Trial Outcomes & Findings for Raptiva in Palm and Sole Psoriasis (NCT NCT00972543)
NCT ID: NCT00972543
Last Updated: 2014-02-13
Results Overview
Minimum possible score 0, maximum possible score 72.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Results posted on
2014-02-13
Participant Flow
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.
Screening was performed within 2 weeks prior to starting trial treatment.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Early study termination by sponsor
|
4
|
1
|
Baseline Characteristics
Raptiva in Palm and Sole Psoriasis
Baseline characteristics by cohort
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Negative Serum Pregnancy Test
Negative test
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Negative Serum Pregnancy Test
Not tested (Male or surgically sterile female)
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Negative Urinary Pregnancy Test
Negative test
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Negative Urinary Pregnancy Test
Not tested (Male or surgically sterile female)
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsPopulation: Results not analysed due to early termination of the study
Minimum possible score 0, maximum possible score 72.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination VisitPopulation: Results not analysed due to early termination of the study
Minimum possible score 0, maximum possible score 4.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsPopulation: Results not analysed due to early termination of the study
Minimum possible score 0, maximum possible score 72.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at Screening, Day 0 and Day 7Population: Results not analysed due to early termination of the study
The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsPopulation: Results not analysed due to early termination of the study
The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visitsPopulation: Results not analysed due to early termination of the study
Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)Population: Results not analysed due to early termination of the study
Number of participants undergoing complaint directed physical examinations
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visitsPopulation: Results not analysed due to early termination of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visitsPopulation: Results not analysed due to early termination of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visitsPopulation: Results not analysed due to early termination of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsPopulation: Results not analysed due to early termination of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Haemoglobin
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Haemoglobin
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Haematocrit
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Haematocrit
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Red Cell Count
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Red Cell Count
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - White Cell Count
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - White Cell Count
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Platelets
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Platelets
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Neutrophils
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Neutrophils
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Lymphocytes
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Lymphocytes
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Monocytes
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Monocytes
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Eosinophils
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Eosinophils
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Haematology Laboratory Assessments - Basophils
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Haematology Laboratory Assessments - Basophils
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Sodium
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Sodium
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Potassium
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
|
Clinical Chemistry Laboratory Assessments - Potassium
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Urea
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Urea
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Creatinine
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Creatinine
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Total Bilirubin
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Total Bilirubin
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Total Protein
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Total Protein
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Calcium
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Calcium
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Aspartate Transaminase
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Aspartate Transaminase
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Alanine Transaminase
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Alanine Transaminase
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visitsParticipants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Clinical Chemistry Laboratory Assessments - C Reactive Protein
Subjects without values reported as adverse events
|
5 participants
|
1 participants
|
|
Clinical Chemistry Laboratory Assessments - C Reactive Protein
Subjects with values reported as adverse events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at screening (Day -14 to Day -1)A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test
Negative test
|
1 participants
|
0 participants
|
|
Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test
Not tested (Male or surgically sterile female)
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Measured at screening (Day -14 to Day -1)A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.
Outcome measures
| Measure |
Raptiva
n=5 Participants
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
n=1 Participants
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
|
|---|---|---|
|
Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test
Negative test
|
1 participants
|
0 participants
|
|
Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test
Not tested (Male or surgically sterile female)
|
4 participants
|
1 participants
|
Adverse Events
Raptiva
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Raptiva
n=5 participants at risk
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
n=1 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Meningitis aseptic
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Infections and infestations
Osteomyelitis
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
Other adverse events
| Measure |
Raptiva
n=5 participants at risk
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
n=1 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Flu-like symptoms
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Psychiatric disorders
Anxiety attack
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 3 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Infections and infestations
Folliculitis of groin
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Intertrigo of groin
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Eye disorders
Left eye redness
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 6 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
General disorders
Generalized body ache
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
General disorders
Swelling of left heel
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Infections and infestations
Secondary infection, both feet
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis, both feet
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash on body (id reaction)
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Bilateral arm aches (nonspecific)
|
0.00%
0/5 • Up to 32 weeks
|
100.0%
1/1 • Number of events 1 • Up to 32 weeks
|
|
General disorders
Flu-like symptoms
|
0.00%
0/5 • Up to 32 weeks
|
100.0%
1/1 • Number of events 2 • Up to 32 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 3 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Infections and infestations
Infected right foot
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Widespread eczematous rash
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Infections and infestations
Ear infection
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Telogen effluvium
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Eczematous rash
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
|
Infections and infestations
Cellulitis right leg
|
20.0%
1/5 • Number of events 1 • Up to 32 weeks
|
0.00%
0/1 • Up to 32 weeks
|
Additional Information
Medical Responsible
Merck Serono S.A., a division of Merck KGaA
Phone: +49-6151-75-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER