Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
- Conditions
- Chronic Plaque Psoriasis
- Interventions
- Other: Placebo
- Registration Number
- NCT00245765
- Lead Sponsor
- UCB Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- Adult men and women > 18 years
- Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
- Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %
- Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
- Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
- A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);
- White blood cell counts less than 4000/mm^3 or more than 20000/mm^3
- Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- Systemic Lupus
- Non respect of adequate wash out periods for treatments that might have an impact on the disease
- Any associated disease that could be impacted by the study treatment intake
- Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subcutaneous injections of Placebo every 2 weeks Certolizumab Pegol 400 mg Certolizumab Pegol Subcutaneous injections of 400 mg every 2 weeks Certolizumab Pegol 200 mg Certolizumab Pegol Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
- Primary Outcome Measures
Name Time Method Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12 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)Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12 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 %.
- Secondary Outcome Measures
Name Time Method Time to Psoriasis Activity and Severity Index 50 (PASI50) During the 12-weeks Treatment Period 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).Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 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 to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis During the 12-week Treatment Period Time to Psoriasis Activity and Severity Index 75 (PASI75) During the 12-weeks Treatment Period 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).Experience of a Rebound Effect Within 2 Months After Stopping Therapy Within 2 months of 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.
Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12 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 to Relapse During the 12-weeks Treatment Period 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).
Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12 Baseline up to 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.Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 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 %.