Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00329303
First received: May 22, 2006
Last updated: September 6, 2013
Last verified: September 2009
  Purpose

The primary objective is to assess the effect of re-treatment after relapse in subjects with moderate to severe chronic plaque psoriasis having responded to a first treatment.


Condition Intervention Phase
Psoriasis
Drug: Certolizumab pegol (cimzia®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Re-treatment With Cimzia® at 2 Dose Regimens for 12 Weeks in Subject Suffering From Moderate to Severe Chronic Plaque Psoriasis Having Relapsed After Response to First Treatment

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • To assess the efficacy of re-treatment with cimzia® compared to first treatment in patients having relapsed after response to first treatment.

Secondary Outcome Measures:
  • To describe safety of re-treatment.

Estimated Enrollment: 75
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject having responded to treatment in study C87040 and having relapsed during the follow-up period.

Exclusion Criteria:

  • 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/mm3 or more than 20000/mm3;
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329303

Locations
France
Besançon, France
Créteil, France
Nice Cedex 3, France
Paris, France
Pierre Benite, France
Germany
Berlin, Germany
Bonn, Germany
Essen, Germany
Frankfurt, Germany
Hamburg, Germany
Kiel, Germany
Mahlow, Germany
Mainz, Germany
Munster, Germany
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00329303     History of Changes
Other Study ID Numbers: C87044, EudraCT 2005 - 005525 - 63
Study First Received: May 22, 2006
Last Updated: September 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UCB, Inc.:
Moderate to severe chronic plaque psoriasis
anti TNF α
CDP 870
Cimzia®
certolizumab pegol
retreatment

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014