Post Marketing Observational Study on Venezuelan Patients With Psoriasis
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects male or female with moderate to severe chronic plaque psoriasis with or without psoriatic arthritis. Patients with history of psoriatic arthritis or articular symptoms must be evaluated by a Rheumatologist.
Subjects with moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis, who have the indication for adalimumab because they need systemic therapy or because they have had failure to phototherapy, or to other systemic or topical treatments
Subjects that are not receiving biologic therapy in the last 12 weeks or classical therapy in the past 4 weeks and/or phototherapy in the last 2 weeks. Topical therapy will be allowed, to a constant dose and will not be used within 24 hours prior to the visit
Patients under previous treatment with any experimental drug will have a minimum washout period of five half-lives
Subjects must be capable to understand and willing to give a written informed consent form to release information and to comply with the requirements of the study protocol
Subjects should not be enrolled if they cannot be treated in accordance with the local product label approved in Venezuela
Subjects enrolled into another study or under treatment with an investigational product
History of viral hepatitis B infection or HIV
History of neurologic symptoms suggestive of central nervous system demyelinating disease
History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
Active TB infection before initiating adalimumab treatment or latent TB infection not able to complete prophylactic treatment
Pregnant or lactating female. Pregnancy will be tested before entering the study in fertile women. Women in fertile age must be advised by the physician, to use a clinically accepted contraceptive method (contraceptive pills, IUDs, barrier devices as condoms or abstinence)
History of congestive heart failure (CHF)
Any another condition that according to the criteria of the participating investigator represents an obstacle for study conduction and / or subjects to an unacceptable risks
Subjects with active infection including chronic or localized infections until infections are controlled
History of sensitive to latex or other component of the syringe
Subjects who requires concomitant phototherapy and systemic therapy during adalimumab therapy