Trial Outcomes & Findings for Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy (NCT NCT00245765)

Last Updated: 2019-05-03

Results Overview

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 %.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

176 participants

Primary outcome timeframe

Week 12

Results posted on

2019-05-03

Participant Flow

The study started to enroll patients in October 2005 and concluded in November 2006.

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.

Participant milestones

Participant milestones
Measure	Placebo (ITT) Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) Subcutaneous injections of 400 mg every 2 weeks
Overall Study STARTED	59	59	58
Overall Study Safety Population	58	60	57
Overall Study COMPLETED	27	45	50
Overall Study NOT COMPLETED	32	14	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (ITT) Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) Subcutaneous injections of 400 mg every 2 weeks
Overall Study Adverse Event	1	1	0
Overall Study Lack of Efficacy	14	7	0
Overall Study Lost to Follow-up	1	2	0
Overall Study Withdrawal by Subject	1	0	3
Overall Study Other reason	2	0	1
Overall Study Other	13	4	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (ITT) n=59 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=59 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=58 Participants Subcutaneous injections of 400 mg every 2 weeks	Total Title n=176 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	57 Participants n=7 Participants	55 Participants n=5 Participants	166 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Age, Continuous	43.30 years STANDARD_DEVIATION 12.78 • n=5 Participants	43.26 years STANDARD_DEVIATION 10.12 • n=7 Participants	43.64 years STANDARD_DEVIATION 12.36 • n=5 Participants	43.40 years STANDARD_DEVIATION 11.74 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	53 Participants n=4 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	44 Participants n=7 Participants	42 Participants n=5 Participants	123 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12

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

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=59 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=59 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=58 Participants Subcutaneous injections of 400 mg every 2 weeks
Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12	6.8 percentage of subjects	74.6 percentage of subjects	82.8 percentage of subjects

PRIMARY outcome

Timeframe: Week 12

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

The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=59 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=59 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=58 Participants Subcutaneous injections of 400 mg every 2 weeks
Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12	1.7 percentage of subjects	52.5 percentage of subjects	72.4 percentage of subjects

SECONDARY outcome

Timeframe: During the 12-weeks Treatment Period

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=4 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=44 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=48 Participants Subcutaneous injections of 400 mg every 2 weeks
Time to Psoriasis Activity and Severity Index 50 (PASI50)	56.50 days Interval 14.0 to 99.0	21.00 days Interval 20.0 to 28.0	22.00 days Interval 21.0 to 30.0

SECONDARY outcome

Timeframe: During the 12-weeks Treatment Period

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=4 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=44 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=48 Participants Subcutaneous injections of 400 mg every 2 weeks
Time to Psoriasis Activity and Severity Index 75 (PASI75)	77.50 days Interval 42.0 to 99.0	42.50 days Interval 28.0 to 56.0	55.50 days Interval 42.0 to 69.0

SECONDARY outcome

Timeframe: During the 12-weeks Treatment Period

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=4 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=44 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=48 Participants Subcutaneous injections of 400 mg every 2 weeks
Time to Relapse	NA weeks 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.	22.14 weeks Interval 17.0 to 26.0	20.14 weeks Interval 17.0 to 22.29

SECONDARY outcome

Timeframe: Week 12

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

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 %.

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=59 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=59 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=58 Participants Subcutaneous injections of 400 mg every 2 weeks
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12	11.9 percentage of subjects	86.4 percentage of subjects	93.1 percentage of subjects

SECONDARY outcome

Timeframe: Week 12

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

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 %.

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=59 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=59 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=58 Participants Subcutaneous injections of 400 mg every 2 weeks
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12	1.7 percentage of subjects	39.0 percentage of subjects	46.6 percentage of subjects

SECONDARY outcome

Timeframe: Within 2 months of stopping therapy

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

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.

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=59 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=59 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=58 Participants Subcutaneous injections of 400 mg every 2 weeks
Experience of a Rebound Effect Within 2 Months After Stopping Therapy	15.3 percentage of subjects	1.7 percentage of subjects	1.7 percentage of subjects

SECONDARY outcome

Timeframe: Week 12

Population: 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.

Two methods were used for the evaluation of BSA: 1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis 2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=40 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=53 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=54 Participants Subcutaneous injections of 400 mg every 2 weeks
Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12	28.8 percentage of affected Body Surface Area Standard Deviation 17.2	7.1 percentage of affected Body Surface Area Standard Deviation 9.3	5.6 percentage of affected Body Surface Area Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline up to Week 12

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=40 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=53 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=54 Participants Subcutaneous injections of 400 mg every 2 weeks
Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12	3.2 Percent of total Body surface area Standard Deviation 11.9	18.3 Percent of total Body surface area Standard Deviation 15.1	22.6 Percent of total Body surface area Standard Deviation 15.7

SECONDARY outcome

Timeframe: During the 12-week Treatment Period

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

Outcome measures

Outcome measures
Measure	Placebo (ITT) n=59 Participants Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (ITT) n=59 Participants Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (ITT) n=58 Participants Subcutaneous injections of 400 mg every 2 weeks
Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis	42.0 days Interval 21.0 to 75.0	59.5 days Interval 35.0 to 70.0	49.0 days Interval 21.0 to 77.0

Adverse Events

Placebo (SS)

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Certolizumab Pegol 200 mg (SS)

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Certolizumab Pegol 400 mg (SS)

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (SS) n=58 participants at risk Subcutaneous injections of Placebo every 2 weeks	Certolizumab Pegol 200 mg (SS) n=60 participants at risk Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter	Certolizumab Pegol 400 mg (SS) n=57 participants at risk Subcutaneous injections of 400 mg every 2 weeks
Gastrointestinal disorders Diarrhoea haemorrhagic	1.7% 1/58 • 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). 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.	0.00% 0/60 • 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). 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.	0.00% 0/57 • 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). 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.
Infections and infestations Disseminated tuberculosis	0.00% 0/58 • 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). 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.	0.00% 0/60 • 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). 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.	1.8% 1/57 • 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). 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.
Infections and infestations Gastroenteritis	0.00% 0/58 • 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). 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.	1.7% 1/60 • 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). 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.	1.8% 1/57 • 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). 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.
Infections and infestations Urinary tract infection	0.00% 0/58 • 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). 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.	1.7% 1/60 • 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). 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.	0.00% 0/57 • 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). 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.
Injury, poisoning and procedural complications Contusion	0.00% 0/58 • 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). 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.	1.7% 1/60 • 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). 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.	0.00% 0/57 • 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). 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.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/58 • 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). 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.	0.00% 0/60 • 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). 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.	3.5% 2/57 • 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). 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.
Psychiatric disorders Anxiety	0.00% 0/58 • 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). 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.	0.00% 0/60 • 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). 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.	1.8% 1/57 • 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). 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.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/58 • 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). 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.	0.00% 0/60 • 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). 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.	1.8% 1/57 • 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). 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.

Other adverse events

Additional Information

UCB

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Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60