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

UCB

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: Certolizumab Pegol (Cimzia®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00329303

C87044

2005-005525-63 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject having responded to treatment at Week 12 in study C87040 and having relapsed during the follow-up period
Female subjects either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception.Subjects agreed to continue using adequate contraception during the study and for 12 weeks after the last dose of CDP870

Exclusion criteria

Subjects with erythrodermic, guttate, generalized pustular form of psoriasis
Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
Positive hepatitis B surface antigen test and /or hepatitis C antibody test results
Positive human immunodeficiency virus (HIV) test result
White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter
Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
Systemic Lupus Erythematosus
Participation in a clinical study within the past 3 months except Study C87040
Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study