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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329303
First Posted: May 24, 2006
Last Update Posted: September 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UCB Pharma
  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
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 Pharma:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00329303     History of Changes
Other Study ID Numbers: C87044
EudraCT 2005 - 005525 - 63
First Submitted: May 22, 2006
First Posted: May 24, 2006
Last Update Posted: September 9, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
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
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents