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Long-term safety of tofacitinib in chronic plaque psoriasis
NCT01163253Phase 3
Key facts
- Status
- Terminated
- Start
- Sep 2010
- Primary completion
- Jun 2016
- Countries
- 36
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Conditions
- plaque psoriasis
01
Overview
Phase 3, open-label, single-arm trial of tofacitinib oral solution in plaque psoriasis, sponsored by Pfizer. Primary endpoints: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 67 months, Number of Adverse Events (AEs) by Severity up to 67 months and 13 more. Started Sep 2010; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Active Treatment
Tofacitinib 10 mg BID initially, then 5 or 10 mg BID
03
Who it enrols
Adult patients with moderate to severe chronic plaque psoriasis who participated in a qualifying study with CP-690,550.
04
Endpoints
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Adverse Events (AEs) by Severity
Number of Participants With Laboratory Abnormalities
Change From Baseline in Hemoglobin Level
Change From Baseline in Lymphocyte and Neutrophil Count
Secondary
Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'
Percentage of Participants Achieving Greater Than or Equal to 75 Percent Reduction From Baseline in PASI Scores
Psoriasis Area and Severity Index (PASI) Scores
PASI Component Scores: Erythema, Induration, Scaling
Percentage of Participants Achieving Greater Than or Equal to 50 Percent Reduction From Baseline in PASI Scores
Percentage of Participants Achieving Greater Than or Equal to 90 Percent Reduction From Baseline in PASI Scores
Percentage of Participants Achieving Greater Than or Equal to 125 Percent Increase From Baseline in PASI Scores
Itch Severity Item (ISI) Scores
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