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Trial record 1 of 2 for:    NCT00245765
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Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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)
Hide 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.
Arm/Group Title Placebo (ITT) Certolizumab Pegol 200 mg (ITT) Certolizumab Pegol 400 mg (ITT) Total Title
Hide 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
Hide 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%
1.Primary Outcome
Title Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12
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 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %.

Time Frame Week 12
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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.
Hide 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
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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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]
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
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 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %.

Time Frame Week 12
Hide Outcome Measure Data
Hide 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)
Hide 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
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 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %.

Time Frame Week 12
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
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
Hide Outcome Measure Data
Hide 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)
Hide 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
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 Baseline up to Week 12
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide Description [Not Specified]
Time Frame During the 12-week Treatment Period
Hide Outcome Measure Data
Hide 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)
Hide 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)
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)
Hide 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%) 
Hide 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
Hide 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
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: +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.
Layout table for additonal information
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