Clinical Trials Directory

Trials / Completed

CompletedNCT00329303

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
71 (actual)
Sponsor
UCB Pharma · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCertolizumab Pegol (Cimzia®)* 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

Timeline

Start date
2006-04-01
Primary completion
2007-05-01
Completion
2007-05-01
First posted
2006-05-24
Last updated
2019-05-06
Results posted
2019-05-06

Locations

14 sites across 2 countries: France, Germany

Source: ClinicalTrials.gov record NCT00329303. Inclusion in this directory is not an endorsement.