Efficacy of re-Treatment With Cimzia® in Subject With Chronic Plaque Psoriasis - Full Text View

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 II

MedlinePlus related topics:

Psoriasis

ChemIDplus related topics:

Certolizumab pegol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment

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

Further study details as provided by UCB:

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

	Nice Cedex 3, France

	Créteil, France

	Paris, France

	Besançon, France

	Pierre Benite, France

Germany

	Kiel, Germany

	Mainz, Germany

	Munster, Germany

	Berlin, Germany

	Hamburg, Germany

	Bonn, Germany

	Essen, Germany

	Frankfurt, Germany

	Mahlow, Germany

Sponsors and Collaborators

UCB

Investigators


Study Director:	Chantal Tasset, Ph.D.	UCB

More Information

Study ID Numbers:	C87044, EudraCT 2005 - 005525 - 63
First Received:	May 22, 2006
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00329303
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by UCB:

Moderate to severe chronic plaque psoriasis

anti TNF α

CDP 870

Cimzia®

certolizumab pegol

retreatment

Study placed in the following topic categories:

Skin Diseases

Psoriasis

Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00329303