Post Marketing Observational Study on Venezuelan Patients With Psoriasis

Observational Study; Clinical Effectiveness and Impact on Patient Reported Outcomes in Venezuelan Patients With Psoriasis After 16 Weeks of ADA Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Moderate to Severe Chronic Plaque Psoriasis

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate		From Week 0 to Week 16
Change in Percentage of patients with clinical difference in DLQI (Dermatology Life Quality Index) score	Clinical difference is defined by a minimal important difference (MID) in DLQI score between 2.3-5 at 16 weeks	From Week 0 to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of PASI score		From week 0 to week 16
Mean change of DLQI score		From week 0 to week 16
Changes in Psoriatic Arthritis Response Criteria (PsARC) score		From week 0 to week 16
Mean change of Hospital Anxiety and Depression Score (HADS)		From week 0 to week 16
Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score		From week 0 to week 16
Percentage of subjects with Serious Adverse Events (SAEs)	Occurrence of SAEs including tuberculosis, other opportunistic infections and cancer	Up to week 16
Discontinuation of adalimumab for any reason.		Up to week 16

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Chair: Natali Serra-Bonett, MD, Abbott

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: December 26, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: November 26, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Psoriasis; Patient Reported Outcomes; Related to Health Quality of Life; Venezuelan Patients
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: P13-709