Post Marketing Observational Study on Venezuelan Patients With Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-03-31

Brief Summary

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The aim of this study is to obtain Venezuelan data of clinical effectiveness, impact in the HRQoL, work productivity and activity impairment in patients with psoriasis using adalimumab.

Detailed Description

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Conditions

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Moderate to Severe Chronic Plaque Psoriasis

Keywords

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Psoriasis Related to Health Quality of Life Patient Reported Outcomes Venezuelan Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natali Serra-Bonett, MD

Role: STUDY_CHAIR

Abbott

Countries

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Venezuela

Other Identifiers

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P13-709

Identifier Type: -

Identifier Source: org_study_id