) [ Time Frame: Weeks 2,4,8,12 ] [ Designated as safety issue: No ]
Patient Satisfaction with Study Medication (PSSM) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Dimension Health State EuroQol (EQ-5D) score at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Psoriasis Health Care Resource Utilization Questionnaire (Ps-HCRU) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Psoriasis Quality of Life score (PQOL-12) at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment:	1108
Study Start Date:	November 2010
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CP 690,550 5 mg BID+Placebo BIW	Drug: CP 690,550 5 mg CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Experimental: CP 690,550 10 mg BID+Placebo BIW	Drug: CP 690,550 10 mg CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
Active Comparator: Placebo BID+Etanercept 50 mg BIW	Biological: Etanercept 50 mg Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks
Placebo Comparator: Placebo BID+Placebo BIW	Other: Placebo Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
Have plaque-type psoriasis covering at least 10% of total body surface area
Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria:

Non-plaque or drug induced forms of psoriasis
Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
Cannot discontinue phototherapy
Any uncontrolled significant medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241591

Show 122 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01241591 History of Changes
Other Study ID Numbers:	A3921080
Study First Received:	November 12, 2010
Last Updated:	February 26, 2013
Health Authority:	European Union: European Medicines Agency

Keywords provided by Pfizer:

CP-690,550
Etanercept
Moderate
Severe
Chronic

Plaque
Psoriasis
Efficacy
Safety

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013