Trial Outcomes & Findings for Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis (NCT NCT00329303)

NCT ID: NCT00329303

Last Updated: 2019-05-06

Results Overview

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'.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 71 participants
• Primary outcome timeframe: Week 12 in C87040 [NCT00245765] and Week 12 in this study
• Results posted on: 2019-05-06

Participant Flow

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

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

Participant milestones

Measure	Certolizumab Pegol (CZP) 200 mg Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol (CZP) 400 mg Subcutaneous injections of 400 mg every 2 weeks
Overall Study STARTED	34	37
Overall Study COMPLETED	32	35
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Certolizumab Pegol (CZP) 200 mg Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol (CZP) 400 mg Subcutaneous injections of 400 mg every 2 weeks
Overall Study Lack of Efficacy	1	0
Overall Study Decision of the sponsor	0	1
Overall Study Patient no longer available	1	0
Overall Study Patient relocated	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Total Title n=71 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	44.24 years STANDARD_DEVIATION 8.64 • n=5 Participants	44.57 years STANDARD_DEVIATION 12.47 • n=7 Participants	44.41 years STANDARD_DEVIATION 10.73 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12 in C87040 [NCT00245765] and Week 12 in this study

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

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'.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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 Interval 0.0 to 0.7	1.25 units on a scale Interval 0.1 to 4.4

SECONDARY outcome

Timeframe: Week 12

Population: Intention-To-Treat (ITT) population.

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 %.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040	86.5 percentage of subjects	67.6 percentage of subjects

SECONDARY outcome

Timeframe: Week 12

Population: Intention-To-Treat (ITT) population.

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 %.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study	75.7 percentage of subjects	50.0 percentage of subjects

SECONDARY outcome

Timeframe: Week 12

Population: Intention-To-Treat (ITT) population.

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 %.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040	89.2 percentage of subjects	76.5 percentage of subjects

SECONDARY outcome

Timeframe: Week 12

Population: Intention-To-Treat (ITT) population.

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 %.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study	89.2 percentage of subjects	67.6 percentage of subjects

SECONDARY outcome

Timeframe: Week 12

Population: Intention-To-Treat (ITT) population.

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 %.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040	48.6 percentage of subjects	35.3 percentage of subjects

SECONDARY outcome

Timeframe: Week 12

Population: Intention-To-Treat (ITT) population.

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 %.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study	40.5 percentage of subjects	29.4 percentage of subjects

SECONDARY outcome

Timeframe: First treatment Baseline in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040	21.00 units on a scale Interval 18.3 to 23.6	20.90 units on a scale Interval 18.4 to 25.5

SECONDARY outcome

Timeframe: Week 1 of first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=33 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040	18.60 units on a scale Interval 15.8 to 20.6	18.60 units on a scale Interval 12.6 to 21.8

SECONDARY outcome

Timeframe: Week 2 of first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040	14.40 units on a scale Interval 11.1 to 16.0	14.00 units on a scale Interval 10.1 to 18.2

SECONDARY outcome

Timeframe: Week 3 of first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040	11.35 units on a scale Interval 8.4 to 13.4	8.65 units on a scale Interval 7.2 to 12.6

SECONDARY outcome

Timeframe: Week 4 of first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040	8.60 units on a scale Interval 6.6 to 11.4	6.55 units on a scale Interval 5.4 to 10.3

SECONDARY outcome

Timeframe: Week 6 of first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040	5.80 units on a scale Interval 4.4 to 7.5	4.60 units on a scale Interval 2.0 to 6.4

SECONDARY outcome

Timeframe: Week 8 of first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040	3.80 units on a scale Interval 2.7 to 5.0	3.55 units on a scale Interval 2.2 to 4.7

SECONDARY outcome

Timeframe: Week 10 of first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040	2.45 units on a scale Interval 1.4 to 3.6	2.10 units on a scale Interval 1.1 to 3.8

SECONDARY outcome

Timeframe: Week 12 of first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040	1.80 units on a scale Interval 1.2 to 2.6	1.60 units on a scale Interval 0.9 to 2.7

SECONDARY outcome

Timeframe: Re-treatment Baseline in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study	14.20 units on a scale Interval 12.9 to 17.5	14.40 units on a scale Interval 12.4 to 17.6

SECONDARY outcome

Timeframe: Week 2 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study	9.90 units on a scale Interval 8.2 to 13.2	10.00 units on a scale Interval 7.9 to 11.5

SECONDARY outcome

Timeframe: Week 4 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study	6.90 units on a scale Interval 4.3 to 8.9	6.30 units on a scale Interval 3.4 to 7.7

SECONDARY outcome

Timeframe: Week 6 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=35 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study	4.40 units on a scale Interval 2.8 to 5.8	3.65 units on a scale Interval 2.5 to 6.4

SECONDARY outcome

Timeframe: Week 8 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=33 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study	2.70 units on a scale Interval 1.8 to 4.8	3.70 units on a scale Interval 1.4 to 6.0

SECONDARY outcome

Timeframe: Week 10 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=34 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study	2.25 units on a scale Interval 1.2 to 3.5	2.70 units on a scale Interval 1.2 to 5.8

SECONDARY outcome

Timeframe: Week 12 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=35 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study	2.00 units on a scale Interval 0.6 to 3.3	2.80 units on a scale Interval 1.4 to 6.3

SECONDARY outcome

Timeframe: Last re-treatment visit in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study	2.00 units on a scale Interval 0.6 to 3.3	3.35 units on a scale Interval 1.4 to 6.3

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=33 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	13.17 percentage change Interval 2.34 to 19.09	12.70 percentage change Interval 5.88 to 25.85

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	31.90 percentage change Interval 24.43 to 42.7	29.94 percentage change Interval 13.73 to 46.48

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	50.92 percentage change Interval 44.68 to 58.93	54.99 percentage change Interval 40.0 to 66.95

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	60.31 percentage change Interval 50.95 to 67.41	62.53 percentage change Interval 47.47 to 78.83

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	72.41 percentage change Interval 66.67 to 79.55	80.03 percentage change Interval 66.67 to 88.86

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	84.78 percentage change Interval 74.86 to 87.79	82.80 percentage change Interval 73.33 to 93.17

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	89.94 percentage change Interval 81.76 to 93.88	87.74 percentage change Interval 82.54 to 96.08

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	90.60 percentage of Baseline value Interval 89.3 to 95.92	92.45 percentage of Baseline value Interval 86.73 to 96.51

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to re-treatment Baseline in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study	32.00 percentage change Interval 20.63 to 37.02	33.48 percentage change Interval 26.96 to 38.87

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	53.08 percentage change Interval 40.14 to 57.33	58.41 percentage change Interval 49.12 to 68.18

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	72.56 percentage change Interval 62.3 to 79.31	71.01 percentage change Interval 66.37 to 80.98

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=35 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	83.62 percentage change Interval 75.91 to 88.41	80.86 percentage change Interval 71.72 to 90.0

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=33 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	86.46 percentage change Interval 76.6 to 91.6	82.00 percentage change Interval 70.59 to 91.53

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=34 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	90.75 percentage change Interval 82.51 to 95.65	87.13 percentage change Interval 77.78 to 96.19

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=35 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	91.78 percentage of Baseline value Interval 83.47 to 96.92	84.11 percentage of Baseline value Interval 76.47 to 95.95

SECONDARY outcome

Timeframe: From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	87.94 percentage change Interval 83.47 to 96.3	83.46 percentage change Interval 76.47 to 94.07

SECONDARY outcome

Timeframe: From re-treatment Baseline in this study to Week 12 of re-treatment in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=35 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	87.59 percentage of Baseline value Interval 80.0 to 95.88	78.75 percentage of Baseline value Interval 65.91 to 93.8

SECONDARY outcome

Timeframe: 12 week first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040	1.60 units on a scale Interval 0.8 to 2.0	1.60 units on a scale Interval 0.8 to 2.7

SECONDARY outcome

Timeframe: 12 week re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study	1.80 units on a scale Interval 0.6 to 2.8	2.00 units on a scale Interval 1.2 to 4.2

SECONDARY outcome

Timeframe: 12 week first treatment Period in study C87040

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040	12.00 weeks Interval 10.29 to 12.0	11.00 weeks Interval 10.0 to 12.0

SECONDARY outcome

Timeframe: 12 week re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study	9.86 weeks Interval 8.0 to 10.14	8.00 weeks Interval 6.0 to 10.0

SECONDARY outcome

Timeframe: Re-treatment Baseline in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study Clear	0 Participants	0 Participants
Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study Almost clear	0 Participants	0 Participants
Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study Mild	1 Participants	1 Participants
Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study Moderate	13 Participants	14 Participants
Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study Moderate to severe	19 Participants	15 Participants
Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study Severe	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 2 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study Clear	0 Participants	0 Participants
Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study Almost clear	0 Participants	0 Participants
Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study Mild	8 Participants	9 Participants
Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study Moderate	17 Participants	21 Participants
Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study Moderate to severe	9 Participants	2 Participants
Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study Severe	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 4 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study Clear	0 Participants	1 Participants
Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study Almost clear	8 Participants	7 Participants
Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study Mild	11 Participants	11 Participants
Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study Moderate	16 Participants	13 Participants
Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study Moderate to severe	1 Participants	2 Participants
Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study Severe	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 6 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study Clear	4 Participants	3 Participants
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study Almost clear	8 Participants	9 Participants
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study Mild	15 Participants	11 Participants
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study Moderate	5 Participants	10 Participants
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study Moderate to severe	1 Participants	1 Participants
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study Severe	1 Participants	0 Participants
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study Missing	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 8 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study Clear	5 Participants	3 Participants
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study Almost clear	14 Participants	9 Participants
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study Mild	11 Participants	10 Participants
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study Moderate	6 Participants	8 Participants
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study Moderate to severe	0 Participants	3 Participants
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study Severe	0 Participants	0 Participants
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study Missing	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 10 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study Clear	5 Participants	7 Participants
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study Almost clear	15 Participants	9 Participants
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study Mild	11 Participants	7 Participants
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study Moderate	3 Participants	6 Participants
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study Moderate to severe	0 Participants	3 Participants
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study Severe	0 Participants	0 Participants
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study Missing	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 12 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study Clear	10 Participants	6 Participants
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study Almost clear	11 Participants	12 Participants
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study Mild	11 Participants	4 Participants
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study Moderate	1 Participants	6 Participants
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study Moderate to severe	1 Participants	3 Participants
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study Severe	0 Participants	1 Participants
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study Missing	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Last re-treatment visit in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study Clear	10 Participants	6 Participants
Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study Almost clear	13 Participants	12 Participants
Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study Mild	12 Participants	5 Participants
Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study Moderate	1 Participants	7 Participants
Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study Moderate to severe	1 Participants	3 Participants
Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study Severe	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 12 of re-treatment in this study

Population: Intention-To-Treat (ITT) population.

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)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study	56.8 percentage of subjects	52.9 percentage of subjects

SECONDARY outcome

Timeframe: Re-treatment Baseline in this study

Population: Intention-To-Treat (ITT) population.

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 %)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study	15.0 percentage of Body Surface Area Interval 12.0 to 18.0	16.0 percentage of Body Surface Area Interval 13.0 to 20.0

SECONDARY outcome

Timeframe: Week 2 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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 %)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study	14.0 percentage of Body Surface Area Interval 10.0 to 15.0	12.5 percentage of Body Surface Area Interval 10.0 to 17.0

SECONDARY outcome

Timeframe: Week 4 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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 %)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study	10.0 percentage of Body Surface Area Interval 6.0 to 14.0	9.5 percentage of Body Surface Area Interval 5.0 to 13.0

SECONDARY outcome

Timeframe: Week 6 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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 %)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=35 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study	7.0 percentage of Body Surface Area Interval 5.0 to 11.0	6.0 percentage of Body Surface Area Interval 5.0 to 11.0

SECONDARY outcome

Timeframe: Week 8 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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 %)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=33 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study	5.0 percentage of Body Surface Area Interval 4.0 to 10.0	5.0 percentage of Body Surface Area Interval 3.0 to 10.0

SECONDARY outcome

Timeframe: Week 10 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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 %)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=34 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study	4.0 percentage of Body Surface Area Interval 3.0 to 6.0	3.0 percentage of Body Surface Area Interval 2.0 to 7.0

SECONDARY outcome

Timeframe: Week 12 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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 %)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=34 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study	3.0 percentage of Body Surface Area Interval 1.0 to 5.0	3.0 percentage of Body Surface Area Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: Last re-treatment visit in this study

Population: Intention-To-Treat (ITT) population.

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 %)

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study	3.0 percentage of Body Surface Area Interval 1.0 to 5.0	3.5 percentage of Body Surface Area Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: From first treatment Baseline in C87040 to re-treatment Baseline in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study	7.0 percent of total Body Surface Area Interval 5.0 to 12.0	9.0 percent of total Body Surface Area Interval 3.0 to 11.0

SECONDARY outcome

Timeframe: From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study	10.0 percent of total Body Surface Area Interval 7.0 to 15.0	11.0 percent of total Body Surface Area Interval 9.0 to 15.0

SECONDARY outcome

Timeframe: From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study	12.0 percent of total Body Surface Area Interval 10.0 to 20.0	13.0 percent of total Body Surface Area Interval 10.0 to 17.0

SECONDARY outcome

Timeframe: From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=35 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study	19.0 percent of total Body Surface Area Interval 10.0 to 24.0	13.5 percent of total Body Surface Area Interval 12.0 to 20.0

SECONDARY outcome

Timeframe: From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=33 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study	18.0 percent of total Body Surface Area Interval 14.0 to 26.0	15.0 percent of total Body Surface Area Interval 10.0 to 20.0

SECONDARY outcome

Timeframe: From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=34 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study	20.5 percent of total Body Surface Area Interval 15.0 to 30.0	15.0 percent of total Body Surface Area Interval 12.0 to 23.0

SECONDARY outcome

Timeframe: From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=34 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study	20.5 percent of total Body Surface Area Interval 15.0 to 28.0	15.0 percent of total Body Surface Area Interval 12.0 to 23.0

SECONDARY outcome

Timeframe: From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study	22.0 percent of total Body Surface Area Interval 15.0 to 28.0	15.0 percent of total Body Surface Area Interval 12.0 to 19.0

SECONDARY outcome

Timeframe: From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study	0.0 percent of total Body Surface Area Interval 0.0 to 1.0	2.5 percent of total Body Surface Area Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study	3.0 percent of total Body Surface Area Interval 2.0 to 4.0	4.0 percent of total Body Surface Area Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=35 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study	7.0 percent of total Body Surface Area Interval 5.0 to 11.0	7.0 percent of total Body Surface Area Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=36 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=33 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study	9.0 percent of total Body Surface Area Interval 6.0 to 12.0	10.0 percent of total Body Surface Area Interval 3.0 to 12.0

SECONDARY outcome

Timeframe: From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=34 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study	9.5 percent of total Body Surface Area Interval 7.0 to 13.0	12.5 percent of total Body Surface Area Interval 5.0 to 14.0

SECONDARY outcome

Timeframe: From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=34 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=32 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study	10.5 percent of total Body Surface Area Interval 8.0 to 13.0	10.5 percent of total Body Surface Area Interval 5.0 to 16.0

SECONDARY outcome

Timeframe: From re-treatment Baseline in this study to last re-treatment visit in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study	11.0 percent of total Body Surface Area Interval 8.0 to 13.0	10.0 percent of total Body Surface Area Interval 5.0 to 15.0

SECONDARY outcome

Timeframe: During the 12 week re-treatment Period in this study

Population: Intention-To-Treat (ITT) population.

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.

Outcome measures

Measure	Certolizumab Pegol (CZP) 400 mg n=37 Participants Subcutaneous injections of 400 mg every 2 weeks	Certolizumab Pegol (CZP) 200 mg n=34 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
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	NA days No values available since none of the subjects in the CZP 400 mg arm withdrew 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.	56.00 days Interval 56.0 to 56.0

Adverse Events

Certolizumab Pegol (CZP) 200 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Certolizumab Pegol (CZP) 400 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Certolizumab Pegol (CZP) 200 mg n=34 participants at risk Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol (CZP) 400 mg n=37 participants at risk Subcutaneous injections of 400 mg every 2 weeks
General disorders Asthenia	0.00% 0/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	5.4% 2/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Infections and infestations Nasopharyngitis	14.7% 5/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	8.1% 3/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Infections and infestations Tonsillitis	0.00% 0/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	5.4% 2/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 2/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	0.00% 0/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	5.4% 2/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Nervous system disorders Headache	2.9% 1/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	8.1% 3/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	5.4% 2/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	5.9% 2/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	2.7% 1/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Skin and subcutaneous tissue disorders Psoriasis	11.8% 4/34 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.	2.7% 1/37 • Over the 12 week duration of the study. Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.

Additional Information

UCB

Cares

Phone: +1844599

Email: UCBCares@ucb.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60