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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


Phase 3
20 Years
N/A
Open (Enrolling)
Both
Psoriasis, Arthritis, Psoriatic

Thank you

Trial Information

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


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.

- 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

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:

Incidence of adverse events, clinical laboratory abnormalities, vital sign abnormalities and electrocardiogram (ECG) abnormalities

Outcome Time Frame:

Up to Week 52

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

A3921137

NCT ID:

NCT01519089

Start Date:

March 2012

Completion Date:

January 2014

Related Keywords:

  • Psoriasis
  • Arthritis, Psoriatic
  • chronic
  • severe
  • moderate
  • treatment
  • safety
  • efficacy
  • CP-690
  • 550
  • Plaque psoriasis
  • Psoriasis Vulgaris
  • Psoriatic Arthritis
  • Arthritis
  • Arthritis, Psoriatic
  • Psoriasis

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