Clinical trial NCT00329303: Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Moderate to severe chronic plaque psoriasis
anti TNF α
CDP 870
Cimzia®
certolizumab pegol
retreatment
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study

Primary outcomes:
measure: 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
timeFrame: Week 12 in C87040 [NCT00245765] and Week 12 in this study
Secondary outcomes:
measure: Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
timeFrame: Week 12
measure: Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
timeFrame: Week 12
measure: Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
timeFrame: Week 12
measure: Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
timeFrame: Week 12
measure: Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
timeFrame: Week 12
measure: Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
timeFrame: Week 12
measure: Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040
timeFrame: First treatment Baseline in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040
timeFrame: Week 1 of first treatment Period in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040
timeFrame: Week 2 of first treatment Period in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040
timeFrame: Week 3 of first treatment Period in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040
timeFrame: Week 4 of first treatment Period in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040
timeFrame: Week 6 of first treatment Period in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040
timeFrame: Week 8 of first treatment Period in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040
timeFrame: Week 10 of first treatment Period in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040
timeFrame: Week 12 of first treatment Period in study C87040
measure: Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study
timeFrame: Re-treatment Baseline in this study
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study
timeFrame: Week 2 of re-treatment Period in this study
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study
timeFrame: Week 4 of re-treatment Period in this study
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study
timeFrame: Week 6 of re-treatment Period in this study
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study
timeFrame: Week 8 of re-treatment Period in this study
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study
timeFrame: Week 10 of re-treatment Period in this study
measure: Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study
timeFrame: Week 12 of re-treatment Period in this study
measure: Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study
timeFrame: Last re-treatment visit in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 1 of First Treatment Period in C87040
timeFrame: From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of First Treatment Period in C87040
timeFrame: From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 3 of First Treatment Period in C87040
timeFrame: From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of First Treatment Period in C87040
timeFrame: From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of First Treatment Period in C87040
timeFrame: From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of First Treatment Period in C87040
timeFrame: From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of First Treatment Period in C87040
timeFrame: From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of First Treatment Period in C87040
timeFrame: From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study
timeFrame: From first treatment Baseline in study C87040 to re-treatment Baseline in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Last Re-treatment Visit in This Study
timeFrame: From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study
measure: Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment in This Study
timeFrame: From re-treatment Baseline in this study to Week 12 of re-treatment in this study
measure: Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040
timeFrame: 12 week first treatment Period in study C87040
measure: Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study
timeFrame: 12 week re-treatment Period in this study
measure: Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040
timeFrame: 12 week first treatment Period in study C87040
measure: Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study
timeFrame: 12 week re-treatment Period in this study
measure: Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study
timeFrame: Re-treatment Baseline in this study
measure: Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study
timeFrame: Week 2 of re-treatment Period in this study
measure: Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study
timeFrame: Week 4 of re-treatment Period in this study
measure: Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study
timeFrame: Week 6 of re-treatment Period in this study
measure: Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study
timeFrame: Week 8 of re-treatment Period in this study
measure: Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study
timeFrame: Week 10 of re-treatment Period in this study
measure: Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study
timeFrame: Week 12 of re-treatment Period in this study
measure: Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study
timeFrame: Last re-treatment visit in this study
measure: Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study
timeFrame: Week 12 of re-treatment in this study
measure: BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study
timeFrame: Re-treatment Baseline in this study
measure: BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study
timeFrame: Week 2 of re-treatment Period in this study
measure: BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study
timeFrame: Week 4 of re-treatment Period in this study
measure: BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study
timeFrame: Week 6 of re-treatment Period in this study
measure: BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study
timeFrame: Week 8 of re-treatment Period in this study
measure: BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study
timeFrame: Week 10 of re-treatment Period in this study
measure: BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study
timeFrame: Week 12 of re-treatment Period in this study
measure: BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study
timeFrame: Last re-treatment visit in this study
measure: Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study
timeFrame: From first treatment Baseline in C87040 to re-treatment Baseline in this study
measure: Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study
timeFrame: From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study
timeFrame: From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study
measure: Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study
timeFrame: From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study
timeFrame: From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study
timeFrame: From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study
timeFrame: From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study
timeFrame: From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study
timeFrame: From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study
measure: Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study
timeFrame: From re-treatment Baseline in this study to last re-treatment visit in this study
measure: Time to Withdrawal From the Treatment Due to Lack of Efficacy or Due to AE ('Worsening or Exacerbation of Psoriasis') During the 12 Week Re-treatment Period in This Study
timeFrame: During the 12 week re-treatment Period in this study
Other outcomes:
Locations:
city: Besançon
country: France
city: Créteil
country: France
city: Nice Cedex 3
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Kiel
country: Germany
city: Mahlow
country: Germany
city: Mainz
country: Germany
city: Munster
country: Germany
Study officials:
affiliation: UCB Pharma
name: UCB Cares
role: STUDY_DIRECTOR
References:
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.