Post Marketing Observational Study on Venezuelan Patients With Psoriasis

NCT01758705 | Withdrawn

• 1 other identifier: P13-709
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (1)

Cohort 1

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Natali Serra-Bonett, MD

  Abbott

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2012
• First Posted: January 1, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11