Overview

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

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Pharma
Treatments:
Certolizumab Pegol
Criteria
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