Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 8:04 AM
Study NCT ID:
NCT00438360
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2007-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'description': 'Safety Population', 'eventGroups': [{'id': 'EG000', 'title': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.', 'otherNumAtRisk': 160, 'otherNumAffected': 19, 'seriousNumAtRisk': 160, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.', 'otherNumAtRisk': 79, 'otherNumAffected': 1, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.'}], 'classes': [{'title': 'Success at 6 months', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Failure at 6 months', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score \\>75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was \\>= 75%. In all the other cases the patient was considered as success (no relapse).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Clinical Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.369', 'groupId': 'OG000'}, {'value': '0.456', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) \\>75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriasis Area and Severity Index (PASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.70', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population. Patients with a value of PASI at baseline and 24 weeks were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.12', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '10.45', 'spread': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( \\[Height(in) x Weight(lbs) \\]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed', 'unitOfMeasure': 'BSA (m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population. Patients with a value of BSA at baseline and 24 weeks were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.32', 'spread': '30.9', 'groupId': 'OG000'}, {'value': '25.44', 'spread': '31.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population. Patients with a value of VAS at baseline and 24 weeks were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Safety / Tolerability Assessed by Adverse Events', 'paramType': 'NUMBER', 'timeFrame': '24weeks', 'unitOfMeasure': 'patient', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"Started" indicates randomized patients.', 'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Intention to Treat (ITT) Population', 'achievements': [{'comment': 'These numbers are different from those started (randomized) as 2 pts from each arm never took drug.', 'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '43'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'between 18-45 years', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Between 46 and 65 years', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline measures are based on intention to treat (ITT) population.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-13', 'studyFirstSubmitDate': '2007-02-21', 'resultsFirstSubmitDate': '2010-12-15', 'studyFirstSubmitQcDate': '2007-02-21', 'lastUpdatePostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-13', 'studyFirstPostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score', 'timeFrame': '24 weeks', 'description': 'PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score \\>75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was \\>= 75%. In all the other cases the patient was considered as success (no relapse).'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Clinical Relapse', 'timeFrame': '24 weeks', 'description': 'Clinical relapse was defined as worsening of psoriasis associated with a Psoriasis Area and Severity Index (PASI) \\>75% of the PASI score assessed before the continuous treatment, or when the investigator or the patient judged it necessary to change the treatment.'}, {'measure': 'Change From Baseline in Psoriasis Area and Severity Index (PASI) Score', 'timeFrame': 'baseline and week 24', 'description': 'PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree.'}, {'measure': 'Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis', 'timeFrame': 'Baseline and week 24', 'description': 'BSA is a measure of the percentage of body surface affected by psoriasis. Using the Mosteller Formula: BSA = BSA (m²) = ( \\[Height(in) x Weight(lbs) \\]/ 3131 )½ . A covariance analysis was performed on all variables, with value assessed at visit 2 as covariate and center as effect. For each variable the changes versus the last available measures were computed'}, {'measure': 'Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus', 'timeFrame': 'Baseline and week 24', 'description': 'Target lesion pruritus as measured by the Visual Analog Scale (VAS) from 0 to 100 mm at week 24 compared to baseline (with 0 being no pruritis and 100 being maximum pruritis).'}, {'measure': 'Safety / Tolerability Assessed by Adverse Events', 'timeFrame': '24weeks'}]}, 'conditionsModule': {'keywords': ['Cyclosporine, chronic plaque psoriasis, intermittent therapy'], 'conditions': ['Chronic Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion criteria:\n\n* Outpatients 18 years of age and older (max 65 years)\n* Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period\n* Disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5 mg/kg/day) for \\>8 weeks and \\<16 weeks\n* PASI still \\<75% of PASI before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission)\n\nExclusion criteria:\n\n* Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range)\n* Severe chronic degenerative diseases\n* Severe uncontrolled hypertension\n* Body weigh \\>110 kg\n* Abnormal liver function\n* Hyperkalemia or hyperuricemia\n* Clinically significant impairment of hematopoietic and cardiovascular function\n* Concomitant therapy with nephrotoxic medications\n* Patients with malignancy or a history of malignancy\n* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception\n* Clinically significant uncontrolled bacterial, viral or fungal infection\n* Evidence of drug and/or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00438360', 'briefTitle': 'Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 24-week, Double-blind, Randomized, Placebo-controlled, Multicenter Study, to Evaluate the Effectiveness of Cyclosporine 2,5 mg/kg/Day Bid Twice a Week on Reducing Relapse Rate, in Maintenance Patients With Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'COLO400CIT04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporine A', 'description': 'Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations', 'interventionNames': ['Drug: Cyclosporine A microemulsion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cyclosporine A microemulsion', 'type': 'DRUG', 'otherNames': ['Neoral'], 'description': 'Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations', 'armGroupLabels': ['Cyclosporine A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}