Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00245765

Purpose

A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

Condition	Intervention	Phase
Chronic Plaque Psoriasis	Drug: CDP870 (Certolizumab pegol)	Phase II

MedlinePlus related topics: Psoriasis

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-Severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy

Further study details as provided by UCB:

Primary Outcome Measures:

Proportion of subjects achieving PASI75 and rating PGA "clear" or "almost clear" at the end of 12 weeks treatment period

Secondary Outcome Measures:

to assess the safety and tolerability of the different dose regimens of CDP870 administered subcutaneously for 12 weeks versus placebo
to assess the efficacy of the different dose regimens of CDP870 administered subcutaneously for 12 weeks versus placebo as measured by:
the time to onset of action,
the time to relapse after the 12 week treatment
period
the proportion of subjects experiencing rebound
during the 2 first months of follow-up
the change from baseline in the body surface area
(BSA) affected by psoriasis at the end of the 12
week treatment period
the proportion of subjects achieving PASI90 and
PASI50 at the end of the 12 week treatment period.
the time to discontinuation from treatment period
due to lack of efficacy
the PK profile of CDP870 and the apparition of anti
CDP870 antibodies

Enrollment:	176
Study Start Date:	October 2005
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

men and women > 18 years;
Chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months;
PASI ≥ 12 and BSA ≥ 10%;
Candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy;

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: NCT00245765

Locations

France

Nice Cedex 3, France

Creteil, France

Saint-Etienne, France

Pierre Benite, France

Besancon, France

Paris, France
Germany

Berlin, Germany

Mainz, Germany

Bonn, Germany

Essen, Germany

Frankfurt, Germany

Munster, Germany

Kiel, Germany

Göttingen, Germany

Hamburg, Germany

Sponsors and Collaborators

UCB

Investigators

Study Director:

Anne CHIBOIS

UCB

More Information

Publications of Results:

Ortonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.

Reich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.

Ortonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

Reich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.

Ortonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

Ortonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.

Study ID Numbers:	C87040, EudraCT 2005-002141-39
Study First Received:	October 26, 2005
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00245765
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut

Keywords provided by UCB:

chronic plaque psoriasis, anti TNFα
CDP870, Cimzia

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 16, 2009