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Trial record 1 of 1 for:    NCT00329303
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Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis

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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:
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
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
Hide 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
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg Total Title
Hide 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
Hide 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%
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame Re-treatment Baseline in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame Week 2 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame Week 4 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame Week 6 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame Week 8 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame Week 10 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame Week 12 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Time Frame Last re-treatment visit in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From first treatment Baseline in C87040 to re-treatment Baseline in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide Description

Two methods were used for the evaluation of BSA:

  1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
  2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Time Frame From re-treatment Baseline in this study to last re-treatment visit in this study
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT) population.
Arm/Group Title Certolizumab Pegol (CZP) 200 mg Certolizumab Pegol (CZP) 400 mg
Hide 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.
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
Hide 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%) 
Hide 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%) 
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
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