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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00329303

Enrollment

Registered

2006-05-24

Start date

2006-04-30

Completion date

2007-05-31

Last updated

2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Moderate to severe chronic plaque psoriasis, anti TNF α, CDP 870, Cimzia®, certolizumab pegol, retreatment

Brief summary

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.

Interventions

DRUGCertolizumab Pegol (Cimzia®)

* 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	Week 12 in C87040 [NCT00245765] and Week 12 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'.

Secondary

Measure	Time frame	Description
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study	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. 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 %.
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040	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. 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 %.
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study	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. 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 %.
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040	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 study C87040 of at least 90 %.
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study	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 %.
Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040	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.
Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study	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.
Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study	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.
Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study	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.
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	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.
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	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.
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	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.
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	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.
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	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.
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	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.
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	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.
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	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.
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study	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.
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	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.
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	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.
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	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.
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	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.
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	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.
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	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.
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	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.
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	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.
Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040	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.
Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study	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.
Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040	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.
Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study	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.
Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study	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)
Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study	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)
Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study	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)
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study	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)
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study	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)
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study	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)
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study	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)
Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study	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)
Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study	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)
BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study	Re-treatment Baseline in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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 %)
BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study	Week 2 of re-treatment Period in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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 %)
BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study	Week 4 of re-treatment Period in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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 %)
BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study	Week 6 of re-treatment Period in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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 %)
BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study	Week 8 of re-treatment Period in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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 %)
BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study	Week 10 of re-treatment Period in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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 %)
BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study	Week 12 of re-treatment Period in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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 %)
BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study	Last re-treatment visit in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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 %)
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study	From first treatment Baseline in C87040 to re-treatment Baseline in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040	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. 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 %.
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study	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: 1. 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 2. 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.
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study	From re-treatment Baseline in this study to last re-treatment visit in this study	Two methods were used for the evaluation of BSA: 1. 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 2. 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.
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	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.
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study	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: 1. 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 2. 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.

Countries

France, Germany

Participant flow

Recruitment details

The study started to enroll patients in April 2006 and concluded in May 2007.

Pre-assignment details

Participant Flow refers to the Intention-to-treat population.

Participants by arm

Arm	Count
Certolizumab Pegol (CZP) 200 mg Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	34
Certolizumab Pegol (CZP) 400 mg Subcutaneous injections of 400 mg every 2 weeks	37
Total Title	71
Total	142

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Decision of the sponsor	0	1
Overall Study	Lack of Efficacy	1	0
Overall Study	Patient no longer available	1	0
Overall Study	Patient relocated	0	1

Baseline characteristics

Characteristic	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg	Total Title
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	2 Participants	2 Participants
Age, Categorical Between 18 and 65 years	34 Participants	35 Participants	69 Participants
Age, Continuous	44.24 years STANDARD_DEVIATION 8.64	44.57 years STANDARD_DEVIATION 12.47	44.41 years STANDARD_DEVIATION 10.73
Sex: Female, Male Female	11 Participants	10 Participants	21 Participants
Sex: Female, Male Male	23 Participants	27 Participants	50 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 34	0 / 37
other Total, other adverse events	9 / 34	11 / 37
serious Total, serious adverse events	0 / 34	0 / 37

Outcome results

Primary

Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study

The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. The difference was calculated by 'PASI score at re-treatment Week 12' minus 'PASI score at First Treatment Week 12'.

Time frame: Week 12 in C87040 [NCT00245765] and Week 12 in this study

Population: Intention-To-Treat (ITT) population with Last Observation Carried Forward (LOCF).

Arm	Measure	Value (MEDIAN)
Certolizumab Pegol (CZP) 200 mg	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	1.25 units on a scale
Certolizumab Pegol (CZP) 400 mg	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	0.20 units on a scale

Secondary

Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040

Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 50 %.

Time frame: Week 12