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A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis


Phase 3
18 Years
N/A
Not Enrolling
Both
Psoriasis

Thank you

Trial Information

A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis


Inclusion Criteria:



- 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at
least 12 months prior to first dose of study drug;

- Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's
Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at
least 10% of body surface area;

- No evidence of active or latent or inadequately treated infection with Tuberculosis
or other serious infections.

Exclusion Criteria:

- Non-plaque or drug induced forms of psoriasis;

- Cannot discontinue current oral, injectable or topical therapy for psoriasis or
cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).

- Any uncontrolled significant medical condition.

Type of Study:

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

Outcome Measure:

Proportion of participants maintaining a PASI75 response (at least a 75% reduction PASI relative to baseline) during the 16 week double blind active or placebo treatment period (CP- 690,550 treatment withdrawal; Period B)

Outcome Time Frame:

Weeks 28,32,36,40

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3921111

NCT ID:

NCT01186744

Start Date:

September 2010

Completion Date:

January 2013

Related Keywords:

  • Psoriasis
  • chronic
  • moderate
  • severe
  • treatment
  • safety
  • treatment withdrawal
  • retreatment
  • CP-690
  • 550
  • Psoriasis Vulgaris
  • Plaque Psoriasis
  • Psoriasis

Name

Location

Rhode Island HospitalProvidence, Rhode Island  02903
Duke University Medical CenterDurham, North Carolina  27710
University of California San FranciscoSan Francisco, California  941104206
Jewish HospitalCincinnati, Ohio  45236
Springfield Clinic, LLPSpringfield, Illinois  62703
Minnesota Clinical Study CenterFridley, Minnesota  55432
Center For Clinical StudiesHouston, Texas  77030
Associates In Research, Inc.Fresno, California  93720
New England Research Associates, LlcTrumbull, Connecticut  06611
Altman Dermatology AssociatesArlington Heights, Illinois  60004
University Hospitals Case Medical CenterCleveland, Ohio  44106
Miami Research AssociatesMiami, Florida  33173
Park Avenue Dermatology, PA1543 Kingsley Ave, Bldg 1 and 16 Orange Park, Florida  32073
Comprehensive Clinical ResearchBerlin, New Jersey  08009
Springfield ClinicSpringfield, Illinois  62703
Dermatology Research AssociatesLos Angeles, California  90045
Piedmont Medical ResearchWinston-Salem, North Carolina  27103
Horizon Research Group, Inc.Mobile, Alabama  36608
Dermatology Research AssociatesNashville, Tennessee  37203
International Dermatology Research, Inc.Miami, Florida  
Dermatology Consulting ServicesHigh Point, North Carolina  
Oregon Medical Research Center, PCPortland, Oregon  97223
Deaconess Clinic DowntownEvansville, Indiana  47713
Ameriderm ResearchJacksonville, Florida  32216
Radiant Research, Inc.Greer, South Carolina  29651
Florida Academic Dermatology CenterMiami, Florida  33136
DermResearch, PLLCLouisville, Kentucky  40217
Radiant Research, Inc.Chandler, Arizona  85225
Radiant Research, Inc.Akron, Ohio  44311
Dermatology Specialists, Inc.Oceanside, California  92056
Expresscare MedicalLos Angeles, California  90045
DMIALouisville, Kentucky  40207
Quest DiagnosticsLouisville, Kentucky  40217
Michigan Center for Research Corporation dba Michigan Center for Skin Care ResearchClinton Township, Michigan  48038
Dermatology AssociatesWilmington, North Carolina  28401
New Hanover Medical ResearchWilmington, North Carolina  28401
Triad Dermatology, PAWinston-Salem, North Carolina  27103
Piedmont ImagingWinston-Salem, North Carolina  27103
Office of Stephen Miller, MD, PASan Antonio, Texas  78229
Mountain State Clinical ResearchClarksburg, West Virginia  26301
Center for Dermatology Clinical Research, Inc.Fremont, California  94538
Longmont Clinic, PCLongmont, Colorado  80501
Northeast Dermatology AssociatesBeverly, Massachusetts  01915
ActivMed Practices and Research, Inc.Haverhill, Massachusetts  01830
PMG Research of Wilmington LLCWilmington, North Carolina  28401
New Hanover Medical Group, PAWilmington, North Carolina  28401
Medical Research South, LLCCharleston, South Carolina  29407
Dermatology & Laser Center of CharlestonCharleston, South Carolina  29414
Office of Marta T. Hampton, MDCharleston, South Carolina  29407
Office of John Michael Humeniuk, MDGreer, South Carolina  29650