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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01276639
First received: January 12, 2011
Last updated: February 3, 2014
Last verified: February 2014

January 12, 2011
February 3, 2014
March 2011
April 2013   (final data collection date for primary outcome measure)
  • Physician Global Assessment (PGA) response, ie, the proportion of participants achieving a PGA of "clear" or "almost clear" at week 16 [ Time Frame: Week 16 ] [ 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 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment (PGA) response, ie, the proportion of subjects achieving a PGA of "clear" or "almost clear", at Week 16. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) response, ie, the proportion of subjects achieving at least a 75% reduction in PASI relative to baseline at Week 16. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01276639 on ClinicalTrials.gov Archive Site
  • Change from baseline in Body Surface Area (BSA) at Week 16 [ Time Frame: baseline, Week 16 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 90 (PASI90) response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 [ Time Frame: baseline, Week 16 ] [ Designated as safety issue: No ]
  • Physician Global Assessment (PGA) response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index 75 (PASI75) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatology Life Quality Index (DLQI) total score at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) at week 16 in participants with nail psoriasis at baseline [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Physicians Global (PGA) response at week 52 among participants achieving PGA response at Week 16 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Psoriasis Area Severity Index 75 (PASI75) response at Week 52 among participants achieving PASI75 response at week 16 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of participants maintaining Psoriasis Area Index 90 (PASI90) response at week 52 among participants achieving PASI90 response at week 16 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to Physicians Global Assessment (PGA) response [ Time Frame: Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 75(PASI75) response [ Time Frame: Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Time to Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: Weeks 2,4,8,12,16 ] [ Designated as safety issue: No ]
  • Physicians Global Assessment (PGA)response [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants in each Physicians Global Assessment (PGA) category [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Psoriasis Aera and Severity Index 75 (PASI75) response [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in Psoriasis Area and Severity Index (PASI) and component scores [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Physicians Area and Severity Index (PASI) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and percent change from baseline in Body Surface Area (BSA) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ 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 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants with a PASI score > or equal to 125% of the baseline PASI score at any time point through Week 52 [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline Nail Psoriasis Severity Index (NAPSI) and number of affected nails in participants with nail psoriasis at baseline [ Time Frame: Baseline, Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Nail Psoriasis Severity Index (NAPSI) in participants with nail psoriasis at baseline [ Time Frame: Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Proportion of participants achieving at least 75% and 100% reduction in Nail Psoriasis Severity Index (NAPSI) relative to baseline (NAPSI75 and NAPSI100, respectively) in subjects with nail psoriasis at baseline [ Time Frame: Weeks 8,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in Itch Severity Item (ISI) score [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Actual and change from baseline in the Dermatology Life Quality Index (DLQI) score [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 4,16,28,52 ] [ Designated as safety issue: No ]
  • Short Form 36 Health Survey (SF 36) - Version 2, Acute [ Time Frame: Weeks 16,28,52 ] [ Designated as safety issue: No ]
  • Work Limitation Questionnaire (WLQ) [ Time Frame: Weeks 4,16,28,52 ] [ Designated as safety issue: No ]
  • Patient Global Assessment (PtGA) [ Time Frame: Weeks 2,4,8,12,16,20,28,40,52 ] [ Designated as safety issue: No ]
  • Patient Satisfaction with Study Medication (PSSM) [ Time Frame: Weeks 16,28,52 ] [ Designated as safety issue: No ]
  • Joint Pain Assessment (JPA) [ Time Frame: Weeks 4,16,28,52 ] [ Designated as safety issue: No ]
  • Euro Qol 5 Dimensions (EQ-5D) [ Time Frame: Weeks 16,28,40,52 ] [ Designated as safety issue: No ]
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) [ Time Frame: Weeks 16,28,40,52 ] [ Designated as safety issue: No ]
  • Family Dermatology Life Quality Index (FDLQI) [ Time Frame: Weeks 16,52 ] [ Designated as safety issue: No ]
  • PASI50 response at Week 2, PGA response at Week 4, PASI75 response at Week 4. [ Time Frame: Weeks 2, 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Itch Severity Item (ISI) score at Week 16. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in DLQI total score at Week 4, Change from baseline in Dermatology Life Quality Index (DLQI) total score at Week 16. [ Time Frame: Weeks 4, 16 ] [ Designated as safety issue: No ]
  • Change from baseline in ISI score at Week 2. [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Time to PGA response up to Week 16, Time to PASI75 response up to Week 16, Time to PASI50 response up to Week 16. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • PGA response at various time points through Week 52, Proportion of subjects in each PGA category at various time points through Week 52, PASI75 response at various time points through Week 52. [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
  • Maintenance of PGA and PASI75 responses between Week 16 and Week 52 among the PGA or PASI75 responders at Week 16 who were treated with tasocitinib (CP 690,550). [ Time Frame: Week 16 through Week 52 ] [ Designated as safety issue: No ]
  • The actual and change from baseline in PASI and PASI component scores at various time points through Week 52. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving at least a 50% and 90% reduction in PASI relative to baseline (PASI50 and PASI90, respectively) at various time points through Week 52. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a PASI score 125% of the baseline PASI score at any time point through Week 52. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: No ]
  • The actual and change from baseline in Nail Psoriasis Severity Index (NAPSI) and number of affected nails at various time points through Week 52. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: No ]
  • The actual and change from baseline in the Itch Severity Item (ISI) score at various time points through Week 52. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: No ]
  • The actual and change from baseline on the Dermatology Life Quality Index (DLQI) score at various time points through Week 52. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: No ]
  • Other patient reported outcome (PRO) measures to be assessed at various time points through Week 52. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events, clinical laboratory abnormalities, clinically significant chagnes in physical examination form baseline, vital sign abnormalities, electrocardiogram (ECG) abnormalities over 52 weeks. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: Yes ]
  • Summary of adjudicated cardiovascular endpoints and central laboratory pathologist over read of malignancy events. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: Yes ]
  • Oral clearance (CL/F) and other PK parameters calculated from plasma CP-690,550 concentrations. [ Time Frame: Various time points through Week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
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

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

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 oral BID, Continuous treatment for 52 Weeks
  • Drug: CP-690,550
    5 mg oral BID, Continuous treatment for 52 Weeks
  • Drug: Placebo/CP-690,550
    0 mg oral BID, Continuous treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
  • Drug: Placebo/CP-690,550
    0 mg oral BID, Continuous treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
  • Experimental: Active Treatment 10 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: ActiveTreatment 5 mg BID
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo Treatment
    Interventions:
    • Drug: Placebo/CP-690,550
    • Drug: Placebo/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
905
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Colombia,   Germany,   Hungary,   Japan,   Mexico,   Poland,   Serbia,   Taiwan,   Ukraine
 
NCT01276639
A3921078
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