Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT05758402
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2023-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '1 862 778 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': {'description': 'Safety evaluation was not applicable as no drug was involved.', 'eventGroups': [{'id': 'EG000', 'title': 'EARP Group', 'description': 'For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Routine Practice Group', 'description': "In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Detection Rate of Psoriatic Arthritis (PsA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EARP Group', 'description': 'For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.'}, {'id': 'OG001', 'title': 'Routine Practice Group', 'description': "In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.544', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '-2.71', 'ciUpperLimit': '5.13', 'estimateComment': 'Rate difference = detection rate of PsA in EARP group - detection rate of PsA in routine practice group', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 1)', 'description': "After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared.\n\nThe detection rate of Psoriatic Arthritis (PsA) amongst moderate to severe Psoriasis (PsO) patients between the EARP group and the Routine practice groups was defined as the percentage of patients with true positive results divided by all patients in each EARP and Routine practice group.\n\nThe true positive results were defined as patients with a classification criteria for psoriatic arthritis (CASPAR) score \\>= 3 among EARP \\>= 3 for the EARP group and among those suspected of PsA by investigator's judgement for the Routine Practice group.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': "Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EARP Group', 'description': 'For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.'}, {'id': 'OG001', 'title': 'Routine Practice Group', 'description': "In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR."}], 'classes': [{'title': 'Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}, {'title': 'Positive Predictive Value (PPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Negative Predictive Value (NPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.256', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Sensitivity', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Specificity', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.336', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Positive Predictive Value (PPV)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.490', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Negative Predictive Value (NPV)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Sensitivity was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false negative (FN).\n\nSpecificity was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false positive (FP).\n\nPositive predictive value (PPV) was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false positive (FP).\n\nNegative predictive value (NPV) was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false negative (FN).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Age Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'categories': [{'measurements': [{'value': '48.14', 'spread': '12.13', 'groupId': 'OG000'}, {'value': '44.02', 'spread': '14.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.101', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Age characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Age characteristics between patients with PsA and without PsA were analyzed and compared.', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Gender Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'categories': [{'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}, {'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.836', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Gender characteristics', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Gender characteristics between patients with PsA and without PsA were analyzed and compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Body Mass Index (BMI) Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'categories': [{'measurements': [{'value': '25.02', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '25.76', 'spread': '4.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.520', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Body Mass Index (BMI) characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Body Mass Index (BMI) characteristics between patients with PsA and without PsA were analyzed and compared.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Drinking and Smoking History Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'title': 'Drinking history', 'categories': [{'title': 'Current', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}, {'title': 'Past', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Smoking history', 'categories': [{'title': 'Current', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}, {'title': 'Past', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.216', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Drinking history characteristics', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.719', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Smoking history characteristics', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Drinking and smoking history characteristics between patients with PsA and without PsA were analyzed and compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'categories': [{'measurements': [{'value': '132.08', 'spread': '147.33', 'groupId': 'OG000'}, {'value': '118.12', 'spread': '125.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.831', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Duration of Psoriasis (PsO) characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Duration of Psoriasis (PsO) characteristics between patients with PsA and without PsA were analyzed and compared.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'title': 'Psoriasis (PsO) family history', 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}]}, {'title': 'Psoriatic Arthritis (PsA) family history', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.274', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Family history of psoriasis (PsO) characteristics', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.272', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Family history of psoriatic arthritis (PsA) characteristics', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Family history of psoriasis (PsO) and psoriatic arthritis (PsA) characteristics between patients with PsA and without PsA were analyzed and compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'categories': [{'measurements': [{'value': '13.76', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '13.62', 'spread': '4.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.622', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Psoriasis Area and Severity Index (PASI) score characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day 1)', 'description': "PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 (0% of involved area) to 6 (90-100% of involved area). Within each area, the severity is estimated by three clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 (none) to 4 (maximum). The sum of all three severity parameters is then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs).", 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'title': 'Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails)', 'categories': [{'title': 'Yes', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Presence or absence of musculoskeletal symptoms', 'categories': [{'title': 'Yes', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Status of hard-to-treat area involvement characteristics', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Status of musculoskeletal symptoms characteristics', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'The presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) and presence or absence of musculoskeletal symptoms between patients with PsA and without PsA were analyzed and compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'title': 'NAPSI score of left hand', 'categories': [{'measurements': [{'value': '10.43', 'spread': '11.21', 'groupId': 'OG000'}, {'value': '4.71', 'spread': '8.17', 'groupId': 'OG001'}]}]}, {'title': 'NAPSI score of right hand', 'categories': [{'measurements': [{'value': '9.18', 'spread': '11.10', 'groupId': 'OG000'}, {'value': '4.91', 'spread': '8.61', 'groupId': 'OG001'}]}]}, {'title': 'NAPSI score of left foot', 'categories': [{'measurements': [{'value': '9.29', 'spread': '13.06', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '9.00', 'groupId': 'OG001'}]}]}, {'title': 'NAPSI score of right foot', 'categories': [{'measurements': [{'value': '9.54', 'spread': '11.57', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '9.13', 'groupId': 'OG001'}]}]}, {'title': 'Total NAPSI score', 'categories': [{'measurements': [{'value': '38.43', 'spread': '43.45', 'groupId': 'OG000'}, {'value': '18.59', 'spread': '31.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'NAPSI score of left hand characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'NAPSI score of right hand characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'NAPSI score of left foot characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'NAPSI score of right foot characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Total NAPSI score characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'The Nail Psoriasis Severity Index (NAPSI) score is used to measure psoriasis of the nails. Each nail is divided into 4 equal and symmetrical quadrants to properly assess nail matrix and nail bed changes. Each nail is given a score for nail bed PsO and nail matrix PsO ranging from 0 (none) to 4 (present in 4/4 nail) depending on the presence of any of the features of nail PsO in that quadrant. A total score per nail is 0-8, and the range of the total scores from all nails is 0-160 (toenails are included).', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'title': 'SJC66 joint count', 'categories': [{'measurements': [{'value': '5.36', 'spread': '11.18', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '3.44', 'groupId': 'OG001'}]}]}, {'title': 'TJC68 joint count', 'categories': [{'measurements': [{'value': '6.00', 'spread': '9.88', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '3.53', 'groupId': 'OG001'}]}]}, {'title': 'SJC66/TJC68 total joint count', 'categories': [{'measurements': [{'value': '11.36', 'spread': '20.01', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '6.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'SJC66 total joint count characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'TJC68 total joint count characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'SJC66/TJC68 total joint count characteristics', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day 1)', 'description': '66 swollen and 68 tender joints are assessed (the hips are not assessed for swelling). The joint count is scored as a sum of the tender joints and a sum of the swollen joints. SJC66: swollen joint count in 66 joints; TJC68: tender joint count in 66 joints.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Solicited Medical History by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'title': 'Heart diseases', 'categories': [{'title': 'Past', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Current', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}]}, {'title': 'Stroke', 'categories': [{'title': 'Past', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Current', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}]}, {'title': 'Diabetes', 'categories': [{'title': 'Past', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Current', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}]}, {'title': 'Hyperlipidemia', 'categories': [{'title': 'Past', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Current', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension', 'categories': [{'title': 'Past', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Current', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}]}, {'title': 'Fatty liver', 'categories': [{'title': 'Past', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Current', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Heart diseases', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Stroke', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Diabetes', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hyperlipidemia', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.073', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Hypertension', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.377', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Fatty liver', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'The presence or absence of co-morbidities (heart diseases, stroke, diabetes, hyperlipidemia, hypertension and fatty liver)) between patients with PsA and without PsA were analyzed and compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With PsA', 'description': 'Participants with PsA'}, {'id': 'OG001', 'title': 'Without PsA', 'description': 'Participants without PsA'}], 'classes': [{'categories': [{'title': 'UV light therapy', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Psoralen with ultraviolet A (PUVA)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Phototherapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Laser therapy', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'The presence or absence of PsO related treatment other than medications (UV light therapy, Psoralen with ultraviolet A (PUVA), Phototherapy and Laser therapy and Naturopathy) between patients with PsA and without PsA was analyzed and compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). Only participants with PsO related treatment other than medications included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EARP Group', 'description': 'For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.'}, {'id': 'FG001', 'title': 'Routine Practice Group', 'description': "In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All enrolled participants were included in the Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '187'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '187'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 15 centers in the Republic of Korea.', 'preAssignmentDetails': 'Participants who met all inclusion criteria and none of the exclusion criteria were centrally, randomly allocated with a 1:1 ratio to either the EARP group or the Routine practice group using an Interactive Web Response System (IWRS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EARP Group', 'description': 'For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.'}, {'id': 'BG001', 'title': 'Routine Practice Group', 'description': "In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.22', 'spread': '15.00', 'groupId': 'BG000'}, {'value': '43.48', 'spread': '14.11', 'groupId': 'BG001'}, {'value': '44.33', 'spread': '14.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '169.07', 'spread': '8.87', 'groupId': 'BG000'}, {'value': '171.48', 'spread': '8.58', 'groupId': 'BG001'}, {'value': '170.29', 'spread': '8.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.41', 'spread': '16.54', 'groupId': 'BG000'}, {'value': '75.53', 'spread': '15.66', 'groupId': 'BG001'}, {'value': '74.98', 'spread': '16.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.87', 'spread': '4.65', 'groupId': 'BG000'}, {'value': '25.54', 'spread': '4.38', 'groupId': 'BG001'}, {'value': '25.70', 'spread': '4.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Drinking history', 'classes': [{'categories': [{'title': 'Current', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Past', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Never', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking history', 'classes': [{'categories': [{'title': 'Current', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Past', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Never', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Psoriasis (PsO)', 'classes': [{'categories': [{'measurements': [{'value': '124.33', 'spread': '129.16', 'groupId': 'BG000'}, {'value': '114.20', 'spread': '126.14', 'groupId': 'BG001'}, {'value': '119.19', 'spread': '127.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Psoriasis Area and Severity Index (PASI) score', 'classes': [{'categories': [{'measurements': [{'value': '13.55', 'spread': '4.78', 'groupId': 'BG000'}, {'value': '13.70', 'spread': '4.98', 'groupId': 'BG001'}, {'value': '13.63', 'spread': '4.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI.", 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Psoriasis Area and Severity Index (PASI) category', 'classes': [{'categories': [{'title': '10 to <12', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': '12 to <14', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': '14 to <16', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '16 to <18', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '18 to <20', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '>= 20', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI.", 'unitOfMeasure': 'Participants'}, {'title': 'Psoriasis (PsO) family history', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Psoriatic Arthritis (PsA) family history', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails)', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence or absence of musculoskeletal symptoms', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Nail Psoriasis Severity Index (NAPSI) score', 'classes': [{'title': 'NAPSI score of left hand', 'categories': [{'measurements': [{'value': '4.71', 'spread': '7.91', 'groupId': 'BG000'}, {'value': '5.56', 'spread': '9.14', 'groupId': 'BG001'}, {'value': '5.14', 'spread': '8.55', 'groupId': 'BG002'}]}]}, {'title': 'NAPSI score of right hand', 'categories': [{'measurements': [{'value': '4.61', 'spread': '7.94', 'groupId': 'BG000'}, {'value': '5.85', 'spread': '9.68', 'groupId': 'BG001'}, {'value': '5.24', 'spread': '8.88', 'groupId': 'BG002'}]}]}, {'title': 'NAPSI score of left foot', 'categories': [{'measurements': [{'value': '3.71', 'spread': '8.30', 'groupId': 'BG000'}, {'value': '5.71', 'spread': '10.35', 'groupId': 'BG001'}, {'value': '4.73', 'spread': '9.44', 'groupId': 'BG002'}]}]}, {'title': 'NAPSI score of right foot', 'categories': [{'measurements': [{'value': '4.01', 'spread': '8.10', 'groupId': 'BG000'}, {'value': '5.95', 'spread': '10.46', 'groupId': 'BG001'}, {'value': '4.99', 'spread': '9.41', 'groupId': 'BG002'}]}]}, {'title': 'Total NAPSI score', 'categories': [{'measurements': [{'value': '17.04', 'spread': '29.14', 'groupId': 'BG000'}, {'value': '23.06', 'spread': '36.70', 'groupId': 'BG001'}, {'value': '20.10', 'spread': '33.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Nail Psoriasis Severity Index (NAPSI) score is used to measure psoriasis of the nails. Each nail is divided into 4 equal and symmetrical quadrants to properly assess nail matrix and nail bed changes. Each nail is given a score for nail bed PsO and nail matrix PsO ranging from 0 (none) to 4 (present in 4/4 nail) depending on the presence of any of the features of nail PsO in that quadrant. A total score per nail is 0-8, and the range of the total scores from all nails is 0-160 (toenails are included).', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SJC66/TJC68 total joint count', 'classes': [{'title': 'SJC66 joint count', 'categories': [{'measurements': [{'value': '1.00', 'spread': '4.89', 'groupId': 'BG000'}, {'value': '0.77', 'spread': '4.45', 'groupId': 'BG001'}, {'value': '0.88', 'spread': '4.67', 'groupId': 'BG002'}]}]}, {'title': 'TJC68 joint count', 'categories': [{'measurements': [{'value': '1.32', 'spread': '4.53', 'groupId': 'BG000'}, {'value': '1.12', 'spread': '4.55', 'groupId': 'BG001'}, {'value': '1.22', 'spread': '4.54', 'groupId': 'BG002'}]}]}, {'title': 'SJC66/TJC68 total joint count', 'categories': [{'measurements': [{'value': '2.32', 'spread': '8.97', 'groupId': 'BG000'}, {'value': '1.89', 'spread': '8.53', 'groupId': 'BG001'}, {'value': '2.10', 'spread': '8.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '66 swollen and 68 tender joints are assessed (the hips are not assessed for swelling). The joint count is scored as a sum of the tender joints and a sum of the swollen joints. SJC66: swollen joint count in 66 joints; TJC68: tender joint count in 66 joints.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-29', 'size': 1229190, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-24T05:06', 'hasProtocol': True}, {'date': '2023-06-15', 'size': 612402, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-24T05:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2023-01-09', 'resultsFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-24', 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection Rate of Psoriatic Arthritis (PsA)', 'timeFrame': 'Visit 1 (Day 1)', 'description': "After the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared.\n\nThe detection rate of Psoriatic Arthritis (PsA) amongst moderate to severe Psoriasis (PsO) patients between the EARP group and the Routine practice groups was defined as the percentage of patients with true positive results divided by all patients in each EARP and Routine practice group.\n\nThe true positive results were defined as patients with a classification criteria for psoriatic arthritis (CASPAR) score \\>= 3 among EARP \\>= 3 for the EARP group and among those suspected of PsA by investigator's judgement for the Routine Practice group."}], 'secondaryOutcomes': [{'measure': "Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) Between EARP Questionnaire (EARP Group) and the Investigator's Judgement (Routine Practice Group)", 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Sensitivity was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false negative (FN).\n\nSpecificity was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false positive (FP).\n\nPositive predictive value (PPV) was summarized with the number and percentage of patients who have true positive (TP) among those who have true positive (TP) and false positive (FP).\n\nNegative predictive value (NPV) was summarized with the number and percentage of patients who have true negative (TN) among those who have true negative (TN) and false negative (FN).'}, {'measure': 'Age Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Age characteristics between patients with PsA and without PsA were analyzed and compared.'}, {'measure': 'Gender Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Gender characteristics between patients with PsA and without PsA were analyzed and compared.'}, {'measure': 'Body Mass Index (BMI) Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Body Mass Index (BMI) characteristics between patients with PsA and without PsA were analyzed and compared.'}, {'measure': 'Drinking and Smoking History Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Drinking and smoking history characteristics between patients with PsA and without PsA were analyzed and compared.'}, {'measure': 'Duration of Psoriasis (PsO) Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Duration of Psoriasis (PsO) characteristics between patients with PsA and without PsA were analyzed and compared.'}, {'measure': 'Family History of Psoriasis (PsO) and Psoriatic Arthritis (PsA) Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'Family history of psoriasis (PsO) and psoriatic arthritis (PsA) characteristics between patients with PsA and without PsA were analyzed and compared.'}, {'measure': 'Psoriasis Area and Severity Index (PASI) Score Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': "PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). The body is divided into four sections (head (H) (10% of a person's skin); arms (A) (20%); trunk (T) (30%); legs (L) (40%)). Each of these areas is scored by itself, and then the four scores are combined into the final PASI. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 (0% of involved area) to 6 (90-100% of involved area). Within each area, the severity is estimated by three clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity parameters are measured on a scale of 0 (none) to 4 (maximum). The sum of all three severity parameters is then calculated for each section of skin, multiplied by the area score for that area and multiplied by weight of respective section (0.1 for head, 0.2 for arms, 0.3 for body and 0.4 for legs)."}, {'measure': 'The Status of Hard-to-treat Area Involvement and Musculoskeletal Symptoms Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'The presence or absence of hard-to-treat area involvement (scalp, palmoplantar, nails) and presence or absence of musculoskeletal symptoms between patients with PsA and without PsA were analyzed and compared.'}, {'measure': 'Nail Psoriasis Severity Index (NAPSI) Score Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'The Nail Psoriasis Severity Index (NAPSI) score is used to measure psoriasis of the nails. Each nail is divided into 4 equal and symmetrical quadrants to properly assess nail matrix and nail bed changes. Each nail is given a score for nail bed PsO and nail matrix PsO ranging from 0 (none) to 4 (present in 4/4 nail) depending on the presence of any of the features of nail PsO in that quadrant. A total score per nail is 0-8, and the range of the total scores from all nails is 0-160 (toenails are included).'}, {'measure': 'SJC66/TJC68 Total Joint Count Characteristics by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': '66 swollen and 68 tender joints are assessed (the hips are not assessed for swelling). The joint count is scored as a sum of the tender joints and a sum of the swollen joints. SJC66: swollen joint count in 66 joints; TJC68: tender joint count in 66 joints.'}, {'measure': 'Solicited Medical History by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'The presence or absence of co-morbidities (heart diseases, stroke, diabetes, hyperlipidemia, hypertension and fatty liver)) between patients with PsA and without PsA were analyzed and compared.'}, {'measure': 'Percentage of Participants With PsO Related Treatment Other Than Medications by Participants With or Without PsA', 'timeFrame': 'Visit 1 (Day 1)', 'description': 'The presence or absence of PsO related treatment other than medications (UV light therapy, Psoralen with ultraviolet A (PUVA), Phototherapy and Laser therapy and Naturopathy) between patients with PsA and without PsA was analyzed and compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriatic arthritis', 'PsA', 'Psoriasis', 'PsO', 'Early arthritis for psoriatic patients', 'EARP', 'Classification criteria for psoriatic arthritis', 'CASPAR'], 'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2410', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'This was a randomized, open, parallel, controlled, multi-center, interventional, cross-sectional study to evaluate the detection rate of Psoriatic arthritis (PsA) in Korean moderate to severe Psoriasis (PsO) patients with or without the Early arthritis for psoriatic patients (EARP) screening.', 'detailedDescription': "All procedures for each patient were performed for one day. If an additional time was required depending on the circumstances of the institution and so on, the data specified in this study protocol were recommended to be collected as soon as possible. After the participants enrolled in this study, they were assessed whether they met the inclusion/exclusion criteria. In terms of the severity of PsO, it was assessed with the Psoriasis Area and Severity Index (PASI) and if the score of 10 or higher was defined as moderate to severe PsO. A total 368 eligible participants were randomized 1:1 ratio into the EARP group and the Routine practice group.\n\nFor the EARP group, the investigator asked the participants about the EARP questionnaire consisting of 10 questions. When the EARP score \\>= 3, the participants were suspected for having potential PsA. For Routine practice group, the investigator selected the participants suspected of PsA in consideration of the various clinical characteristics of the participants.\n\nAfter the completion of EARP questionnaire evaluation and the investigator's judgement as per routine practice in each group, all the participants were evaluated using Classification criteria for psoriatic arthritis (CASPAR). According to the CASPAR, participants having inflammatory articular disease with 3 or more points from the CASPAR were diagnosed as PsA, and the detection rate of PsA in each group was evaluated and compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who is \\>= 19 years of age at the time of study enrollment\n* Patient who had an established diagnosis of PsO based upon clinical evidence and documented medical history\n* Patient who is moderate to severe PsO (Psoriasis Area and Severity Index (PASI) score \\>= 10)\n* Patient who is willing and able to comply with study procedures\n* Patient who is able to provide the informed consent form (ICF)\n\nExclusion Criteria:\n\n* Patients who have formal pre-existing diagnosis of PsA\n* Patients who have ever received treatment with biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)\n* Patients who currently receive systemic glucocorticoids\n* Patients who currently receive opioid analgesics\n* Patients who has other known pre-existing dermatological or rheumatological diseases:\n\n * Non-plaque psoriasis\n * Rheumatoid arthritis\n * Osteoarthritis\n * Gout\n * Reactive arthritis\n * Ankylosing spondylitis\n * Axial spondyloarthritis\n * Enteropathic arthritis\n * Plantar fasciitis\n * Systemic lupus erythematosus (SLE)\n* Female patients who are pregnant\n* Patients who are participating in other interventional clinical trials\n* Patients who have already had PsA screening via screening questionnaires or imaging'}, 'identificationModule': {'nctId': 'NCT05758402', 'acronym': 'ASAP', 'briefTitle': 'A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study)', 'orgStudyIdInfo': {'id': 'CAIN457AKR04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EARP group', 'description': 'For the EARP group, the investigator provided this questionnaire to participants, who filled out it based on their symptoms. Afterwards, the investigator calculated the total score of the questionnaire answered by the participant, and further evaluated the participants using the CASPAR.', 'interventionNames': ['Diagnostic Test: EARP group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine practice group', 'description': "In the control group, PsA risk was assessed in moderate to severe PsO patients as per routine practice without using the EARP screening. After the completion of PsA risk assessment via routine practice according to the investigator's judgement, the participants were further evaluated using the CASPAR.", 'interventionNames': ['Diagnostic Test: Routine practice group']}], 'interventions': [{'name': 'Routine practice group', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine practice group', 'armGroupLabels': ['Routine practice group']}, {'name': 'EARP group', 'type': 'DIAGNOSTIC_TEST', 'description': 'EARP group', 'armGroupLabels': ['EARP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Bundang Gu', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site'}, {'zip': '463-712', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '02447', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '14647', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '501171', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04763', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07441', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-746', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '41944', 'city': 'Taegu', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.88889, 'lon': 128.07278}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}