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临床试验/NCT00329303
NCT00329303已完成2 期

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

UCB Pharma0 个研究点目标入组 71 人开始时间: 2006年4月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
UCB Pharma
入组人数
71
主要终点
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
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Certolizumab Pegol (CZP) 200 mg

Experimental

Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter.

干预措施: Certolizumab Pegol (Cimzia®) (Drug)

Certolizumab Pegol (CZP) 400 mg

Experimental

Subcutaneous injections of 400 mg every 2 weeks.

干预措施: Certolizumab Pegol (Cimzia®) (Drug)

结局指标

主要结局

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

时间窗: Week 12 in C87040 [NCT00245765] and Week 12 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'.

次要结局

  • Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040(Week 3 of first treatment Period in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study(Week 2 of re-treatment Period in this study)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study(Week 4 of re-treatment Period in this study)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study(Week 10 of re-treatment Period in this study)
  • 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(From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040)
  • 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(From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040)
  • 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)
  • Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study(Week 12)
  • Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040(First treatment Baseline in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040(Week 1 of first treatment Period in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040(Week 2 of first treatment Period in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040(Week 10 of first treatment Period in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study(Week 8 of re-treatment Period in this study)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040(Week 4 of first treatment Period in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040(Week 6 of first treatment Period in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040(Week 8 of first treatment Period in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040(Week 12 of first treatment Period in study C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study(Re-treatment Baseline in this study)
  • Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study(From first treatment Baseline in study C87040 to re-treatment Baseline in this study)
  • 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(From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study)
  • 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(From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study(Week 6 of re-treatment Period in this study)
  • Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study(Week 12 of re-treatment Period in this study)
  • 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(From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040)
  • Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study(Last re-treatment visit in this study)
  • 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(From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040)
  • 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(From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040)
  • 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(From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040)
  • 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(From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040)
  • 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(From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040)
  • 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(From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study)
  • 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(From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study)
  • 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(From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study)
  • 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(From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study)
  • Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study(12 week re-treatment Period in this study)
  • 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(From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study)
  • 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(From re-treatment Baseline in this study to Week 12 of re-treatment in this study)
  • Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040(12 week first treatment Period in study C87040)
  • Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040(12 week first treatment Period in study C87040)
  • Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study(12 week re-treatment Period in this study)
  • Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study(Re-treatment Baseline in this study)
  • Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study(Week 2 of re-treatment Period in this study)
  • Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study(Week 4 of re-treatment Period in this study)
  • Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study(Week 6 of re-treatment Period in this study)
  • Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study(Week 8 of re-treatment Period in this study)
  • Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study(Week 10 of re-treatment Period in this study)
  • Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study(Week 12 of re-treatment Period in this study)
  • Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study(Last re-treatment visit in this study)
  • BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study(Week 6 of re-treatment Period in this study)
  • Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study(Week 12 of re-treatment in this study)
  • Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study(From first treatment Baseline in C87040 to re-treatment Baseline in this study)
  • Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study(From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study)
  • BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study(Re-treatment Baseline in this study)
  • BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study(Week 4 of re-treatment Period in this study)
  • BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study(Last re-treatment visit in this study)
  • BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study(Week 2 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study(From re-treatment Baseline in this study to last re-treatment visit in this study)
  • BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study(Week 8 of re-treatment Period in this study)
  • BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study(Week 10 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study(From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study)
  • BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study(Week 12 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study(From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study(From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study(From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study(From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study(From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study(From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study)
  • Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study(From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study(From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study(From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study(From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study)
  • Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study(From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study)
  • 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(During the 12 week re-treatment Period in this study)

研究者

发起方
UCB Pharma
申办方类型
Industry
责任方
Sponsor

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