- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00329303
Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis
Follow-up of Study C87040: Multicentre, Double-blind Study to Describe the Efficacy and Safety of Re-treatment With CDP870 (Certolizumab Pegol) Subcutaneous at 2 Different Dose Regimens (400 mg Initial Dose at Week 0 With 200 mg Every 2 Weeks Thereafter and 400 mg Every 2 Weeks) or Placebo for 12 Weeks, in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy, Having Responded to Treatment in Study C87040 and Having Subsequently Relapsed
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject having responded to treatment at Week 12 in study C87040 and having relapsed during the follow-up period
- Female subjects either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception.Subjects agreed to continue using adequate contraception during the study and for 12 weeks after the last dose of CDP870
Exclusion Criteria:
- Subjects with erythrodermic, guttate, generalized pustular form of psoriasis
- Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
- Positive hepatitis B surface antigen test and /or hepatitis C antibody test results
- Positive human immunodeficiency virus (HIV) test result
- White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter
- Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- Systemic Lupus Erythematosus
- Participation in a clinical study within the past 3 months except Study C87040
- Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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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Experimental: Certolizumab Pegol (CZP) 400 mg
Subcutaneous injections of 400 mg every 2 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: Week 12 in C87040 [NCT00245765] and Week 12 in this study
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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'.
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Week 12 in C87040 [NCT00245765] and Week 12 in this study
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Secondary Outcome Measures
Outcome Measure |
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
Time Frame: Week 12
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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 %. |
Week 12
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Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Time Frame: Week 12
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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
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Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Time Frame: Week 12
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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
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Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Time Frame: Week 12
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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
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Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Time Frame: Week 12
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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
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Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Time Frame: Week 12
|
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
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Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040
Time Frame: First treatment Baseline in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040
Time Frame: Week 1 of first treatment Period in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040
Time Frame: Week 2 of first treatment Period in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040
Time Frame: Week 3 of first treatment Period in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040
Time Frame: Week 4 of first treatment Period in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040
Time Frame: Week 6 of first treatment Period in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040
Time Frame: Week 8 of first treatment Period in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040
Time Frame: Week 10 of first treatment Period in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040
Time Frame: Week 12 of first treatment Period in study C87040
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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
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Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study
Time Frame: Re-treatment Baseline in this study
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study
Time Frame: Week 2 of re-treatment Period in this study
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study
Time Frame: Week 4 of re-treatment Period in this study
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study
Time Frame: Week 6 of re-treatment Period in this study
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study
Time Frame: Week 8 of re-treatment Period in this study
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study
Time Frame: Week 10 of re-treatment Period in this study
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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
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Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study
Time Frame: Week 12 of re-treatment Period in this study
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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
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Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study
Time Frame: Last re-treatment visit in this study
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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
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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
Time Frame: From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040
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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
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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
Time Frame: From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040
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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
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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
Time Frame: From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040
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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
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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
Time Frame: From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040
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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
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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
Time Frame: 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
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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
Time Frame: 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
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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
Time Frame: From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040
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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
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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
Time Frame: From first treatment Baseline in study C87040 to Week 12 of first treatment 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
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Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study
Time Frame: From first treatment Baseline in study C87040 to re-treatment Baseline in this study
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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
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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
Time Frame: From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study
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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
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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
Time Frame: From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study
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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
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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
Time Frame: 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
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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
Time Frame: 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
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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
Time Frame: 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
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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
Time Frame: 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
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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
Time Frame: From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) 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
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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
Time Frame: 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
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Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040
Time Frame: 12 week first treatment Period in study C87040
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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
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Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study
Time Frame: 12 week re-treatment Period in this study
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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
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Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040
Time Frame: 12 week first treatment Period in study C87040
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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
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Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study
Time Frame: 12 week re-treatment Period in this study
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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
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Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study
Time Frame: Re-treatment Baseline in this study
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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
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Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study
Time Frame: Week 2 of re-treatment Period in this study
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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
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Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study
Time Frame: Week 4 of re-treatment Period in this study
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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
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Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C87044
- 2005-005525-63 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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