Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

• ClinicalTrials.gov Identifier: NCT00245765
• Recruitment Status: Completed
• First Posted: October 28, 2005
• Results First Posted: May 3, 2019
• Last Update Posted: May 3, 2019
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Plaque Psoriasis
• Interventions: Drug: Certolizumab Pegol; Other: Placebo
• Enrollment: 176

Participant Flow

Recruitment Details	The study started to enroll patients in October 2005 and concluded in November 2006.
Pre-assignment Details	The study included a 12-week Treatment Period and a 12 to 24-week Follow-up Period. Participant Flow refers to the Intention-to-treat Set.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description	Subcutaneous injections of Placebo every 2 weeks	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	59	59	58
Safety Population [1]	58 [2]	60 [3]	57 [4]
Completed	27	45	50
Not Completed	32	14	8
Reason Not Completed
Adverse Event	1	1	0
Lack of Efficacy	14	7	0
Lost to Follow-up	1	2	0
Withdrawal by Subject	1	0	3
Other reason	2	0	1
Other	13	4	4
[1] The safety population consisted of all subjects who were exposed to study medication.; [2] One subject in the Placebo (PBO) group received one injection of CDP870 200 mg on one occasion.; [3] For safety analysis, the PBO group subj. who received CDP870 was considered to be in the 200mg group; [4] One subject in the 400 mg group was randomized by mistake but did not receive study medication.

Baseline Characteristics

Arm/Group Title		Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)	Total Title
Arm/Group Description		Subcutaneous injections of Placebo every 2 weeks	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		59	59	58	176
Baseline Analysis Population Description		Baseline Characteristics refer to the Intention-To-Treat (ITT) population consisting of all randomized subjects.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	59 participants	58 participants	176 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	54 91.5%	57 96.6%	55 94.8%	166 94.3%
	>=65 years	5 8.5%	2 3.4%	3 5.2%	10 5.7%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	59 participants	59 participants	58 participants	176 participants
		43.30 (12.78)	43.26 (10.12)	43.64 (12.36)	43.40 (11.74)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	59 participants	58 participants	176 participants
	Female	22 37.3%	15 25.4%	16 27.6%	53 30.1%
	Male	37 62.7%	44 74.6%	42 72.4%	123 69.9%

Outcome Measures

1. Primary Outcome

Title	Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12
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 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population consisting of all randomized subjects.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	59	59	58
Measure Type: Number; Unit of Measure: percentage of subjects
	6.8	74.6	82.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (ITT), Certolizumab Pegol 200 mg (ITT)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression with treatment and baseline severity of psoriasis as factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	40.2
	Confidence Interval	(2-Sided) 95%; 13.7 to 150.3
	Estimation Comments	Confidence limits are based on likelihood ratio statistics.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (ITT), Certolizumab Pegol 400 mg (ITT)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression with treatment and baseline severity of psoriasis as factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	73.4
	Confidence Interval	(2-Sided) 95%; 23.5 to 292.6
	Estimation Comments	Confidence limits are based on likelihood ratio statistics.

2. Primary Outcome

Title	Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12
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

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population consisting of all randomized subjects.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	59	59	58
Measure Type: Number; Unit of Measure: percentage of subjects
	1.7	52.5	72.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (ITT), Certolizumab Pegol 200 mg (ITT)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression with treatment and baseline severity of psoriasis as factors. Confidence limits are based on likelihood ratio statistics.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	64.1
	Confidence Interval	(2-Sided) 95%; 12.7 to 1169.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (ITT), Certolizumab Pegol 400 mg (ITT)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression with treatment and baseline severity of psoriasis as factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	162.6
	Confidence Interval	(2-Sided) 95%; 31.4 to 2999.2
	Estimation Comments	Confidence limits are based on likelihood ratio statistics.

3. Secondary Outcome

Title	Time to Psoriasis Activity and Severity Index 50 (PASI50)
Description	Time to PASI50 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI50 during the Treatment Period. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).
Time Frame	During the 12-weeks Treatment Period

Outcome Measure Data

Analysis Population Description

Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	4	44	48
Median (95% Confidence Interval); Unit of Measure: days
	56.50; (14.00 to 99.00)	21.00; (20.00 to 28.00)	22.00; (21.00 to 30.00)

4. Secondary Outcome

Title	Time to Psoriasis Activity and Severity Index 75 (PASI75)
Description	Time to PASI75 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI75 during the Treatment Period. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).
Time Frame	During the 12-weeks Treatment Period

Outcome Measure Data

Analysis Population Description

Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	4	44	48
Median (95% Confidence Interval); Unit of Measure: days
	77.50; (42.00 to 99.00)	42.50; (28.00 to 56.00)	55.50; (42.00 to 69.00)

5. Secondary Outcome

Title	Time to Relapse
Description	Time to relapse is defined as the time elapsed between the last dose and when maximal improvement in PASI from Baseline was reduced by > 50 %. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).
Time Frame	During the 12-weeks Treatment Period

Outcome Measure Data

Analysis Population Description

Only those subjects from the Intention-To-Treat (ITT) population who are PASI75 responder at Week 12 are included in the analysis of this variable.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	4	44	48
Median (95% Confidence Interval); Unit of Measure: weeks
	NA [1]; (NA to NA)	22.14; (17.00 to 26.00)	20.14; (17.00 to 22.29)

[1]

This parameter applied only to those subjects who had achieved PASI75 at the end of the treatment period and who had an event of relapse.

6. Secondary Outcome

Title	Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12
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 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population consisting of all randomized subjects.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	59	59	58
Measure Type: Number; Unit of Measure: percentage of subjects
	11.9	86.4	93.1

7. Secondary Outcome

Title	Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
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 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population consisting of all randomized subjects.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	59	59	58
Measure Type: Number; Unit of Measure: percentage of subjects
	1.7	39.0	46.6

8. Secondary Outcome

Title	Experience of a Rebound Effect Within 2 Months After Stopping Therapy
Description	Rebound is defined as worsening of psoriasis over baseline value with more than 125 % or new pustular, erythrodermic or more inflammatory psoriasis within 2 months of stopping therapy.
Time Frame	Within 2 months of stopping therapy

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population consisting of all randomized subjects.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	59	59	58
Measure Type: Number; Unit of Measure: percentage of subjects
	15.3	1.7	1.7

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT population consisting of all randomized subjects. The analysis was performed for week 12 using observed case data (i.e., no imputation was performed for missing data). By week 12, there were 29 patients who had prematurely discontinued the study.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	40	53	54
Mean (Standard Deviation); Unit of Measure: percentage of affected Body Surface Area
	28.8 (17.2)	7.1 (9.3)	5.6 (6.5)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT population consisting of all randomized subjects. The analysis was performed for week 12 using observed case data (i.e., no imputation was performed for missing data). By week 12, there were 29 patients who had prematurely discontinued the study.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	40	53	54
Mean (Standard Deviation); Unit of Measure: Percent of total Body surface area
	3.2 (11.9)	18.3 (15.1)	22.6 (15.7)

11. Secondary Outcome

Title	Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis
Description	[Not Specified]
Time Frame	During the 12-week Treatment Period

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population consisting of all randomized subjects.

Arm/Group Title	Placebo (ITT)	Certolizumab Pegol 200 mg (ITT)	Certolizumab Pegol 400 mg (ITT)
Arm/Group Description:	Subcutaneous injections of Placebo every 2 weeks	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	59	59	58
Median (Full Range); Unit of Measure: days
	42.0; (21.0 to 75.0)	59.5; (35.0 to 70.0)	49.0; (21.0 to 77.0)

Adverse Events

Time Frame	Adverse Events were collected from Baseline (Week 0) over the 12-weeks Treatment Period until the end of the Follow-up Period (up to 36 weeks).
Adverse Event Reporting Description	The safety population consisted of all subjects who were exposed to study medication. One subject in the PBO group received one injection of CDP870 200 mg on one occasion. In the safety analysis, this subject was considered to be in the 200 mg group. One subject in the 400 mg group was randomized by mistake but did not receive study medication. This subject discontinued from the study due to an adverse event. This subject was randomized and is part of the ITT population.
Arm/Group Title	Placebo (SS)	Certolizumab Pegol 200 mg (SS)	Certolizumab Pegol 400 mg (SS)
Arm/Group Description	Subcutaneous injections of Placebo every 2 weeks	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
	Placebo (SS)	Certolizumab Pegol 200 mg (SS)	Certolizumab Pegol 400 mg (SS)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/58 (0.00%)	0/60 (0.00%)	0/57 (0.00%)
Serious Adverse Events
	Placebo (SS)	Certolizumab Pegol 200 mg (SS)	Certolizumab Pegol 400 mg (SS)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/58 (1.72%)	2/60 (3.33%)	5/57 (8.77%)
Gastrointestinal disorders
Diarrhoea haemorrhagic * 1	1/58 (1.72%)	0/60 (0.00%)	0/57 (0.00%)
Infections and infestations
Disseminated tuberculosis * 1	0/58 (0.00%)	0/60 (0.00%)	1/57 (1.75%)
Gastroenteritis * 1	0/58 (0.00%)	1/60 (1.67%)	1/57 (1.75%)
Urinary tract infection * 1	0/58 (0.00%)	1/60 (1.67%)	0/57 (0.00%)
Injury, poisoning and procedural complications
Contusion * 1	0/58 (0.00%)	1/60 (1.67%)	0/57 (0.00%)
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	0/58 (0.00%)	0/60 (0.00%)	2/57 (3.51%)
Psychiatric disorders
Anxiety * 1	0/58 (0.00%)	0/60 (0.00%)	1/57 (1.75%)
Skin and subcutaneous tissue disorders
Psoriasis * 1	0/58 (0.00%)	0/60 (0.00%)	1/57 (1.75%)
1 Term from vocabulary, MedDRA; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo (SS)	Certolizumab Pegol 200 mg (SS)	Certolizumab Pegol 400 mg (SS)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	34/58 (58.62%)	32/60 (53.33%)	27/57 (47.37%)
Gastrointestinal disorders
Constipation * 1	3/58 (5.17%)	2/60 (3.33%)	1/57 (1.75%)
Diarrhoea * 1	1/58 (1.72%)	5/60 (8.33%)	1/57 (1.75%)
Dyspepsia * 1	2/58 (3.45%)	0/60 (0.00%)	3/57 (5.26%)
Nausea * 1	3/58 (5.17%)	1/60 (1.67%)	1/57 (1.75%)
General disorders
Asthenia * 1	3/58 (5.17%)	3/60 (5.00%)	3/57 (5.26%)
Chills * 1	3/58 (5.17%)	1/60 (1.67%)	1/57 (1.75%)
Fatigue * 1	0/58 (0.00%)	4/60 (6.67%)	0/57 (0.00%)
Injection site haematoma * 1	0/58 (0.00%)	4/60 (6.67%)	2/57 (3.51%)
Injection site irritation * 1	0/58 (0.00%)	3/60 (5.00%)	1/57 (1.75%)
Pyrexia * 1	3/58 (5.17%)	2/60 (3.33%)	4/57 (7.02%)
Infections and infestations
Bronchitis * 1	3/58 (5.17%)	0/60 (0.00%)	4/57 (7.02%)
Herpes simplex * 1	1/58 (1.72%)	4/60 (6.67%)	0/57 (0.00%)
Influenza * 1	4/58 (6.90%)	2/60 (3.33%)	2/57 (3.51%)
Nasopharyngitis * 1	10/58 (17.24%)	4/60 (6.67%)	12/57 (21.05%)
Rhinitis * 1	4/58 (6.90%)	1/60 (1.67%)	2/57 (3.51%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	2/58 (3.45%)	5/60 (8.33%)	3/57 (5.26%)
Back pain * 1	3/58 (5.17%)	5/60 (8.33%)	2/57 (3.51%)
Nervous system disorders
Headache * 1	9/58 (15.52%)	13/60 (21.67%)	8/57 (14.04%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	3/58 (5.17%)	5/60 (8.33%)	2/57 (3.51%)
Pharyngolaryngeal pain * 1	1/58 (1.72%)	1/60 (1.67%)	4/57 (7.02%)
Skin and subcutaneous tissue disorders
Pruritus * 1	4/58 (6.90%)	7/60 (11.67%)	4/57 (7.02%)
1 Term from vocabulary, MedDRA; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

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

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: +1844 599 ext 2273
• EMail: UCBCares@ucb.com

Publications of Results:

Ortonne JP, Tasset C, Reich K. Efficacy of certolizumab pegol, a PEGylated Fab' fragment of an anti-alpha monoclonal antibody, in patients previously exposed to biologicals: preliminary results of a randomised, placebo-controlled, phase II clinical trial in psoriasis. J.Eur.Acad.Dermatol.Venereol. 22[Suppl 1], 2007. Vienna, 16th Congress of the European Academy of Dermatology and Venereology (EADV), May 16-20, 2007.

Ortonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.

Reich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.

Ortonne JP, Sterry W, Tasset C, Reich K. Certolizumab pegol, the first pegylated anti-TNF alpha, is effective and well tolerated in patients with moderate-to-severe chronic plaque psoriasis: preliminary data from a phase II study. J.Eur.Acad.Dermatol.Venereol. 21[Suppl 1], 26. 2007. Rhodes, Greece, 15th Congress of the European Academy of Dermatology and Venereology (EADV), October 4-8, 2006.

Ortonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

Reich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

Ortonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

Ortonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

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

• ClinicalTrials.gov Identifier: NCT00245765
• Other Study ID Numbers: C87040; 2005-002141-39 ( EudraCT Number )
• First Submitted: October 26, 2005
• First Posted: October 28, 2005
• Results First Submitted: June 22, 2018
• Results First Posted: May 3, 2019
• Last Update Posted: May 3, 2019