psoriasis MedDRA version: 8.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Trade Name: Humira
Product Name: Humira 40mg for injection in pre-filled syringe (adalimumab)
Product Code: NA
Pharmaceutical Form: Solution for injection
Other descriptive name: ADALIMUMAB
Concentrat
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Plaque-type psoriasis 2. Non-responders to etanercept (ref: 2.2 Trial design) 3. Male and female subjects >18 years of age 4. Subjects must not have live vaccination during the study period. 5. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion: a) Barrier methods (condoms or intrauterine device) b) Contraceptives (oral, parenteral, transdermal or implantable) starting from three months prior to study drug administration c) Vasectomized partner d) Total abstinence from sexual intercourse e) Must have a negative serum pregnancy test at Screening and Baseline. 6. Normal chest x-ray (posterior–anterior and lateral) within 3 months prior to screening with no evidence of malignancy, infection or fibrosis. 7. Subject must meet the tuberculosis (TB) eligibility assessment and screening requirement according to current British Association of Dermatologists guidelines. 8. Subject is judged to be in good general health, as determined by investigator, based upon the results of a medical history, laboratory evaluations and the physical examination performed at screening and/or baseline. 9. Ability and willingness to self-administer subcutaneous injections or have available qualified person(s) to administer subcutaneous injections 10. Ability and willingness to give written informed consent or assent and to comply with the requirements of the protocol. 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: 1. Subject has erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis. 2. Subject has a poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischaemic heart disease, congestive heart failure, cardiomyopathy, significant renal or hepatic disease, depression of such severity that the subject is a suicide risk or any other condition, which, in the opinion of the investigator, would put the subject at risk by participation in the study 3. History of clinically significant drug or alcohol abuse within the last year 4. History of iv drug abuse 5. Pregnant or breast-feeding female 6. History of lupus-like illness, neurologic symptoms suggestive of central nervous system (CNS) demyelinating diseases or blood dyscrasias 7. Any other active skin disease or condition (e.g. bacterial, fungal or viral infection) that may interfere with assessment of psoriasis8. Subject receives or requires: a. UVB phototherapy, excessive sun exposure or the use of tanning booths for < 14 days prior to Baseline visit and during the study b. PUVA phototherapy < 2 weeks prior to baseline visit and throughout the study c. Systemic non-biologic therapies for psoriasis < 4 weeks prior to baseline visit and throughout the study. d. Investigational chemical agents must be discontinued at least 12 weeks or 5 half-lives prior to the baseline visit (whichever is longer) e. Oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed. 9. History of any malignancy within the past 5 years, except successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in-situ of the cervix. 10. History of active infection with Listeria or TB 11. Any ongoing chronic or active infection or any episode of infection requiring hospitalization, treatment with iv antibiotics or antivirals within 30 days or oral antibiotics, antifungals or antivirals within 14 days prior to Screening 12. Chronic hepatitis B requiring the current use of antiviral treatment, including antiretrovirals 13. Chronic hepatitis C 14. Known positive human immunodeficiency virus (HIV) status 15. History of congenital immunodeficiencies 16. Immune deficiency or immunocompromised 17. Inability to comply with the study procedures or requirements 18. Subject has a history of an allergic reaction or significant sensitivity to constituents of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to test the hypothesis that psoriasis patients who are non-responders to etanercept achieve a clinically useful response with adalimumab.;Secondary Objective: ;Primary end point(s): PASI 50 improvement at week 12 of adalimumab therapy; that is 50% improvement in Psoriasis Area and Severity Index (PASI) in relative to start of etanercept. Secondarily we will assess 75% improvement in PASI at week 12 adalimumab therapy and mean percentage of PASI improvement relative to start of etanercept and relative to start of adalimumab. | — |
Countries
United Kingdom
Outcome results
None listed