A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
176
* Pharmaceutical Form: solution for injection in pre-filled syringe * Route of Administration: subcutaneous use
Matching Placebo to Certolizumab Pegol
Unnamed facility
Besançon, France
Unnamed facility
Créteil, France
Unnamed facility
Nice, France
Unnamed facility
Paris, France
Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12
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
Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12
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
Time to Psoriasis Activity and Severity Index 50 (PASI50)
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
Time to Psoriasis Activity and Severity Index 75 (PASI75)
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
Time to Relapse
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Unnamed facility
Pierre-Bénite, France
Unnamed facility
Saint-Etienne, France
Unnamed facility
Berlin, Germany
Unnamed facility
Bonn, Germany
Unnamed facility
Essen, Germany
Unnamed facility
Frankfurt, Germany
...and 5 more locations
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
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12
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
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
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
Experience of a Rebound Effect Within 2 Months After Stopping Therapy
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
Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12
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
Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12
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
Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis
Time frame: During the 12-week Treatment Period