Raptiva in Palm and Sole Psoriasis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date of first subject’s first visit: 29 Sep 2008 Date of last subject’s last visit: 25 May 2009 Subjects were screened at 3 centers in Australia, of which 2 centers enrolled subjects. It was planned to conduct the trial in centers in Australia and Latin America; however, the trial was terminated before most centers were initiated.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening was performed within 2 weeks prior to starting trial treatment.

Reporting Groups

	Description
Raptiva	Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
Placebo	Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks

Participant Flow:   Overall Study

	Raptiva	Placebo
STARTED	5	1
COMPLETED	0	0
NOT COMPLETED	5	1
Adverse Event	1	0
Early study termination by sponsor	4	1

Reporting Groups

	Description
Raptiva	Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
Placebo	Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
Total	Total of all reporting groups

Baseline Measures

	Raptiva	Placebo	Total
Number of Participants   [units: participants]	5	1	6
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	5	1	6
>=65 years	0	0	0
Gender   [units: participants]
Female	2	0	2
Male	3	1	4
Region of Enrollment   [units: participants]
Australia	5	1	6
Negative Serum Pregnancy Test [1] [units: participants]
Negative test	1	0	1
Not tested (Male or surgically sterile female)	4	1	5
Negative Urinary Pregnancy Test [2] [units: participants]
Negative test	1	0	1
Not tested (Male or surgically sterile female)	4	1	5

1.  Primary:

Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)   [ Time Frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

2.  Primary:

Static Physician Global Assessment Hands and Feet (sPGA – H&F)   [ Time Frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit ]

3.  Primary:

Psoriasis Area and Severity Index (PASI)   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

4.  Primary:

Static Physician Global Assessment (SPGA)   [ Time Frame: Measured at Screening, Day 0 and Day 7 ]

5.  Primary:

Dynamic Physician's Global Assessment of Change (dPGA)   [ Time Frame: Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

6.  Secondary:

Participants With Direct Physical Examination Abnormalities   [ Time Frame: Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits ]

7.  Secondary:

Complaint Directed Physical Examinations   [ Time Frame: Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits) ]

8.  Secondary:

Heart Rate   [ Time Frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits ]

9.  Secondary:

Arterial Blood Pressure   [ Time Frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits ]

10.  Secondary:

Temperature   [ Time Frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits ]

11.  Secondary:

Weight Measurements   [ Time Frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

12.  Secondary:

Haematology Laboratory Assessments - Haemoglobin   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

13.  Secondary:

Haematology Laboratory Assessments - Haematocrit   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

14.  Secondary:

Haematology Laboratory Assessments - Red Cell Count   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

15.  Secondary:

Haematology Laboratory Assessments - White Cell Count   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

16.  Secondary:

Haematology Laboratory Assessments - Platelets   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

17.  Secondary:

Haematology Laboratory Assessments - Neutrophils   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

18.  Secondary:

Haematology Laboratory Assessments - Lymphocytes   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

19.  Secondary:

Haematology Laboratory Assessments - Monocytes   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

20.  Secondary:

Haematology Laboratory Assessments - Eosinophils   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

21.  Secondary:

Haematology Laboratory Assessments - Basophils   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

22.  Secondary:

Clinical Chemistry Laboratory Assessments - Sodium   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

23.  Secondary:

Clinical Chemistry Laboratory Assessments - Potassium   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

24.  Secondary:

Clinical Chemistry Laboratory Assessments - Urea   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

25.  Secondary:

Clinical Chemistry Laboratory Assessments - Creatinine   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

26.  Secondary:

Clinical Chemistry Laboratory Assessments - Total Bilirubin   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

27.  Secondary:

Clinical Chemistry Laboratory Assessments - Total Protein   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

28.  Secondary:

Clinical Chemistry Laboratory Assessments - Calcium   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

29.  Secondary:

Clinical Chemistry Laboratory Assessments - Aspartate Transaminase   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

30.  Secondary:

Clinical Chemistry Laboratory Assessments - Alanine Transaminase   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

31.  Secondary:

Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

32.  Secondary:

Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

33.  Secondary:

Clinical Chemistry Laboratory Assessments - C Reactive Protein   [ Time Frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits ]

34.  Secondary:

Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test   [ Time Frame: Measured at screening (Day -14 to Day -1) ]

35.  Secondary:

Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test   [ Time Frame: Measured at screening (Day -14 to Day -1) ]