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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005525-63 | EudraCT Number |
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The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 [NCT00245765] and Week 12 of re-treatment in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certolizumab Pegol (CZP) 200 mg | Experimental | Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter. |
|
| Certolizumab Pegol (CZP) 400 mg | Experimental | Subcutaneous injections of 400 mg every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol (Cimzia®) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study | The PASI 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. The difference was calculated by 'PASI score at re-treatment Week 12' minus 'PASI score at First Treatment Week 12'. | Week 12 in C87040 [NCT00245765] and Week 12 in this study |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI75 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 75 %. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Besançon | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22413944 | Result | Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11. |
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Participant Flow refers to the Intention-to-treat population.
The study started to enroll patients in April 2006 and concluded in May 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Certolizumab Pegol (CZP) 200 mg | Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter |
| FG001 | Certolizumab Pegol (CZP) 400 mg | Subcutaneous injections of 400 mg every 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics refer to the Intention-To-Treat (ITT) population consisting of all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Certolizumab Pegol (CZP) 200 mg | Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter |
| BG001 | Certolizumab Pegol (CZP) 400 mg | Subcutaneous injections of 400 mg every 2 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study | The PASI 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. The difference was calculated by 'PASI score at re-treatment Week 12' minus 'PASI score at First Treatment Week 12'. | Intention-To-Treat (ITT) population with Last Observation Carried Forward (LOCF). | Posted | Median | 95% Confidence Interval | units on a scale | Week 12 in C87040 [NCT00245765] and Week 12 in this study |
Over the 12 week duration of the study.
Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Certolizumab Pegol (CZP) 200 mg | Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844599 | 2273 | UCBCares@ucb.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
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| Week 12 |
| Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI75 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 75 %. | Week 12 |
| Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 50 %. | Week 12 |
| Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 50 %. | Week 12 |
| Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI90 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 90 %. | Week 12 |
| Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI90 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 90 %. | Week 12 |
| Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | First treatment Baseline in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 1 of first treatment Period in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 2 of first treatment Period in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 3 of first treatment Period in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 4 of first treatment Period in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 6 of first treatment Period in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 8 of first treatment Period in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 10 of first treatment Period in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 12 of first treatment Period in study C87040 |
| Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Re-treatment Baseline in this study |
| Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 2 of re-treatment Period in this study |
| Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 4 of re-treatment Period in this study |
| Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 6 of re-treatment Period in this study |
| Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 8 of re-treatment Period in this study |
| Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 10 of re-treatment Period in this study |
| Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Week 12 of re-treatment Period in this study |
| Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Last re-treatment visit in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 1 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040 |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040 |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 3 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040 |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040 |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040 |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040 |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040 |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040 |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to re-treatment Baseline in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Last Re-treatment Visit in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study |
| Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | From re-treatment Baseline in this study to Week 12 of re-treatment in this study |
| Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | 12 week first treatment Period in study C87040 |
| Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | 12 week re-treatment Period in this study |
| Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | 12 week first treatment Period in study C87040 |
| Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | 12 week re-treatment Period in this study |
| Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Re-treatment Baseline in this study |
| Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Week 2 of re-treatment Period in this study |
| Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Week 4 of re-treatment Period in this study |
| Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Week 6 of re-treatment Period in this study |
| Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Week 8 of re-treatment Period in this study |
| Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Week 10 of re-treatment Period in this study |
| Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Week 12 of re-treatment Period in this study |
| Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Last re-treatment visit in this study |
| Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Week 12 of re-treatment in this study |
| BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study | Two methods were used for the evaluation of BSA:
| Re-treatment Baseline in this study |
| BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Week 2 of re-treatment Period in this study |
| BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Week 4 of re-treatment Period in this study |
| BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Week 6 of re-treatment Period in this study |
| BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Week 8 of re-treatment Period in this study |
| BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Week 10 of re-treatment Period in this study |
| BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Week 12 of re-treatment Period in this study |
| BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study | Two methods were used for the evaluation of BSA:
| Last re-treatment visit in this study |
| Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study | Two methods were used for the evaluation of BSA:
| From first treatment Baseline in C87040 to re-treatment Baseline in this study |
| Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study | Two methods were used for the evaluation of BSA:
| From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study |
| Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study |
| Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study | Two methods were used for the evaluation of BSA:
| From re-treatment Baseline in this study to last re-treatment visit in this study |
| Time to Withdrawal From the Treatment Due to Lack of Efficacy or Due to AE ('Worsening or Exacerbation of Psoriasis') During the 12 Week Re-treatment Period in This Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | During the 12 week re-treatment Period in this study |
| Créteil |
| France |
| Nice | France |
| Paris | France |
| Pierre-Bénite | France |
| Berlin | Germany |
| Bonn | Germany |
| Essen | Germany |
| Frankfurt | Germany |
| Hamburg | Germany |
| Kiel | Germany |
| Mahlow | Germany |
| Mainz | Germany |
| Münster | Germany |
| Patient no longer available |
|
| Patient relocated |
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| BG002 | Total Title |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI75 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 75 %. | Intention-To-Treat (ITT) population. | Posted | Number | percentage of subjects | Week 12 |
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| Secondary | Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI75 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 75 %. | Intention-To-Treat (ITT) population. | Posted | Number | percentage of subjects | Week 12 |
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| Secondary | Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 50 %. | Intention-To-Treat (ITT) population. | Posted | Number | percentage of subjects | Week 12 |
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| Secondary | Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 50 %. | Intention-To-Treat (ITT) population. | Posted | Number | percentage of subjects | Week 12 |
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| Secondary | Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI90 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 90 %. | Intention-To-Treat (ITT) population. | Posted | Number | percentage of subjects | Week 12 |
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| Secondary | Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI90 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 90 %. | Intention-To-Treat (ITT) population. | Posted | Number | percentage of subjects | Week 12 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | First treatment Baseline in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 1 of first treatment Period in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 2 of first treatment Period in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 3 of first treatment Period in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 4 of first treatment Period in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 6 of first treatment Period in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 8 of first treatment Period in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 10 of first treatment Period in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 12 of first treatment Period in study C87040 |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Re-treatment Baseline in this study |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 2 of re-treatment Period in this study |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 4 of re-treatment Period in this study |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 6 of re-treatment Period in this study |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 8 of re-treatment Period in this study |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 10 of re-treatment Period in this study |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Week 12 of re-treatment Period in this study |
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| Secondary | Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | Last re-treatment visit in this study |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 1 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040 |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040 |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 3 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040 |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040 |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040 |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040 |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040 |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of First Treatment Period in C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Baseline value | From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040 |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to re-treatment Baseline in this study |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study |
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|
| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Baseline value | From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Last Re-treatment Visit in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage change | From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study |
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| Secondary | Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Baseline value | From re-treatment Baseline in this study to Week 12 of re-treatment in this study |
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| Secondary | Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | 12 week first treatment Period in study C87040 |
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| Secondary | Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | units on a scale | 12 week re-treatment Period in this study |
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| Secondary | Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040 | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | weeks | 12 week first treatment Period in study C87040 |
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|
| Secondary | Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study | Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. | Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | weeks | 12 week re-treatment Period in this study |
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|
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| Secondary | Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Count of Participants | Participants | Re-treatment Baseline in this study |
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|
|
| Secondary | Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Count of Participants | Participants | Week 2 of re-treatment Period in this study |
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|
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| Secondary | Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Count of Participants | Participants | Week 4 of re-treatment Period in this study |
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|
|
| Secondary | Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Count of Participants | Participants | Week 6 of re-treatment Period in this study |
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|
|
| Secondary | Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Count of Participants | Participants | Week 8 of re-treatment Period in this study |
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| Secondary | Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Count of Participants | Participants | Week 10 of re-treatment Period in this study |
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| Secondary | Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Count of Participants | Participants | Week 12 of re-treatment Period in this study |
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|
| Secondary | Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Count of Participants | Participants | Last re-treatment visit in this study |
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|
|
| Secondary | Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study | The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present) | Intention-To-Treat (ITT) population. | Posted | Number | percentage of subjects | Week 12 of re-treatment in this study |
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|
|
| Secondary | BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Body Surface Area | Re-treatment Baseline in this study |
|
|
|
| Secondary | BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Body Surface Area | Week 2 of re-treatment Period in this study |
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|
|
| Secondary | BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Body Surface Area | Week 4 of re-treatment Period in this study |
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|
| Secondary | BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Body Surface Area | Week 6 of re-treatment Period in this study |
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|
|
| Secondary | BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Body Surface Area | Week 8 of re-treatment Period in this study |
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|
| Secondary | BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Body Surface Area | Week 10 of re-treatment Period in this study |
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|
|
| Secondary | BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Body Surface Area | Week 12 of re-treatment Period in this study |
|
|
|
| Secondary | BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percentage of Body Surface Area | Last re-treatment visit in this study |
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|
|
| Secondary | Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From first treatment Baseline in C87040 to re-treatment Baseline in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study |
|
|
|
| Secondary | Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study | Two methods were used for the evaluation of BSA:
| Intention-To-Treat (ITT) population. | Posted | Median | 95% Confidence Interval | percent of total Body Surface Area | From re-treatment Baseline in this study to last re-treatment visit in this study |
|
|
|
| Secondary | Time to Withdrawal From the Treatment Due to Lack of Efficacy or Due to AE ('Worsening or Exacerbation of Psoriasis') During the 12 Week Re-treatment Period in This Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Intention-To-Treat (ITT) population. | Posted | Median | Inter-Quartile Range | days | During the 12 week re-treatment Period in this study |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 9 |
| 34 |
| EG001 | Certolizumab Pegol (CZP) 400 mg | Subcutaneous injections of 400 mg every 2 weeks | 0 | 37 | 0 | 37 | 11 | 37 |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| D007128 |
| Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Mild |
|
| Moderate |
|
| Moderate to severe |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Moderate to severe |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Moderate to severe |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Moderate to severe |
|
| Severe |
|
| Missing |
|
| Mild |
|
| Moderate |
|
| Moderate to severe |
|
| Severe |
|
| Missing |
|
| Mild |
|
| Moderate |
|
| Moderate to severe |
|
| Severe |
|
| Missing |
|
| Mild |
|
| Moderate |
|
| Moderate to severe |
|
| Severe |
|
| Missing |
|
| Mild |
|
| Moderate |
|
| Moderate to severe |
|
| Severe |
|