Clinical trial NCT01758705: Post Marketing Observational Study on Venezuelan Patients With Psoriasis
Official title: Observational Study; Clinical Effectiveness and Impact on Patient Reported Outcomes in Venezuelan Patients With Psoriasis After 16 Weeks of ADA Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Keywords: Psoriasis
Related to Health Quality of Life
Patient Reported Outcomes
Venezuelan Patients
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-01-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate
timeFrame: From Week 0 to Week 16
measure: Change in Percentage of patients with clinical difference in DLQI (Dermatology Life Quality Index) score
timeFrame: From Week 0 to Week 16
Secondary outcomes:
measure: Mean change of PASI score
timeFrame: From week 0 to week 16
measure: Mean change of DLQI score
timeFrame: From week 0 to week 16
measure: Changes in Psoriatic Arthritis Response Criteria (PsARC) score
timeFrame: From week 0 to week 16
measure: Mean change of Hospital Anxiety and Depression Score (HADS)
timeFrame: From week 0 to week 16
measure: Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score
timeFrame: From week 0 to week 16
measure: Percentage of subjects with Serious Adverse Events (SAEs)
timeFrame: Up to week 16
measure: Discontinuation of adalimumab for any reason.
timeFrame: Up to week 16
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Natali Serra-Bonett, MD
role: STUDY_CHAIR
References: