Patients with psoriasis vulgaris (plaque psoriasis)
Conditions
Interventions
Product Name: adalimumab/HUMIRA
Pharmaceutical Form: Solution for injection
Sponsors
Knud Kragballe, Dermatological Department, Århus Sygehus (Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female more than or equal to 18 years of age Diagnosis of plaque psoriasis according to the Investigator Moderate or severe psoriasis according to the PGA (PGA more than or equal to 4, i.e. classified as moderate, moderate to severe, or severe) Having a PASI more than or equal to 10 and BSA more than or equal to 10, and being eligible to biological anti-psoriatic therapy in the opinion of the investigator A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment. [Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)] Use of reliable method of contraception e.g. intra-uterine devices or hormone contraceptives (oral, implantable, or injectable) by all female patients of childbearing potential during the entire study and 150 days after cessation of study medication. Able and willing to self-administer s.c. injections or have available a suitable person to administer s.c. injections. Able and willing to give written informed consent/power of attorney and to comply with the requirements of the study 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: Use of topical anti-psoriatic therapy, e.g. topical vitamin D derivatives or topical corticosteroids, and UVB therapy 2 weeks prior to screening and during the 12 weeks’ treatment phase Use of psoralen ultraviolet A therapy (PUVA) or systemic corticosteroids 4 weeks prior to screening and during the 12 weeks’ treatment phase Use of biological therapies, e.g. efalizumab, etanercept, or infliximab, 12 weeks prior to screening and during the 12 weeks’ treatment phase Systemic therapies known to exacerbate psoriaisis, e.g. B-blocking agents, lithium, or chloroquines, during the study Positive serology for hepatitis B or C indicating active infection Immuno-compromised conditions or history of HIV. History of listeriosis, history of histoplasmosis, active tuberculosis (TB), persistent chronic or active infections requiring hospitalisation and/or treatment with intravenous (i.v.) antibiotics, i.v. antivirals, or i.v. antifungals within 30 days or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to screening. Subjects with latent TB (positive purified protein derivative (PPD) skin test and/or chest X-ray indicative for TB) History of malignant melanoma History of malignancy within the previous 5 years, other than malignant melanoma or a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, and/or localized carcinoma in situ of the cervix. Poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the study. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. There should be at least a 150 days’ period between the last dose of study drug and either conception or initiation of breast-feeding in women of childbearing potential. History of clinically significant drug or alcohol abuse in the last year History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease Investigational biological and chemical agents within 6 months prior to screening. Allergy to investigational product or its contents or latex (found in the protective cover of the syringe needle). The investigator considers the subject, for any reason, to be unacceptable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to determine if P-38, MK2, MSK-1 levels and TNF-a in lesional psoriatic skin are normalized by Adalimumab;Secondary Objective: Secondary objectives are to investigate if changes in inflammatory cytokine levels and TNF-a will be correlated with clinical response (PASI 75, success according to PGA).;Primary end point(s): Proportion of patients achieving normalized TNF-a, P-38, MK2, and MSK1 levels in psoriatic skin lesions, based on skin biopsies taken at day 84 | — |
Countries
Denmark
Outcome results
None listed