Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT00697593
Status:
TERMINATED
Last Update Posted:
2014-02-13
First Post:
2008-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ChangE From Any Systemic psoriasiS therapY to Raptiva
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Serono S.A., a division of Merck KGaA'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 Weeks', 'description': "'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", 'eventGroups': [{'id': 'EG000', 'title': 'Efalizumab', 'description': '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', 'otherNumAtRisk': 70, 'otherNumAffected': 50, 'seriousNumAtRisk': 70, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rhonchi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sweat gland infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hematology - Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.434', 'spread': '0.039', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'packed cell volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 4 participants missing values'}, {'type': 'SECONDARY', 'title': "Static Physician's Global Assessment (sPGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'title': 'Clear', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Very Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks/Early Termination', 'description': "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).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Hematology - Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '144.8', 'spread': '13.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Hematology - Red Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '4.78', 'spread': '0.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'x10^12/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Hematology - White Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '10.06', 'spread': '2.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Hematology - Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '5.047', 'spread': '1.976', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Hematology - Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.206', 'spread': '0.130', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Hematology - Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.050', 'spread': '0.038', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Hematology - Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '0.526', 'spread': '0.205', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Hematology - Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '4.209', 'spread': '1.220', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Hematology - Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '255.5', 'spread': '64.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 4 participants missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '139.0', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '4.23', 'spread': '0.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '83.1', 'spread': '20.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Aspartate Transaminase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'spread': '9.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 2 participants missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Alanine Transaminase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '19.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '80.2', 'spread': '21.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '20.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '5.283', 'spread': '1.628', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant missing values'}, {'type': 'PRIMARY', 'title': 'Biochemistry - C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'title': 'participants with <3 mg/L', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'participants with 3-6 mg/L', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'participants with >6 mg/L', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 / Early Termination', 'description': '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', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 1 participant with missing values'}, {'type': 'PRIMARY', 'title': 'Urinalysis - pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '5.75', 'spread': '0.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing', 'unitOfMeasure': 'pH units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants missing values'}, {'type': 'PRIMARY', 'title': 'Urinalysis - Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Urinalysis - Ketones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Urinalysis - Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants with missing values'}, {'type': 'PRIMARY', 'title': 'Urinalysis - Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants with missing values'}, {'type': 'PRIMARY', 'title': 'Urinalysis - Nitrite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants with missing values'}, {'type': 'PRIMARY', 'title': 'Urinalysis - Leukocytes Esterase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Efalizumab', 'description': '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'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - 3 participants with missing values'}, {'type': 'PRIMARY', 'title': 'Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Efalizumab', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Suspension of the study by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'Subjects were to be screened for study eligibility within 14 days before Day 1'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Efalizumab', 'description': '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'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '14.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 - 40 years', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': '41 to 64 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': '>64 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "static Physician's Global Assessment (sPGA)", 'classes': [{'title': 'Clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Minimal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Very Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Numbers of participants with sPGA ratings of clear; minimal; mild; moderate; severe; or very severe', 'unitOfMeasure': 'participants'}, {'title': 'Biochemistry - C-Reactive Protein (CRP)', 'classes': [{'title': 'Participants with <3 mg/L', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'Participants with 3 mg/L-6mg/L', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Participants with >6 mg/L', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Numbers of participants with CRP values \\<3 mg/L, 3-6 mg/L, and \\>6 mg/L', 'unitOfMeasure': 'participants'}, {'title': 'Biochemistry - Alanine Transaminase (ALT)', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '12.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry - Alkaline Phosphatase', 'classes': [{'categories': [{'measurements': [{'value': '76.6', 'spread': '19.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry - Aspartate Transaminase (AST)', 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry - Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '82.9', 'spread': '18.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry - Glutamyl Transferase', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '15.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry - Potassium', 'classes': [{'categories': [{'measurements': [{'value': '4.19', 'spread': '0.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry - Values: Sodium', 'classes': [{'categories': [{'measurements': [{'value': '139.5', 'spread': '1.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry - Total Bilirubin', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '4.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Biochemistry - Urea', 'classes': [{'categories': [{'measurements': [{'value': '5.677', 'spread': '1.633', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Hematocrit', 'classes': [{'categories': [{'measurements': [{'value': '0.430', 'spread': '0.040', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'packed cell volume', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '145.0', 'spread': '13.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Red Blood Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '4.69', 'spread': '0.52', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x10^12/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - White Blood Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '7.11', 'spread': '1.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Basophils', 'classes': [{'categories': [{'measurements': [{'value': '0.032', 'spread': '0.033', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Eosinophils', 'classes': [{'categories': [{'measurements': [{'value': '0.177', 'spread': '0.135', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Lymphocytes', 'classes': [{'categories': [{'measurements': [{'value': '1.911', 'spread': '0.670', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Monocytes', 'classes': [{'categories': [{'measurements': [{'value': '0.462', 'spread': '0.188', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Neutrophils', 'classes': [{'categories': [{'measurements': [{'value': '4.533', 'spread': '1.582', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematology - Platelet Count', 'classes': [{'categories': [{'measurements': [{'value': '256.0', 'spread': '54.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urinalysis - Glucose', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with or without glucose detected in urine', 'unitOfMeasure': 'participants'}, {'title': 'Urinalysis - Ketones', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with or without ketones detected in urine', 'unitOfMeasure': 'participants'}, {'title': 'Urinalysis - Values - Nitrite', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with or without nitrite detected in urine', 'unitOfMeasure': 'participants'}, {'title': 'Urinalysis - Leukocytes Esterase', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with or without leukocytes esterase detected in urine', 'unitOfMeasure': 'participants'}, {'title': 'Urinalysis - Values - Protein', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Urinalysis - Blood', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with or without blood detected in urine', 'unitOfMeasure': 'participants'}, {'title': 'Urinalysis - pH', 'classes': [{'categories': [{'measurements': [{'value': '5.84', 'spread': '0.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH units', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'whyStopped': 'The study was terminated after the European Medicines Agency recommended to suspend the marketing authorisation of Raptiva in the European Union', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-20', 'studyFirstSubmitDate': '2008-06-11', 'resultsFirstSubmitDate': '2010-06-29', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-04', 'studyFirstPostDateStruct': {'date': '2008-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematology - Hematocrit', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - Hemoglobin', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - Red Blood Cell Count', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - White Blood Cell Count', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - Neutrophils', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - Eosinophils', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - Basophils', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - Monocytes', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - Lymphocytes', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Hematology - Platelet Count', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Sodium', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Potassium', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Creatinine', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Total Bilirubin', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Aspartate Transaminase (AST)', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Alanine Transaminase (ALT)', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Alkaline Phosphatase', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Glutamyl Transferase', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - Urea', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Blood samples were taken for clinical laboratory testing'}, {'measure': 'Biochemistry - C-Reactive Protein (CRP)', 'timeFrame': 'Week 12 / Early Termination', 'description': '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'}, {'measure': 'Urinalysis - pH', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing'}, {'measure': 'Urinalysis - Protein', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine'}, {'measure': 'Urinalysis - Ketones', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine'}, {'measure': 'Urinalysis - Glucose', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine'}, {'measure': 'Urinalysis - Blood', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine'}, {'measure': 'Urinalysis - Nitrite', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine'}, {'measure': 'Urinalysis - Leukocytes Esterase', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine'}, {'measure': 'Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis', 'timeFrame': 'Week 12 / Early Termination', 'description': 'Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above'}], 'secondaryOutcomes': [{'measure': "Static Physician's Global Assessment (sPGA)", 'timeFrame': '12 Weeks/Early Termination', 'description': "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)."}]}, 'conditionsModule': {'keywords': ['Efalizumab', 'Chronic Plaque Psoriasis', 'Transition from systemic therapies on to Efalizumab'], 'conditions': ['Chronic Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are at least 18 years old.\n2. Have plaque psoriasis with an sPGA score of at least moderate or severe at time of initiation of previous systemic treatment.\n3. Are transitioning from methotrexate, cyclosporine, retinoids, PUVA or NBUVB and initiating treatment with Raptiva according to the decision of the investigator and in accordance with the indication and the recommendations of the Raptiva Investigator Brochure, i.e. to which they have failed to respond, have a contraindication to or are intolerant of other systemic therapies.\n4. Agree to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.\n5. Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care.\n6. Women of childbearing potential must use appropriate contraception during treatment and up to the last study visit (safety follow-up visit). For men, it is also mandatory to practice contraception during participation in the trial, as there are no existing data on the effect of Raptiva on spermatogenesis.\n7. Discontinuation of any investigational drug or treatment 3 months prior to study start or as per washout requirements from previous protocol.\n\nNo primary vaccinations (e.g., tetanus, booster, influenza vaccine) for at least 14 days prior to first dose of study drug.For the purposes of this trial, women of childbearing potential is defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive."\n\nExclusion Criteria:\n\n1. Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:\n\n * Hypersensitivity to Raptiva or to any of the excipients.\n * Subjects with history of malignancies.\n * History of active tuberculosis (TB) or currently undergoing treatment for TB. Purified Protein Derivative (PPD) testing or chest X-ray is required for high-risk subjects. Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded.\n * Subjects with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.\n * Subjects with immunodeficiencies.\n2. Simultaneous participation in another clinical trial.\n3. Subjects experiencing a psoriasis exacerbation during screening period.\n4. Subjects who have previously been on Raptiva treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the subject can be included in this study.\n5. History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n6. History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia.\n7. Hepatic enzyme levels =/\\>3 times the upper limit of normal or serum creatinine level =/\\>2 times the upper limit of normal.\n8. Pregnant or breast-feeding.\n9. Any medical condition (prior or existing) that, in the judgment of the investigator or sponsor, could jeopardize the subject\'s safety following exposure to study drug.'}, 'identificationModule': {'nctId': 'NCT00697593', 'acronym': 'EASY', 'briefTitle': 'ChangE From Any Systemic psoriasiS therapY to Raptiva', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'A Phase IV Open Label Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Transitioning From Previous Systemic Antipsoriasis Therapies (Methotrexate, Cyclosporine, Retinoids or Psoralen-Ultraviolet Light A (PUVA), Narrow-Band Ultraviolet Light B (NBUVB) to Raptiva 1mg/kg/ Week Therapy.', 'orgStudyIdInfo': {'id': '27809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efalizumab', 'interventionNames': ['Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)']}], 'interventions': [{'name': 'Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)', 'type': 'DRUG', 'description': 'Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.', 'armGroupLabels': ['Efalizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2J 1C4', 'city': 'City Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Probity Medical Research'}], 'overallOfficials': [{'name': 'Nicole Selenko-Gebauer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Maria Koutsopoulou', 'oldOrganization': 'Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany'}}}}