Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis
Follow-up of Study C87040: Multicentre, Double-blind Study to Describe the Efficacy and Safety of Re-treatment With CDP870 (Certolizumab Pegol) Subcutaneous at 2 Different Dose Regimens (400 mg Initial Dose at Week 0 With 200 mg Every 2 Weeks Thereafter and 400 mg Every 2 Weeks) or Placebo for 12 Weeks, in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy, Having Responded to Treatment in Study C87040 and Having Subsequently Relapsed
2 other identifiers
interventional
71
2 countries
14
Brief Summary
The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 \[NCT00245765\] and Week 12 of re-treatment in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2006
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedResults Posted
Study results publicly available
May 6, 2019
CompletedMay 6, 2019
February 1, 2019
1.1 years
May 22, 2006
June 22, 2018
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. The difference was calculated by 'PASI score at re-treatment Week 12' minus 'PASI score at First Treatment Week 12'.
Week 12 in C87040 [NCT00245765] and Week 12 in this study
Secondary Outcomes (77)
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Week 12
- +72 more secondary outcomes
Study Arms (2)
Certolizumab Pegol (CZP) 200 mg
EXPERIMENTALSubcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter.
Certolizumab Pegol (CZP) 400 mg
EXPERIMENTALSubcutaneous injections of 400 mg every 2 weeks.
Interventions
* Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use * Dose and Administration details : 2 x 1 mL Certolizumab Pegol at Week 0, followed by * 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10 * 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10
Eligibility Criteria
You may qualify if:
- Subject having responded to treatment at Week 12 in study C87040 and having relapsed during the follow-up period
- Female subjects either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception.Subjects agreed to continue using adequate contraception during the study and for 12 weeks after the last dose of CDP870
You may not qualify if:
- Subjects with erythrodermic, guttate, generalized pustular form of psoriasis
- Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
- Positive hepatitis B surface antigen test and /or hepatitis C antibody test results
- Positive human immunodeficiency virus (HIV) test result
- White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter
- Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- Systemic Lupus Erythematosus
- Participation in a clinical study within the past 3 months except Study C87040
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (14)
Unknown Facility
Besançon, France
Unknown Facility
Créteil, France
Unknown Facility
Nice, France
Unknown Facility
Paris, France
Unknown Facility
Pierre-Bénite, France
Unknown Facility
Berlin, Germany
Unknown Facility
Bonn, Germany
Unknown Facility
Essen, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Mahlow, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
Münster, Germany
Related Publications (1)
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.
PMID: 22413944RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
UCB Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
April 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
May 6, 2019
Results First Posted
May 6, 2019
Record last verified: 2019-02