Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT04398732
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2020-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not applicable as adverse events were not collected for the study', 'description': 'Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not meet, hence adverse events were not collected and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Percent Body Surface Area (BSA) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21', 'spread': '17.12191578', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis was performed on change from Baseline in percent BSA at Month 12.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis.", 'unitOfMeasure': 'Percent BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.2', 'spread': '5.632051136', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis was performed on change from baseline in DLQI at Month 12.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.44', 'spread': '9.062008607', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis was performed on change from baseline in PASI at Month 12.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': 'The PASI quantifies the severity of a participant\'s psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin\\], and lower limbs \\[including buttocks\\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Participants Adherent to Treatment', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice and were adherent to treatment. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}, {'id': 'OG001', 'title': 'Etanercept: Participants Not Adherent to Treatment', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real clinical practice and were not adherent to treatment. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.56', 'spread': '19.030', 'groupId': 'OG000'}, {'value': '32.84', 'spread': '21.324', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 4', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 12', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of body region was counted. Maximum number of handprints were 10 for head and neck,20 for upper limbs,30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. % BSA for body region=total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA=greater severity of psoriasis. This outcome measure evaluated comparison in % BSA between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.", 'unitOfMeasure': 'Percent BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Number Analyzed" signifies participants evaluable at specific time points.'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Participants Adherent to Treatment', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice and were adherent to treatment. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}, {'id': 'OG001', 'title': 'Etanercept: Participants Not Adherent to Treatment', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real clinical practice and were not adherent to treatment. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.50', 'spread': '4.438', 'groupId': 'OG000'}, {'value': '24.94', 'spread': '2.838', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 4', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 12', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison in DLQI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Number Analyzed" signifies participants evaluable at specific time points.'}, {'type': 'SECONDARY', 'title': 'Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: Participants Adherent to Treatment', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice and were adherent to treatment. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}, {'id': 'OG001', 'title': 'Etanercept: Participants Not Adherent to Treatment', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real clinical practice and were not adherent to treatment. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.980', 'spread': '10.0055', 'groupId': 'OG000'}, {'value': '22.458', 'spread': '12.6765', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '15.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 4', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 12', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': 'The PASI quantifies the severity of a participant\'s psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin\\], and lower limbs \\[including buttocks\\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison in PASI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Number Analyzed" signifies participants evaluable at specific time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Percent Body Surface Area (BSA) at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.8', 'spread': '17.39310208', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis was performed on change from Baseline in percent BSA at Month 4.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis.", 'unitOfMeasure': 'Percent BSA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.3', 'spread': '5.70876519', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis was performed on change from baseline in DLQI at Month 4.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.64', 'spread': '10.35036231', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis was performed on change from baseline in PASI at Month 4.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': 'The PASI quantifies the severity of a participant\'s psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin\\], and lower limbs \\[including buttocks\\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 milligrams \\[mg\\] administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '486'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '436'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Participants Who Did Not Meet Entrance Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}]}]}], 'recruitmentDetails': "Data of Iraq's participants aged greater than or equal to (\\>=) 18 years, who received etanercept for at least 1 year for treatment of moderate to severe plaque psoriasis at dermatology center in the Baghdad teaching hospital were included in the study. Available data of maximum 5 years were evaluated in approximately 2.8 months of this retrospective, observational study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat moderate-to-severe plaque psoriasis for at least 1 year under standard real world clinical practice. (In Iraq, the recommended dose of etanercept \\[Enbrel\\] is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly might be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly). Data of these participants were studied for approximately 2.8 months in this study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32.5', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '240', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '246', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Analysis was performed on all participants whose data were included in this study for retrospective observation.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-28', 'size': 1671769, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-30T10:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2020-05-20', 'resultsFirstSubmitDate': '2021-09-30', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-30', 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Percent Body Surface Area (BSA) at Month 4', 'timeFrame': 'Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 % for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis."}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4', 'timeFrame': 'Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants."}, {'measure': 'Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4', 'timeFrame': 'Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': 'The PASI quantifies the severity of a participant\'s psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin\\], and lower limbs \\[including buttocks\\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Percent Body Surface Area (BSA) at Month 12', 'timeFrame': 'Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint equal to (=) 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis."}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12', 'timeFrame': 'Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants."}, {'measure': 'Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12', 'timeFrame': 'Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': 'The PASI quantifies the severity of a participant\'s psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin\\], and lower limbs \\[including buttocks\\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis.'}], 'secondaryOutcomes': [{'measure': 'Percent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment', 'timeFrame': 'Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of body region was counted. Maximum number of handprints were 10 for head and neck,20 for upper limbs,30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. % BSA for body region=total number of handprints in a body region \\* % surface area equivalent to 1 handprint. Overall % BSA for individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA=greater severity of psoriasis. This outcome measure evaluated comparison in % BSA between participants adherent and not adherent to treatment at Baseline, Month 4 and 12."}, {'measure': 'Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment', 'timeFrame': 'Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': "DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. This outcome measure evaluated comparison in DLQI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12."}, {'measure': 'Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment', 'timeFrame': 'Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)', 'description': 'The PASI quantifies the severity of a participant\'s psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \\[including axillae and groin\\], and lower limbs \\[including buttocks\\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 (no disease) to 72.0 (maximum disease), with higher scores representing greater severity of psoriasis. This outcome measure evaluated comparison in PASI score between participants adherent and not adherent to treatment at Baseline, Month 4 and 12.'}]}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1801412', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate available local data in Iraqi patients with moderate to severe psoriasis on Enbrel treatment with regards to efficacy, treatment regimen adherence and patient characterization (i.e. age, gender, smoking status) using data from the Dermatologists in Baghdad Teaching Hospital registry'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients data from the local registry at the Dermatology Center of Baghdad Teaching Hospital registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of moderate to severe plaque psoriasis receiving etanercept treatment for a minimum duration of 1 year.\n* Age ≥18 years old.\n* No history of using a biological treatment, other than etanercept, for treatment of moderate to severe plaque psoriasis or any other reason.\n\nExclusion Criteria:\n\n* Etanercept use for treatment moderate to severe plaque psoriasis less than 1 year duration.\n* Previous use of other biological treatments for any reason'}, 'identificationModule': {'nctId': 'NCT04398732', 'briefTitle': 'Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Efficacy of Etanercept in Iraqi Patients With Moderate to Severe Psoriasis: 5 Years Data From Local Registry.', 'orgStudyIdInfo': {'id': 'B1801412'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with moderate to severe plaque psoriasis', 'description': 'Iraqi patients diagnosed with moderate to severe plaque psoriasis that received Enbrel as treatment for disease.', 'interventionNames': ['Drug: Enbrel']}], 'interventions': [{'name': 'Enbrel', 'type': 'DRUG', 'description': 'As provided in real world practice', 'armGroupLabels': ['Patients with moderate to severe plaque psoriasis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Pfizer', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}