TriangleNCT02326298 · OUTCOME
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- At Week 16
What was measured
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Analysis population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
Groups in this outcome
Placebo Q2W (RS)
Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continued to receive Placebo. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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 Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants formed the Randomized Set (RS).
CZP 200 mg Q2W (RS)
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS.
CZP 400 mg Q2W (RS)
CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS.
| Group | Source count |
|---|---|
| Placebo Q2W (RS) | 51 |
| CZP 200 mg Q2W (RS) | 95 |
| CZP 400 mg Q2W (RS) | 88 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Q2W (RS) | 6.5 | Not reported | Not reported | Not reported | Not reported |
| CZP 200 mg Q2W (RS) | 66.5 | Not reported | Not reported | Not reported | Not reported |
| CZP 400 mg Q2W (RS) | 75.8 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 6.968
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 120.371
- group Description
- The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.
- param Type
- Odds Ratio (OR)
- param Value
- 28.962
- statistical Comment
- Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 10.657
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 195.634
- group Description
- The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
- param Type
- Odds Ratio (OR)
- param Value
- 45.660
- statistical Comment
- Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 47.92
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 72.17
- estimate Comment
- Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
- group Description
- The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Estimated difference in responder rate
- param Value
- 60.0
- statistical Comment
- Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 57.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 80.99
- estimate Comment
- Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).
- group Description
- The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Estimated difference in responder rate
- param Value
- 69.3
- statistical Comment
- Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 6.968
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 120.371
- group Description
- The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.
- param Type
- Odds Ratio (OR)
- param Value
- 28.962
- statistical Comment
- Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 10.657
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 97.5
- ci Upper Limit
- 195.634
- group Description
- The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
- param Type
- Odds Ratio (OR)
- param Value
- 45.660
- statistical Comment
- Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 47.92
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 72.17
- estimate Comment
- Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).
- group Description
- The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Estimated difference in responder rate
- param Value
- 60.0
- statistical Comment
- Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 57.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 80.99
- estimate Comment
- Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).
- group Description
- The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Estimated difference in responder rate
- param Value
- 69.3
- statistical Comment
- Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6.5
- group Id
- OG001
- value
- 66.5
- group Id
- OG002
- value
- 75.8
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 95
- group Id
- OG002
- value
- 88
- units
- Participants
- description
- The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
- groups
- description
- Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continued to receive Placebo. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants formed the Randomized Set (RS).
- id
- OG000
- title
- Placebo Q2W (RS)
- description
- CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS.
- id
- OG001
- title
- CZP 200 mg Q2W (RS)
- description
- CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS.
- id
- OG002
- title
- CZP 400 mg Q2W (RS)
- param Type
- NUMBER
- population Description
- The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
- reporting Status
- POSTED
- time Frame
- At Week 16
- title
- Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice