A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01519089
First received: December 22, 2011
Last updated: February 13, 2014
Last verified: February 2014

December 22, 2011
February 13, 2014
March 2012
January 2014   (final data collection date for primary outcome measure)
  • Incidence of adverse events, clinical laboratory abnormalities, vital sign abnormalities and electrocardiogram (ECG) abnormalities [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Change from baseline in clinical laboratory values, vital sign measures and ECG measurements. [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Number of subjects with pre-specified cardiovascular events [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Number of subjects with malignancies confirmed by central laboratory pathologist over-read [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with a Psoriasis Area and Severity Index 75 (PASI75) response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects With an American College of Rheumatology 20% (ACR20) Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01519089 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with a Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with a Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with a Psoriasis Area and Severity Index 90 (PASI90) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Time to achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • Time to Achieve a PASI75 Response [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • Time to Achieve a PASI50 Response [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects with PASI score >= 125 percent of the baseline PASI scor [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index (PASI) scores [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index (PASI) component scores [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with categorical responses in Physician Global Assessment (PGA) of psoriasis score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Number of subjects maintaining PASI75 response [ Time Frame: Week 16 up to Week 52 ] [ Designated as safety issue: No ]
  • Number of subjects maintaining PGA response [ Time Frame: Week 16 up to Week 52 ] [ Designated as safety issue: No ]
  • Nail Psoriasis Severity Index (NAPSI) [ Time Frame: Week 8, 16, 20, 28, 40 and 52 ] [ Designated as safety issue: No ]
  • Number of affected nails [ Time Frame: Week 8, 16, 20, 28, 40 and 52 ] [ Designated as safety issue: No ]
  • Itch Severity Item (ISI) score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index (DLQI) score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 ] [ Designated as safety issue: No ]
  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Week 16, 28 and 52 ] [ Designated as safety issue: No ]
  • Work Limitation Questionnaire (WLQ) [ Time Frame: Week 4, 16, 28 and 52 ] [ Designated as safety issue: No ]
  • Patient Global Assessment (PtGA) of Psoriasis Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 ] [ Designated as safety issue: No ]
  • Joint Pain Assessment (JPA) [ Time Frame: Week 4, 16, 28 and 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects with an American College of Rheumatology 20% (ACR20) response [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with an American College of Rheumatology 50% (ACR50) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with an American College of Rheumatology 70% (ACR70) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Change from baseline in American College of Rheumatology (ACR) components [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: CP-690,550
    10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
  • Drug: CP-690, 550
    5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
  • Experimental: CP-690,550 10 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP690,550 5 mg BID
    Intervention: Drug: CP-690, 550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01519089
A3921137
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP