Trial Outcomes & Findings for ChangE From Any Systemic psoriasiS therapY to Raptiva (NCT NCT00697593)
NCT ID: NCT00697593
Last Updated: 2014-02-13
Results Overview
Blood samples were taken for clinical laboratory testing
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
Week 12 / Early Termination
Results posted on
2014-02-13
Participant Flow
Date of first subject first visit: 22 January 2008 Date of last subject last visit: 21 April 2009 Subjects were enrolled at 13 study centers in 2 countries, including 10 study centers in Canada and 3 study centers in the Netherlands.
Subjects were to be screened for study eligibility within 14 days before Day 1
Participant milestones
| Measure |
Efalizumab
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Efalizumab
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Suspension of the study by sponsor
|
12
|
Baseline Characteristics
ChangE From Any Systemic psoriasiS therapY to Raptiva
Baseline characteristics by cohort
| Measure |
Efalizumab
n=70 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Age, Customized
18 - 40 years
|
26 participants
n=5 Participants
|
|
Age, Customized
41 to 64 years
|
36 participants
n=5 Participants
|
|
Age, Customized
>64 years
|
8 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
10 participants
n=5 Participants
|
|
static Physician's Global Assessment (sPGA)
Clear
|
0 participants
n=5 Participants
|
|
static Physician's Global Assessment (sPGA)
Minimal
|
4 participants
n=5 Participants
|
|
static Physician's Global Assessment (sPGA)
Mild
|
6 participants
n=5 Participants
|
|
static Physician's Global Assessment (sPGA)
Moderate
|
38 participants
n=5 Participants
|
|
static Physician's Global Assessment (sPGA)
Severe
|
21 participants
n=5 Participants
|
|
static Physician's Global Assessment (sPGA)
Very Severe
|
1 participants
n=5 Participants
|
|
Biochemistry - C-Reactive Protein (CRP)
Participants with <3 mg/L
|
36 participants
n=5 Participants
|
|
Biochemistry - C-Reactive Protein (CRP)
Participants with 3 mg/L-6mg/L
|
19 participants
n=5 Participants
|
|
Biochemistry - C-Reactive Protein (CRP)
Participants with >6 mg/L
|
15 participants
n=5 Participants
|
|
Biochemistry - Alanine Transaminase (ALT)
|
27.8 IU/L
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Biochemistry - Alkaline Phosphatase
|
76.6 IU/L
STANDARD_DEVIATION 19.0 • n=5 Participants
|
|
Biochemistry - Aspartate Transaminase (AST)
|
23.0 IU/L
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Biochemistry - Creatinine
|
82.9 μmol/L
STANDARD_DEVIATION 18.9 • n=5 Participants
|
|
Biochemistry - Glutamyl Transferase
|
25.9 IU/L
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Biochemistry - Potassium
|
4.19 mmol/L
STANDARD_DEVIATION 0.36 • n=5 Participants
|
|
Biochemistry - Values: Sodium
|
139.5 mmol/L
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Biochemistry - Total Bilirubin
|
8.0 μmol/L
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Biochemistry - Urea
|
5.677 mmol/L
STANDARD_DEVIATION 1.633 • n=5 Participants
|
|
Hematology - Hematocrit
|
0.430 packed cell volume
STANDARD_DEVIATION 0.040 • n=5 Participants
|
|
Hematology - Hemoglobin
|
145.0 g/L
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Hematology - Red Blood Cell Count
|
4.69 x10^12/L
STANDARD_DEVIATION 0.52 • n=5 Participants
|
|
Hematology - White Blood Cell Count
|
7.11 x10^9/L
STANDARD_DEVIATION 1.95 • n=5 Participants
|
|
Hematology - Basophils
|
0.032 x10^9/L
STANDARD_DEVIATION 0.033 • n=5 Participants
|
|
Hematology - Eosinophils
|
0.177 x10^9/L
STANDARD_DEVIATION 0.135 • n=5 Participants
|
|
Hematology - Lymphocytes
|
1.911 x10^9/L
STANDARD_DEVIATION 0.670 • n=5 Participants
|
|
Hematology - Monocytes
|
0.462 x10^9/L
STANDARD_DEVIATION 0.188 • n=5 Participants
|
|
Hematology - Neutrophils
|
4.533 x10^9/L
STANDARD_DEVIATION 1.582 • n=5 Participants
|
|
Hematology - Platelet Count
|
256.0 x10^9/L
STANDARD_DEVIATION 54.7 • n=5 Participants
|
|
Urinalysis - Glucose
Negative
|
66 participants
n=5 Participants
|
|
Urinalysis - Glucose
Present
|
4 participants
n=5 Participants
|
|
Urinalysis - Ketones
Negative
|
67 participants
n=5 Participants
|
|
Urinalysis - Ketones
Present
|
3 participants
n=5 Participants
|
|
Urinalysis - Values - Nitrite
Negative
|
69 participants
n=5 Participants
|
|
Urinalysis - Values - Nitrite
Positive
|
1 participants
n=5 Participants
|
|
Urinalysis - Leukocytes Esterase
Negative
|
60 participants
n=5 Participants
|
|
Urinalysis - Leukocytes Esterase
Present
|
10 participants
n=5 Participants
|
|
Urinalysis - Values - Protein
Negative
|
59 participants
n=5 Participants
|
|
Urinalysis - Values - Protein
Present
|
11 participants
n=5 Participants
|
|
Urinalysis - Blood
Negative
|
66 participants
n=5 Participants
|
|
Urinalysis - Blood
Present
|
4 participants
n=5 Participants
|
|
Urinalysis - pH
|
5.84 pH units
STANDARD_DEVIATION 0.49 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 4 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=66 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Hematocrit
|
0.434 packed cell volume
Standard Deviation 0.039
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Hemoglobin
|
144.8 g/L
Standard Deviation 13.0
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Red Blood Cell Count
|
4.78 x10^12/L
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - White Blood Cell Count
|
10.06 x10^9/L
Standard Deviation 2.69
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Neutrophils
|
5.047 x10^9/L
Standard Deviation 1.976
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Eosinophils
|
0.206 x10^9/L
Standard Deviation 0.130
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Basophils
|
0.050 x10^9/L
Standard Deviation 0.038
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Monocytes
|
0.526 x10^9/L
Standard Deviation 0.205
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Lymphocytes
|
4.209 x10^9/L
Standard Deviation 1.220
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 4 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=66 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Hematology - Platelet Count
|
255.5 x10^9/L
Standard Deviation 64.8
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Sodium
|
139.0 mmol/L
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Potassium
|
4.23 mmol/L
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Creatinine
|
83.1 μmol/L
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Total Bilirubin
|
7.2 μmol/L
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 2 participants missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=68 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Aspartate Transaminase (AST)
|
22.2 IU/L
Standard Deviation 9.6
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Alanine Transaminase (ALT)
|
28.7 IU/L
Standard Deviation 19.3
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Alkaline Phosphatase
|
80.2 IU/L
Standard Deviation 21.1
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Glutamyl Transferase
|
28.6 IU/L
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant missing values
Blood samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - Urea
|
5.283 mmol/L
Standard Deviation 1.628
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 1 participant with missing values
Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values \<3 mg/L, 3-6 mg/L, and \>6 mg/L
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Biochemistry - C-Reactive Protein (CRP)
participants with <3 mg/L
|
28 participants
|
|
Biochemistry - C-Reactive Protein (CRP)
participants with 3-6 mg/L
|
22 participants
|
|
Biochemistry - C-Reactive Protein (CRP)
participants with >6 mg/L
|
19 participants
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants missing values
Urine samples were taken for clinical laboratory testing
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Urinalysis - pH
|
5.75 pH units
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationUrine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Urinalysis - Protein
Negative
|
54 participants
|
|
Urinalysis - Protein
Present
|
13 participants
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationUrine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Urinalysis - Ketones
Negative
|
58 participants
|
|
Urinalysis - Ketones
Present
|
9 participants
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants with missing values
Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Urinalysis - Glucose
Negative
|
64 participants
|
|
Urinalysis - Glucose
Present
|
3 participants
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants with missing values
Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Urinalysis - Blood
Negative
|
58 participants
|
|
Urinalysis - Blood
Present
|
9 participants
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants with missing values
Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Urinalysis - Nitrite
Negative
|
65 participants
|
|
Urinalysis - Nitrite
Positive
|
2 participants
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationPopulation: Safety Population - 3 participants with missing values
Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine
Outcome measures
| Measure |
Efalizumab
n=67 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Urinalysis - Leukocytes Esterase
Negative
|
60 participants
|
|
Urinalysis - Leukocytes Esterase
Present
|
7 participants
|
PRIMARY outcome
Timeframe: Week 12 / Early TerminationInformation on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 Weeks/Early TerminationPopulation: Safety Population
Number of subjects who achieve an Static Physician's Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).
Outcome measures
| Measure |
Efalizumab
n=69 Participants
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Static Physician's Global Assessment (sPGA)
Clear
|
3 participants
|
|
Static Physician's Global Assessment (sPGA)
Minimal
|
19 participants
|
|
Static Physician's Global Assessment (sPGA)
Mild
|
20 participants
|
|
Static Physician's Global Assessment (sPGA)
Moderate
|
21 participants
|
|
Static Physician's Global Assessment (sPGA)
Severe
|
6 participants
|
|
Static Physician's Global Assessment (sPGA)
Very Severe
|
0 participants
|
Adverse Events
Efalizumab
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Efalizumab
n=70 participants at risk
Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
2/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
4/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
3/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Candidiasis
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
General disorders
Chills
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
3/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
4.3%
3/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Nervous system disorders
Dizziness
|
4.3%
3/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Nervous system disorders
Epilepsy
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
General disorders
Fatigue
|
4.3%
3/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Vascular disorders
Flushing
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Folliculitis
|
2.9%
2/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Furuncle
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Metabolism and nutrition disorders
Gout
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Nervous system disorders
Headache
|
14.3%
10/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Investigations
Heart rate increased
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Vascular disorders
Hot flush
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Influenza
|
5.7%
4/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
General disorders
Influenza like illness
|
7.1%
5/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Lower respiratory tract infection
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
2/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
2/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
5/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Oral herpes
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Vascular disorders
Orthostatic hypotension
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Otitis media
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Pharyngitis
|
2.9%
2/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
3/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.7%
4/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.9%
2/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Nervous system disorders
Sciatica
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Sinusitis
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Sweat gland infection
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.9%
2/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
8/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Urinary tract infection
|
2.9%
2/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Vascular disorders
Vascular occlusion
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Ear and labyrinth disorders
Ear pain
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Eye disorders
Conjunctivitis
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.4%
1/70 • 12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
|
Additional Information
Merck KGaA Communication Center
Merck Serono S.A., a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER