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

• ClinicalTrials.gov Identifier: NCT00329303
• Recruitment Status: Completed
• First Posted: May 24, 2006
• Results First Posted: May 6, 2019
• Last Update Posted: May 6, 2019
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Psoriasis
• Intervention: Drug: Certolizumab Pegol (Cimzia®)
• Enrollment: 71

Participant Flow

Recruitment Details	The study started to enroll patients in April 2006 and concluded in May 2007.
Pre-assignment Details	Participant Flow refers to the Intention-to-treat population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description	Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Period Title: Overall Study
Started	34	37
Completed	32	35
Not Completed	2	2
Reason Not Completed
Lack of Efficacy	1	0
Decision of the sponsor	0	1
Patient no longer available	1	0
Patient relocated	0	1

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg	Total Title
Arm/Group Description		Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks	[Not Specified]
Overall Number of Baseline Participants		34	37	71
Baseline Analysis Population Description		Baseline Characteristics refer to the Intention-To-Treat (ITT) population consisting of all enrolled subjects.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	37 participants	71 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	34 100.0%	35 94.6%	69 97.2%
	>=65 years	0 0.0%	2 5.4%	2 2.8%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	34 participants	37 participants	71 participants
		44.24 (8.64)	44.57 (12.47)	44.41 (10.73)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	37 participants	71 participants
	Female	11 32.4%	10 27.0%	21 29.6%
	Male	23 67.6%	27 73.0%	50 70.4%

Outcome Measures

1. Primary Outcome

Title	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
Description	The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. The difference was calculated by 'PASI score at re-treatment Week 12' minus 'PASI score at First Treatment Week 12'.
Time Frame	Week 12 in C87040 [NCT00245765] and Week 12 in this study

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	1.25; (0.10 to 4.40)	0.20; (0.00 to 0.70)

2. Secondary Outcome

Title	Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Description	Determining the PASI score involves the evaluation 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 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Number; Unit of Measure: percentage of subjects
	67.6	86.5

3. Secondary Outcome

Title	Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Description	Determining the PASI score involves the evaluation 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 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Number; Unit of Measure: percentage of subjects
	50.0	75.7

4. Secondary Outcome

Title	Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 50 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Number; Unit of Measure: percentage of subjects
	76.5	89.2

5. Secondary Outcome

Title	Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Description	Determining the PASI score involves the evaluation 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 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Number; Unit of Measure: percentage of subjects
	67.6	89.2

6. Secondary Outcome

Title	Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Description	Determining the PASI score involves the evaluation 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 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Number; Unit of Measure: percentage of subjects
	35.3	48.6

7. Secondary Outcome

Title	Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Description	Determining the PASI score involves the evaluation 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 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Number; Unit of Measure: percentage of subjects
	29.4	40.5

8. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	First treatment Baseline in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	20.90; (18.40 to 25.50)	21.00; (18.30 to 23.60)

9. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 1 of first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	33	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	18.60; (12.60 to 21.80)	18.60; (15.80 to 20.60)

10. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 2 of first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	14.00; (10.10 to 18.20)	14.40; (11.10 to 16.00)

11. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 3 of first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	36
Median (95% Confidence Interval); Unit of Measure: units on a scale
	8.65; (7.20 to 12.60)	11.35; (8.40 to 13.40)

12. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 4 of first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	6.55; (5.40 to 10.30)	8.60; (6.60 to 11.40)

13. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 6 of first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	4.60; (2.00 to 6.40)	5.80; (4.40 to 7.50)

14. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 8 of first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	3.55; (2.20 to 4.70)	3.80; (2.70 to 5.00)

15. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 10 of first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	36
Median (95% Confidence Interval); Unit of Measure: units on a scale
	2.10; (1.10 to 3.80)	2.45; (1.40 to 3.60)

16. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 12 of first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	1.60; (0.90 to 2.70)	1.80; (1.20 to 2.60)

17. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Re-treatment Baseline in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	14.40; (12.40 to 17.60)	14.20; (12.90 to 17.50)

18. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 2 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	10.00; (7.90 to 11.50)	9.90; (8.20 to 13.20)

19. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 4 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	6.30; (3.40 to 7.70)	6.90; (4.30 to 8.90)

20. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 6 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	35
Median (95% Confidence Interval); Unit of Measure: units on a scale
	3.65; (2.50 to 6.40)	4.40; (2.80 to 5.80)

21. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 8 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	33	36
Median (95% Confidence Interval); Unit of Measure: units on a scale
	3.70; (1.40 to 6.00)	2.70; (1.80 to 4.80)

22. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 10 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	34
Median (95% Confidence Interval); Unit of Measure: units on a scale
	2.70; (1.20 to 5.80)	2.25; (1.20 to 3.50)

23. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Week 12 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	35
Median (95% Confidence Interval); Unit of Measure: units on a scale
	2.80; (1.40 to 6.30)	2.00; (0.60 to 3.30)

24. Secondary Outcome

Title	Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	Last re-treatment visit in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	3.35; (1.40 to 6.30)	2.00; (0.60 to 3.30)

25. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	33	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	12.70; (5.88 to 25.85)	13.17; (2.34 to 19.09)

26. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	29.94; (13.73 to 46.48)	31.90; (24.43 to 42.70)

27. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	36
Median (95% Confidence Interval); Unit of Measure: percentage change
	54.99; (40.00 to 66.95)	50.92; (44.68 to 58.93)

28. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	62.53; (47.47 to 78.83)	60.31; (50.95 to 67.41)

29. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	80.03; (66.67 to 88.86)	72.41; (66.67 to 79.55)

30. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	82.80; (73.33 to 93.17)	84.78; (74.86 to 87.79)

31. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	36
Median (95% Confidence Interval); Unit of Measure: percentage change
	87.74; (82.54 to 96.08)	89.94; (81.76 to 93.88)

32. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage of Baseline value
	92.45; (86.73 to 96.51)	90.60; (89.30 to 95.92)

33. Secondary Outcome

Title	Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to re-treatment Baseline in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	33.48; (26.96 to 38.87)	32.00; (20.63 to 37.02)

34. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	58.41; (49.12 to 68.18)	53.08; (40.14 to 57.33)

35. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	71.01; (66.37 to 80.98)	72.56; (62.30 to 79.31)

36. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	35
Median (95% Confidence Interval); Unit of Measure: percentage change
	80.86; (71.72 to 90.00)	83.62; (75.91 to 88.41)

37. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	33	36
Median (95% Confidence Interval); Unit of Measure: percentage change
	82.00; (70.59 to 91.53)	86.46; (76.60 to 91.60)

38. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	34
Median (95% Confidence Interval); Unit of Measure: percentage change
	87.13; (77.78 to 96.19)	90.75; (82.51 to 95.65)

39. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	35
Median (95% Confidence Interval); Unit of Measure: percentage of Baseline value
	84.11; (76.47 to 95.95)	91.78; (83.47 to 96.92)

40. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage change
	83.46; (76.47 to 94.07)	87.94; (83.47 to 96.30)

41. Secondary Outcome

Title	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
Description	Determining the PASI score involves the evaluation 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.
Time Frame	From re-treatment Baseline in this study to Week 12 of re-treatment in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	35
Median (95% Confidence Interval); Unit of Measure: percentage of Baseline value
	78.75; (65.91 to 93.80)	87.59; (80.00 to 95.88)

42. Secondary Outcome

Title	Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	12 week first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	1.60; (0.80 to 2.70)	1.60; (0.80 to 2.00)

43. Secondary Outcome

Title	Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	12 week re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: units on a scale
	2.00; (1.20 to 4.20)	1.80; (0.60 to 2.80)

44. Secondary Outcome

Title	Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	12 week first treatment Period in study C87040

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: weeks
	11.00; (10.00 to 12.00)	12.00; (10.29 to 12.00)

45. Secondary Outcome

Title	Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study
Description	Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Time Frame	12 week re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: weeks
	8.00; (6.00 to 10.00)	9.86; (8.00 to 10.14)

46. Secondary Outcome

Title	Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study
Description	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)
Time Frame	Re-treatment Baseline in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Count of Participants; Unit of Measure: Participants
Clear	0 0.0%	0 0.0%
Almost clear	0 0.0%	0 0.0%
Mild	1 2.9%	1 2.7%
Moderate	14 41.2%	13 35.1%
Moderate to severe	15 44.1%	19 51.4%
Severe	4 11.8%	4 10.8%

47. Secondary Outcome

Title	Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study
Description	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)
Time Frame	Week 2 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Count of Participants; Unit of Measure: Participants
Clear	0 0.0%	0 0.0%
Almost clear	0 0.0%	0 0.0%
Mild	9 26.5%	8 21.6%
Moderate	21 61.8%	17 45.9%
Moderate to severe	2 5.9%	9 24.3%
Severe	2 5.9%	3 8.1%

48. Secondary Outcome

Title	Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study
Description	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)
Time Frame	Week 4 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Count of Participants; Unit of Measure: Participants
Clear	1 2.9%	0 0.0%
Almost clear	7 20.6%	8 21.6%
Mild	11 32.4%	11 29.7%
Moderate	13 38.2%	16 43.2%
Moderate to severe	2 5.9%	1 2.7%
Severe	0 0.0%	1 2.7%

49. Secondary Outcome

Title	Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study
Description	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)
Time Frame	Week 6 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Count of Participants; Unit of Measure: Participants
Clear	3 8.8%	4 10.8%
Almost clear	9 26.5%	8 21.6%
Mild	11 32.4%	15 40.5%
Moderate	10 29.4%	5 13.5%
Moderate to severe	1 2.9%	1 2.7%
Severe	0 0.0%	1 2.7%
Missing	0 0.0%	3 8.1%

50. Secondary Outcome

Title	Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study
Description	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)
Time Frame	Week 8 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Count of Participants; Unit of Measure: Participants
Clear	3 8.8%	5 13.5%
Almost clear	9 26.5%	14 37.8%
Mild	10 29.4%	11 29.7%
Moderate	8 23.5%	6 16.2%
Moderate to severe	3 8.8%	0 0.0%
Severe	0 0.0%	0 0.0%
Missing	1 2.9%	1 2.7%

51. Secondary Outcome

Title	Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study
Description	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)
Time Frame	Week 10 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Count of Participants; Unit of Measure: Participants
Clear	7 20.6%	5 13.5%
Almost clear	9 26.5%	15 40.5%
Mild	7 20.6%	11 29.7%
Moderate	6 17.6%	3 8.1%
Moderate to severe	3 8.8%	0 0.0%
Severe	0 0.0%	0 0.0%
Missing	2 5.9%	3 8.1%

52. Secondary Outcome

Title	Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study
Description	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)
Time Frame	Week 12 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Count of Participants; Unit of Measure: Participants
Clear	6 17.6%	10 27.0%
Almost clear	12 35.3%	11 29.7%
Mild	4 11.8%	11 29.7%
Moderate	6 17.6%	1 2.7%
Moderate to severe	3 8.8%	1 2.7%
Severe	1 2.9%	0 0.0%
Missing	2 5.9%	3 8.1%

53. Secondary Outcome

Title	Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study
Description	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)
Time Frame	Last re-treatment visit in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Count of Participants; Unit of Measure: Participants
Clear	6 17.6%	10 27.0%
Almost clear	12 35.3%	13 35.1%
Mild	5 14.7%	12 32.4%
Moderate	7 20.6%	1 2.7%
Moderate to severe	3 8.8%	1 2.7%
Severe	1 2.9%	0 0.0%

54. Secondary Outcome

Title	Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study
Description	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)
Time Frame	Week 12 of re-treatment in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Measure Type: Number; Unit of Measure: percentage of subjects
	52.9	56.8

55. Secondary Outcome

Title	BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame	Re-treatment Baseline in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage of Body Surface Area
	16.0; (13.0 to 20.0)	15.0; (12.0 to 18.0)

56. Secondary Outcome

Title	BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame	Week 2 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage of Body Surface Area
	12.5; (10.0 to 17.0)	14.0; (10.0 to 15.0)

57. Secondary Outcome

Title	BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame	Week 4 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage of Body Surface Area
	9.5; (5.0 to 13.0)	10.0; (6.0 to 14.0)

58. Secondary Outcome

Title	BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame	Week 6 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	35
Median (95% Confidence Interval); Unit of Measure: percentage of Body Surface Area
	6.0; (5.0 to 11.0)	7.0; (5.0 to 11.0)

59. Secondary Outcome

Title	BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame	Week 8 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	33	36
Median (95% Confidence Interval); Unit of Measure: percentage of Body Surface Area
	5.0; (3.0 to 10.0)	5.0; (4.0 to 10.0)

60. Secondary Outcome

Title	BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame	Week 10 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	34
Median (95% Confidence Interval); Unit of Measure: percentage of Body Surface Area
	3.0; (2.0 to 7.0)	4.0; (3.0 to 6.0)

61. Secondary Outcome

Title	BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame	Week 12 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	34
Median (95% Confidence Interval); Unit of Measure: percentage of Body Surface Area
	3.0; (2.0 to 8.0)	3.0; (1.0 to 5.0)

62. Secondary Outcome

Title	BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame	Last re-treatment visit in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percentage of Body Surface Area
	3.5; (2.0 to 10.0)	3.0; (1.0 to 5.0)

63. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From first treatment Baseline in C87040 to re-treatment Baseline in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	9.0; (3.0 to 11.0)	7.0; (5.0 to 12.0)

64. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	11.0; (9.0 to 15.0)	10.0; (7.0 to 15.0)

65. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	13.0; (10.0 to 17.0)	12.0; (10.0 to 20.0)

66. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	35
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	13.5; (12.0 to 20.0)	19.0; (10.0 to 24.0)

67. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	33	36
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	15.0; (10.0 to 20.0)	18.0; (14.0 to 26.0)

68. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	34
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	15.0; (12.0 to 23.0)	20.5; (15.0 to 30.0)

69. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	34
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	15.0; (12.0 to 23.0)	20.5; (15.0 to 28.0)

70. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	15.0; (12.0 to 19.0)	22.0; (15.0 to 28.0)

71. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	2.5; (0.0 to 5.0)	0.0; (0.0 to 1.0)

72. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	4.0; (3.0 to 8.0)	3.0; (2.0 to 4.0)

73. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	35
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	7.0; (4.0 to 11.0)	7.0; (5.0 to 11.0)

74. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	33	36
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	10.0; (3.0 to 12.0)	9.0; (6.0 to 12.0)

75. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	34
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	12.5; (5.0 to 14.0)	9.5; (7.0 to 13.0)

76. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	32	34
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	10.5; (5.0 to 16.0)	10.5; (8.0 to 13.0)

77. Secondary Outcome

Title	Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study
Description	Two methods were used for the evaluation of BSA: The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis; The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame	From re-treatment Baseline in this study to last re-treatment visit in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (95% Confidence Interval); Unit of Measure: percent of total Body Surface Area
	10.0; (5.0 to 15.0)	11.0; (8.0 to 13.0)

78. Secondary Outcome

Title	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
Description	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.
Time Frame	During the 12 week re-treatment Period in this study

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population.

Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description:	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
Overall Number of Participants Analyzed	34	37
Median (Inter-Quartile Range); Unit of Measure: days
	56.00; (56.00 to 56.00)	NA [1]; (NA to NA)

[1]

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.

Adverse Events

Time Frame	Over the 12 week duration of the study.
Adverse Event Reporting Description	Averse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Arm/Group Title	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
Arm/Group Description	Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter	Subcutaneous injections of 400 mg every 2 weeks
All-Cause Mortality
	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/34 (0.00%)	0/37 (0.00%)
Serious Adverse Events
	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/34 (0.00%)	0/37 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Certolizumab Pegol (CZP) 200 mg	Certolizumab Pegol (CZP) 400 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	9/34 (26.47%)	11/37 (29.73%)
General disorders
Asthenia * 1	0/34 (0.00%)	2/37 (5.41%)
Infections and infestations
Nasopharyngitis * 1	5/34 (14.71%)	3/37 (8.11%)
Tonsillitis * 1	0/34 (0.00%)	2/37 (5.41%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	2/34 (5.88%)	0/37 (0.00%)
Tendonitis * 1	0/34 (0.00%)	2/37 (5.41%)
Nervous system disorders
Headache * 1	1/34 (2.94%)	3/37 (8.11%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	0/34 (0.00%)	2/37 (5.41%)
Pharyngolaryngeal pain * 1	2/34 (5.88%)	1/37 (2.70%)
Skin and subcutaneous tissue disorders
Psoriasis * 1	4/34 (11.76%)	1/37 (2.70%)
1 Term from vocabulary, MedDRA; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: +1844599 ext 2273
• EMail: UCBCares@ucb.com

Publications of Results:

Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00329303
• Other Study ID Numbers: C87044; 2005-005525-63 ( EudraCT Number )
• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Results First Submitted: June 22, 2018
• Results First Posted: May 6, 2019
• Last Update Posted: May 6, 2019