TriangleNCT02346240 · 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
- 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 (RS) consisted of 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 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: •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 Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).
CZP 200 mg Q2W (RS)
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: •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. Participants 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. Participants formed the Randomized Set (RS).
CZP 400 mg Q2W (RS)
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: •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. Participants 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. Participants formed the Randomized Set (RS).
| Group | Source count |
|---|---|
| Placebo Q2W (RS) | 57 |
| CZP 200 mg Q2W (RS) | 165 |
| CZP 400 mg Q2W (RS) | 167 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Q2W (RS) | 3.8 | Not reported | Not reported | Not reported | Not reported |
| CZP 200 mg Q2W (RS) | 68.2 | Not reported | Not reported | Not reported | Not reported |
| CZP 400 mg Q2W (RS) | 74.7 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 62.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 79.59
- 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
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Estimated difference in responder rate
- param Value
- 70.9
- statistical Comment
- Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 55.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 73.63
- 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
- 64.4
- statistical Comment
- Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 17.952
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 324.094
- 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 is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
- param Type
- Odds Ratio (OR)
- param Value
- 76.277
- statistical Comment
- 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
- 13.135
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 233.782
- 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 is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO
- param Type
- Odds Ratio (OR)
- param Value
- 55.413
- statistical Comment
- 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
- 62.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 79.59
- 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
- OG002
- non Inferiority Type
- SUPERIORITY
- param Type
- Estimated difference in responder rate
- param Value
- 70.9
- statistical Comment
- Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 55.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 73.63
- 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
- 64.4
- statistical Comment
- Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 17.952
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 324.094
- 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 is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO
- param Type
- Odds Ratio (OR)
- param Value
- 76.277
- statistical Comment
- 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
- 13.135
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 233.782
- 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 is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO
- param Type
- Odds Ratio (OR)
- param Value
- 55.413
- statistical Comment
- 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
- 3.8
- group Id
- OG001
- value
- 68.2
- group Id
- OG002
- value
- 74.7
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 165
- group Id
- OG002
- value
- 167
- 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 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: •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. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants 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: •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. Participants 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. Participants 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: •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. Participants 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. Participants formed the Randomized Set (RS).
- id
- OG002
- title
- CZP 400 mg Q2W (RS)
- param Type
- NUMBER
- population Description
- The Randomized Set (RS) consisted of 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
- Week 16
- title
- Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice