| Primary | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). | Full analysis set (FAS) included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used to impute missing values. | | | Number | | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo | Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00041.87
- OG00159.17
- OG0029.04
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant. | Cochran-Mantel-Haenszel | | <0.0001 | Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided). | Odds Ratio (OR) | 6.46 | | | 2-Sided | 95 | 4.40 | 15.03 | | | |
|
| Primary | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (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 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values. | | | Number | | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
|
| Secondary | Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16 | Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
|
| Secondary | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16 | 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 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values. | | | Number | | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
|
| Secondary | Dermatology Life Quality Index (DLQI) Total Score | The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo | Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16. |
|
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16 | The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Least Squares Mean | Standard Error | units on a scale | | Week 4, 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo | Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16. |
|
| Secondary | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values. | | | Number | | percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo | |
|
| Secondary | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4 | 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 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values. | | | Number | | percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
|
| Secondary | Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure. | | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
|
| Secondary | Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response). | FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data. | | | Number | 95% Confidence Interval | percent probability of response | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 |
|
| Secondary | Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52 | The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by 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 percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response). | FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data. | | | Number | 95% Confidence Interval | percent probability of response | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52. | |
|
| Secondary | Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52 | The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by 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 percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response). | FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data. | | | Number | 95% Confidence Interval | percent probability of response | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52. | |
|
| Secondary | Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Median | 95% Confidence Interval | weeks | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | |
|
| Secondary | Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Median | 95% Confidence Interval | weeks | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | |
|
| Secondary | Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Median | 95% Confidence Interval | weeks | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | |
|
| Secondary | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). | FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. | | | Number | 95% Confidence Interval | percentage of participants | | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg |
|
| Secondary | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Number | | percentage of participants | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg |
|
| Secondary | Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported. | FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. | | | Number | 95% Confidence Interval | percentage of participants | | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Psoriasis Area and Severity Index (PASI) Score | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg |
|
| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg |
|
| Secondary | Psoriasis Area and Severity Index (PASI) Component Scores | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | |
|
| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg |
|
| Secondary | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
|
| Secondary | Total Body Surface Area (BSA) With Psoriasis | Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | percentage of BSA | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
|
| Secondary | Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 | Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | |
|
| Secondary | Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported. | FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. | | | Number | 95% Confidence Interval | percentage of participants | | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported. | FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. | | | Number | 95% Confidence Interval | percentage of participants | | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score | The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "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 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Number | 95% Confidence Interval | percentage of participants | | Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Nail Psoriasis Severity Index (NAPSI) Score | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 8, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg |
|
| Secondary | Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 8, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
|
| Secondary | Number of Affected Nails | Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively. | | | Mean | Standard Deviation | nails | | Baseline, Week 8, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52 | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 8, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg |
|
| Secondary | Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values. | | | Number | 95% Confidence Interval | percentage of participants | | Week 8, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response | The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values. | | | Number | 95% Confidence Interval | percentage of participants | | Week 8, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Itch Severity Item (ISI) Score | ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 | ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Dermatology Life Quality Index (DLQI) Score | The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 | The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. |
|
| Secondary | 36-Item Short-Form Health Survey Version 2, Acute (SF-36) | 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning). | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 16, 28, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) Score | HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale, and 7 items comprising the depression subscale. Each item has response option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4, 16, 28, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Work Limitation Questionnaire (WLQ) Index Score | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]). | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4, 16, 28, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. |
|
| Secondary | Percentage of Participants With Patient Global Assessment (PtGA) Scale Response | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe). | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Number | | percentage of participants | | Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG003 | Placebo, CP-690,550 10 mg |
|
| Secondary | Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response | The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from "very dissatisfied" to "very satisfied" with the study treatment. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Number | | percentage of participants | | Week 16, 28, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG003 | Placebo, CP-690,550 10 mg |
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| Secondary | Joint Pain Assessment (JPA) Score | The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain." | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4, 16, 28, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG003 |
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| Secondary | Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 16, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | |
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| Secondary | Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Mean | Standard Deviation | mm | | Baseline, Week 16, 28, 40, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 | Placebo, CP-690,550 5 mg | Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG003 |
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| Secondary | Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional | The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively. | | | Number | | events | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
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| Secondary | Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work | The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No [Y/N]): "Were you absent or on sick leave from work due to psoriasis today?", and participants unemployed (UEmp) at the time of assessment answered (Yes/No): "Are you unemployed due to your psoriasis?" Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively. | | | Number | | participants | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
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| Secondary | Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status | The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'n' signifies those participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively. | | | Number | | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
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| Secondary | Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours | The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable for specified parameter for each arm, respectively. | | | Mean | Standard Deviation | hours | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
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| Secondary | Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours | The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively. | | | Mean | Standard Deviation | percentage of scheduled hours | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. |
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| Secondary | Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work | The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means "ability to work was not affected by psoriasis", and 10 means "ability to work was completely affected by psoriasis". Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. | FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | |
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| Secondary | Family Dermatology Life Quality Index (FDLQI) Score | The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life. | FAS. Analysis population for "Placebo, CP-690,550" groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm, respectively. | | | Mean | Standard Deviation | units on a scale | | Baseline, Week 16, 52 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 mg tablet orally twice daily up to Week 52. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Week 52. | | OG002 |
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