Psoriasis MedDRA version: 8.1 Level: LLT Classification code 10037153
Conditions
Interventions
Product Name: CDP870
Product Code: CDP870
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Certolizumab pegol (rINN)
Current Sponsor code: CDP870
Other descriptive name: Anti TNF human
Sponsors
UCB Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, all of the following criteria must be met: •Subjects having responded to treatment at week 12 in study C87040 (having shown an improvement of = 75% from his/her baseline PASI) and having relapsed during the follow-up period (in the 24 weeks after the end of the study treatment). The relapse is defined as a reduction by more than 50% of the maximal improvement in PASI score from baseline during the treatment period) •Subject remaining able to understand the information provided to them and to give written informed consent for C87044; •Female subject either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence is not an acceptable method). Subjects must agree to continue to use adequate contraception during the study and for 12 weeks after the last dose of CDP870. •Subject having a social security system (applicable for France only) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must be excluded if they meet any of the following criteria: •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; •Severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease; •Hepatic or renal dysfunction measured by hepatic enzymes (AST and ALT) greater than three times the upper limit of normal or serum creatinine higher than 2 mg/100 ml; •Pregnancy; •Lactating female; •Active malignancy of any type; •White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter; •New York Heart Association (NYHA) class III-IV congestive heart failure; •Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis); •Systemic Lupus Erythematosus; •History of significant adverse reaction to biological products or polyethylene glycol; Tuberculosis positive defined as positive induration = 5 mm PPD skin test (subjects with a positive PPD skin test associated with previous vaccination where there is no clinical or radiographic suspicion of TB maybe enrolled at the discretion of the Investigator); •Participation in a clinical study within the past 3 months except study C87040 •Current or past intake of the following treatments with the here below specified wash out periods before visit 1. These treatments remain also forbidden during the whole trial period i.e. until final visit V9: Wash out period = 6 months -Infliximab -Adalimumab -Alefacept -Any other antipsoriatic biological agent under investigation other than CDP870 Wash out period = 3 months -Etanercept Wash out period = 2 months -Efalizumab Wash out period = 4 weeks -Systemic retinoids -Systemic immunosuppressants agents (eg: methotrexate, cyclosporine, azathioprine, thioguanine) -Systemic fumarate -Systemic corticosteroids -Phototherapy or photochemotherapy -High potency topical corticosteroids (class I and II) -Any other antipsoriatic agent under investigation Wash out period = 2 weeks -Moderate potency (class III to V) topical corticosteroids (except if applied on the scalp, palms, groin, anal fold and/or soles) -Vitamin D analogues and topical retinoïds (except if applied on the scalp, palms, groin, anal fold and/or soles) -Keratolitic and coal tar (except if applied on the scalp, palms, groin, anal fold and/or soles) •Subjects having experienced a rebound reaction in study C87040 •Poor compliance with visit schedule or medication intake in study C87040 •Any other condition, which in the Investigator’s judgment would make the subject unsuitable for inclusion in the study. If the investigator has any medically valid reason to doubt the eligibility of a subject, the subject should not be included into the trial. If, however, the Investigator has any other kind of doubts concerning the eligibility, he/she should consult the Sponsor Study Physician for clarification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess difference in PASI scores between week 12 score of the first study C87040 and week 12 score of re-treatment (study C87044). ;Secondary Objective: The efficacy objectives will be to describe: - the evolution of the response during re-treatment using PASI and PGA scales as well as BSA affected by psoriasis, - the time to discontinuation from re-treatment due to lack of efficacy - the best re-treatment effect - the evolution of Health-Related Quality of Life (HRQOL) The PK profile of CDP870 as well as the development of anti-CDP870 antibodies will be assessed. The safety /tolerance will be described. Efficacy, safety and PK data will be analyzed using the data from studies C87040 and C87044 for subjects having participated in both studies ;Primary end point(s): Primary efficacy variable Difference in PASI scores between week 12 score of the first study C87040 and week 12 score of re-treatment (study C87044). For patients with a missing PASI score at week 12 of re-treatment, his/her last PASI score under re-treatment will be used. Pharmacokinetic variables •Samples for the measurement of CDP870 and anti-CDP870 antibodies will be taken at baseline and monthly. Safety variables •Frequency, severity, nature and duration of adverse events reported by the subjects during the whole duration of the 2 studies (C87040 and C87044). •Physical examination abnormalities, evaluated monthly. •Vital signs parameters, evaluated monthly. •ECG parameters, evaluated during the first and the last visits of the re-treatment period. •Blood parameters (hematology, chemistry, CRP and hepatic enzymes), evaluated monthly during the study re-treatment period. •Urine test, evaluated monthly during the study re-treatment period . •Level of auto-antibodies, evaluated monthly during the study re-treatment period : •Level of anti-nuclear antibody (ANA), •Level of anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibody, •Level of | — |
Countries
Germany
Outcome results
None listed