Psoriasis Disease
Conditions
Interventions
Trade Name: Adalimumab
Product Name: Humira
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 80-
Phar
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects 18 years of age or older who have a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis, as defined by >10% BSA involvement and PASI score >10 at the Baseline (Week 0) visit.Other main inclusion criteria include: Candidate for systemic therapy or photo-therapy and has active psoriasis despite treatment with topical agents. An evaluation for latent tuberculosis infection with a purified protein derivative test (PPD) and CXR. Subjects who have evidence of latent TB infection may participate in the study provided that prophylactic treatment begins before study drug is administered. Women of child bearing potential must have a negative pregnancy test at Screening and Baseline and practice an adequate method of contraception during and for at least 150 days after study completion. Women must be non-lactating and non-breastfeeding. Men must practice an adequate method of contraception during and for at least 90 days after study completion. 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria include; Previous systemic anti-TNF therapy. Previous methotrexate therapy. Known history of allergic reaction or significant hypersensitivity to the constituents of either adalimumab, methotrexate, or placebo. Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies which must be discontinued at least 12 weeks prior to enrollment. Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only. Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline. Use of PUVA for at least 4 weeks prior to Baseline. Use of oral or injectable corticosteroids during the study. Other active skin diseases or skin infections (bacterial, viral, or fungal) that may interfere with evaluation of psoriasis. History of listeriosis, histoplasmosis, untreated TB, persistent chronic infections. Recent active infections requiring hospitalization or treatment with intravenous (iv) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit. Immune deficiency, history of HIV or is immunocompromised· Positive Hepatitis B or C (previous infection) Use of anti-retroviral therapy.History of neurologic symptoms suggestive of central nervous system demyelinating disease. History of clinically significant drug or alcohol usage in the last year or cannot maintain an alcohol intake of 30g a day or less throughout the study. History of or active alcoholism, alcoholic liver disease, or other chronic liver disease, including fibrosis, hepatitis and cirrhosis. History of or active renal or hematologic disease. Malignancies other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, or cervical carcinoma in situ. Erythrodermic, generalized pustular, new onset guttate, or medication-related or exacerbated psoriasis.Subject has a poorly controlled medical condition. Investigator considers the subject unsuitable for adalimumab or methotrexate therapy for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety, tolerability and clinical efficacy of adalimumab with placebo and with methotrexate in the treatment of moderate to severe chronic plaque psoriasis over a 16-week period. ;Secondary Objective: ;Primary end point(s): The primary efficacy variable in this study is the proportion of subjects achieving clinical response, defined as at least a 75% reduction in PASI score (³ PASI 75 response) at Week 16 relative to the Baseline (Week 0) PASI score.Subjects who do not have PASI assessments at Week 16 will be imputed as non-responders. | — |
Countries
Germany, Spain
Outcome results
None listed