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The study was terminated after the European Medicines Evaluation Agency recommended to suspend the marketing authorisation of Raptiva in the European Union
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The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or soles scoring Palmo-plantar Pustular Psoriasis Area and Severity Index (PPPASI) ≥5 in subjects that are candidates for phototherapy or systemic therapies.
The rational of the trial is that psoriasis involving palms and/or soles is a painful condition associated with fissuring, scaling and in some instances with pustulation. Because of its localization, it is a disabling condition that limits dexterity and affects social interaction, leading to compromised quality of life; and this confers additional severity to that of plaque psoriasis on the body. The therapeutic approach for palm and sole plaque-type psoriasis usually begins with topical corticosteroid treatment. If the disease reaches a certain extent, the next step involves the addition of systemic treatments. Substances like methotrexate, retinoids and cyclosporine have shown to be efficacious, but their long-term usage is often limited by toxicity. Biologic treatments for psoriasis avoid this toxicity and offer a new therapeutic approach.
The therapeutic potential of Raptiva® to treat palm and sole psoriasis refractory to systemic treatments has been described in numerous case reports and in one placebo-controlled phase IV study. However, in all cases, the number of subjects included was low, and in most cases the trials were not prospectively designed.
Since the efficacy of Raptiva® on psoriasis of palms and soles must be determined using the validated PPPASI measure, it is necessary for scientific and ethical reasons to include a placebo arm during the first 12 weeks. Finally, as the clinical response may sometimes take longer than 12 weeks, subjects must be treated and evaluated during an additional 12-week open-label extended treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raptiva | Active Comparator | 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 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efalizumab (Raptiva) | Biological | Double-blind phase 0.7mg/kg subcutaneously (sc), followed by 1mg/kg/wk sc for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) | Minimum possible score 0, maximum possible score 72. | Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Static Physician Global Assessment Hands and Feet (sPGA - H&F) | Minimum possible score 0, maximum possible score 4. | Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit |
| Psoriasis Area and Severity Index (PASI) | Minimum possible score 0, maximum possible score 72. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Static Physician Global Assessment (SPGA) | 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 | Measured at Screening, Day 0 and Day 7 |
| Dynamic Physician's Global Assessment of Change (dPGA) | 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 | Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Direct Physical Examination Abnormalities | Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum | Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits |
| Complaint Directed Physical Examinations |
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Inclusion Criteria:
To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria:
Exclusion Criteria:
To be eligible for inclusion in this trial, the subjects must not meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Selenko-Gebauer, MD | Merck Serono S.A., Geneva | Study Director |
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Screening was performed within 2 weeks prior to starting trial treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) | Minimum possible score 0, maximum possible score 72. | Results not analysed due to early termination of the study | Posted | Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
Up to 32 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis aseptic | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu-like symptoms | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Responsible | Merck Serono S.A., a division of Merck KGaA | +49-6151-75-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| C472181 | efalizumab |
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|
| Placebo | Biological | Double-blind phase sc Placebo for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks. |
|
Number of participants undergoing complaint directed physical examinations |
| Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits) |
| Heart Rate | Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits |
| Arterial Blood Pressure | Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits |
| Temperature | Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits |
| Weight Measurements | Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Haemoglobin | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Haematocrit | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Red Cell Count | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - White Cell Count | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Platelets | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Neutrophils | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Lymphocytes | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Monocytes | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Eosinophils | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Haematology Laboratory Assessments - Basophils | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Sodium | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Potassium | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Urea | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Creatinine | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Total Bilirubin | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Total Protein | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Calcium | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Aspartate Transaminase | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Alanine Transaminase | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Clinical Chemistry Laboratory Assessments - C Reactive Protein | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
| Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test | A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study. | Measured at screening (Day -14 to Day -1) |
| Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test | A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study. | Measured at screening (Day -14 to Day -1) |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Negative Serum Pregnancy Test | Participants with negative serum human chorionic gonadotrophin pregnancy test | Number | participants |
|
| Negative Urinary Pregnancy Test | Participants with negative urinary human chorionic gonadotrophin pregnancy test | Number | participants |
|
|
| Primary | Static Physician Global Assessment Hands and Feet (sPGA - H&F) | Minimum possible score 0, maximum possible score 4. | Results not analysed due to early termination of the study | Posted | Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit |
|
|
| Primary | Psoriasis Area and Severity Index (PASI) | Minimum possible score 0, maximum possible score 72. | Results not analysed due to early termination of the study | Posted | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
| Primary | Static Physician Global Assessment (SPGA) | 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 | Results not analysed due to early termination of the study | Posted | Measured at Screening, Day 0 and Day 7 |
|
|
| Primary | Dynamic Physician's Global Assessment of Change (dPGA) | 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 | Results not analysed due to early termination of the study | Posted | Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
| Secondary | Participants With Direct Physical Examination Abnormalities | Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum | Results not analysed due to early termination of the study | Posted | Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits |
|
|
| Secondary | Complaint Directed Physical Examinations | Number of participants undergoing complaint directed physical examinations | Results not analysed due to early termination of the study | Posted | Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits) |
|
|
| Secondary | Heart Rate | Results not analysed due to early termination of the study | Posted | Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits |
|
|
| Secondary | Arterial Blood Pressure | Results not analysed due to early termination of the study | Posted | Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits |
|
|
| Secondary | Temperature | Results not analysed due to early termination of the study | Posted | Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits |
|
|
| Secondary | Weight Measurements | Results not analysed due to early termination of the study | Posted | Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
| Secondary | Haematology Laboratory Assessments - Haemoglobin | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - Haematocrit | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - Red Cell Count | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - White Cell Count | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - Platelets | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - Neutrophils | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - Lymphocytes | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - Monocytes | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - Eosinophils | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Haematology Laboratory Assessments - Basophils | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Sodium | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Potassium | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Urea | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Creatinine | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Total Bilirubin | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Total Protein | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Calcium | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Aspartate Transaminase | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Alanine Transaminase | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Clinical Chemistry Laboratory Assessments - C Reactive Protein | Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events. | Posted | Number | participants | Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits |
|
|
|
| Secondary | Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test | A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study. | Posted | Number | participants | Measured at screening (Day -14 to Day -1) |
|
|
|
| Secondary | Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test | A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study. | Posted | Number | participants | Measured at screening (Day -14 to Day -1) |
|
|
|
| 2 |
| 5 |
| 5 |
| 5 |
| EG001 | 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 | 0 | 1 | 1 | 1 |
| Osteomyelitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Anxiety attack | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Folliculitis of groin | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Intertrigo of groin | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Left eye redness | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Generalized body ache | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Swelling of left heel | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Secondary infection, both feet | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Contact dermatitis, both feet | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Maculopapular rash on body (id reaction) | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bilateral arm aches (nonspecific) | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Flu-like symptoms | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Infected right foot | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Widespread eczematous rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Telogen effluvium | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Eczematous rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cellulitis right leg | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
Not provided