Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Certolizumab Pegol (Cimzia®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certolizumab Pegol (CZP) 200 mg<br>Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter. | Drug: Certolizumab Pegol (Cimzia®)<br>* Pharmaceutical Form: Solution for injection in pre-filled syringe Route of Administration: Subcutaneous use Dose and Administration details : 2 x 1 mL Certolizumab Pegol at Week 0, followed by 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10<br>|
| Experimental: Certolizumab Pegol (CZP) 400 mg<br>Subcutaneous injections of 400 mg every 2 weeks. | Drug: Certolizumab Pegol (Cimzia®)<br>* Pharmaceutical Form: Solution for injection in pre-filled syringe Route of Administration: Subcutaneous use Dose and Administration details : 2 x 1 mL Certolizumab Pegol at Week 0, followed by 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10<br>|

What is the study measuring?
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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 | 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 | 

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 | 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 | 
| 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to severe chronic plaque psoriasis, anti TNF α, CDP 870, Cimzia®, certolizumab pegol, retreatment