{"analyses":[{"ciLowerLimit":"45.59","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"64.35","estimateComment":"Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).","groupDescription":"The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","paramType":"Estimated difference in responder rate","paramValue":"55.0","statisticalComment":"Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"35.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"54.49","estimateComment":"Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).","groupDescription":"The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Estimated difference in responder rate","paramValue":"44.9","statisticalComment":"Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"9.741","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"170.198","groupDescription":"The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO","paramType":"Odds Ratio (OR)","paramValue":"40.717","statisticalComment":"Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"6.504","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"113.453","groupDescription":"The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO","paramType":"Odds Ratio (OR)","paramValue":"27.165","statisticalComment":"Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.4"},{"groupId":"OG001","value":"48.3"},{"groupId":"OG002","value":"58.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"167"}],"units":"Participants"}],"description":"The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.","groups":[{"description":"Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:\n\n•PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.\n\nParticipants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.\n\nParticipants formed the Randomized Set (RS).","id":"OG000","title":"Placebo Q2W (RS)"},{"description":"CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:\n\n•PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.\n\nParticipants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.\n\nParticipants formed the Randomized Set (RS).","id":"OG001","title":"CZP 200 mg Q2W (RS)"},{"description":"CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:\n\n•PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W.\n\nParticipants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.\n\nParticipants formed the Randomized Set (RS).","id":"OG002","title":"CZP 400 mg Q2W (RS)"}],"paramType":"NUMBER","populationDescription":"The Randomized Set (RS) consisted of all participants randomized into the study.\n\nMissing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.","reportingStatus":"POSTED","timeFrame":"Week 16","title":"Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16","type":"SECONDARY","unitOfMeasure":"percentage of participants"}