Back to resultsEfficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
Primary Purpose
Chronic Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring chronic plaque psoriasis, anti TNFα, CDP870, Cimzia
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Certolizumab Pegol 200 mg
Certolizumab Pegol 400 mg
Arm 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
Outcomes
Primary Outcome Measures
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 %.
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)
Secondary Outcome Measures
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 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 to Relapse
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).
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 %.
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 %.
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.
Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12
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 %)
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:
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 to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00245765
Brief Title
Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
Official Title
Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
chronic plaque psoriasis, anti TNFα, CDP870, Cimzia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous injections of Placebo every 2 weeks
Arm Title
Certolizumab Pegol 200 mg
Arm Type
Experimental
Arm Description
Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Arm Title
Certolizumab Pegol 400 mg
Arm Type
Experimental
Arm Description
Subcutaneous injections of 400 mg every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Certolizumab Pegol
Other Intervention Name(s)
Cimzia
Intervention Description
Pharmaceutical Form: solution for injection in pre-filled syringe
Route of Administration: subcutaneous use
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo to Certolizumab Pegol
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
Title
Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis
Time Frame
During the 12-week Treatment Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
City
Besancon
Country
France
City
Creteil
Country
France
City
Nice Cedex 3
Country
France
City
Paris
Country
France
City
Pierre Benite
Country
France
City
Saint-Etienne
Country
France
City
Berlin
Country
Germany
City
Bonn
Country
Germany
City
Essen
Country
Germany
City
Frankfurt
Country
Germany
City
Göttingen
Country
Germany
City
Hamburg
Country
Germany
City
Kiel
Country
Germany
City
Mainz
Country
Germany
City
Munster
Country
Germany
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
22413944
Citation
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.
Results Reference
result
Learn more about this trial
Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
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