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The study was terminated after the European Medicines Agency recommended to suspend the marketing authorisation of Raptiva in the European Union
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To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A (PUVA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efalizumab | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efalizumab - anti CD11a recombinant human monoclonal antibody | Drug | Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 12 | The proportion of subjects achieving a PGA - H&F rating of clear, almost clear, or mild at Week 12: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12 | The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 12: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Selenko-Gebauer, MD | Merck Serono S.A., Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vienna Medical School | Vienna | Austria |
During the screening period, approximately 200 subjects were to be screened for trial eligibility within 14 days before Day 1. A total of 100 subjects had been screened at the time the trial was terminated, of whom 76 subjects were enrolled in the trial.
First subject's first visit: 08 April 2008, last subject's last visit: 15 June 2009. Seventy six subjects entered the study, 46 completed the double-blind period and 31 of these then entered the open-label period. The remaining 15 entered an observational follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Efalizumab | Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment. |
| FG001 | Placebo | Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Period |
|
| |||||||||||||||||||||
| Open-label Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Efalizumab | Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 12 | The proportion of subjects achieving a PGA - H&F rating of clear, almost clear, or mild at Week 12: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet | Due to the termination of the trial, analysis of efficacy-related endpoints was not performed | Posted | 12 weeks |
|
Adverse events occurring during the 12-week double-blind period and the 12-week open-label period are reported
Treatment-emergent adverse events are reported. 'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all adverse events occurring above the reporting threshold during the double-blind period and open-label period.
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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 | Efalizumab - Double-blind Period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
Following the recommendation of the European Medicines Agency (EMEA) to suspend the marketing authorization of Raptiva® and the subsequent premature termination of this trial analysis of efficacy-related endpoints was not performed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Responsible | Merck Serono, a division of Merck KGaA, Darmstadt, Germany | +49 6151 72 5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Placebo | Drug | Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase) |
|
| Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24 | The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet | 24 weeks |
| Proportion of Participants From the Initial Placebo Group Achieving a PGA - H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24. | The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 24: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet | 24 weeks |
| Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12 | The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12. Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement | 12 weeks |
| Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12 | The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12. Cleared = 100% improvement; Excellent = 75-99% improvement | 12 weeks |
| Lack of Efficacy |
|
| Other |
|
| NOT COMPLETED |
|
|
| BG001 | Placebo | Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase) |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase) |
|
| Secondary | Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12 | The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 12: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet | Due to the termination of the trial, analysis of efficacy-related endpoints was not performed | Posted | 12 weeks |
|
|
| Secondary | Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24 | The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet | Due to the termination of the trial, analysis of efficacy-related endpoints was not performed | Posted | 24 weeks |
|
|
| Secondary | Proportion of Participants From the Initial Placebo Group Achieving a PGA - H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24. | The proportion of participants achieving a PGA - H&F rating of clear, or almost clear, at Week 24: Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet | Due to the termination of the trial, analysis of efficacy-related endpoints was not performed | Posted | 24 weeks |
|
|
| Secondary | Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12 | The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12. Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement | Due to the termination of the trial, analysis of efficacy-related endpoints was not performed | Posted | 12 weeks |
|
|
| Secondary | Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12 | The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12. Cleared = 100% improvement; Excellent = 75-99% improvement | Due to the termination of the trial, analysis of efficacy-related endpoints was not performed | Posted | 12 weeks |
|
|
| 1 |
| 51 |
| 35 |
| 51 |
| EG001 | Placebo - Double-blind Period | 1 | 25 | 13 | 25 |
| EG002 | Efalizumab - Open-label Period | 0 | 17 | 8 | 17 |
| EG003 | Placebo - Open-label Period | 2 | 14 | 7 | 14 |
| Meningitis aseptic | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Oral mucosa erosion | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Sinus congestion | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Tendon operation | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1) | Systematic Assessment |
|
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