Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

NCT ID: NCT01156532

Last Updated: 2014-08-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-08-31

Brief Summary

Adalimumab has recently been authorized for active psoriasis in Peru and local experience is very low. The aim of this study is to obtain Peruvian data of clinical effectiveness and impact on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis complying with the dosing and monitoring recommendations of the local approved label.

Conditions

Moderate to Severe Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adalimumab Treatment in Participants with Psoriasis

Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate
• Participant is capable of and willing to give written informed consent and to comply with the requirements of the study protocol

Exclusion Criteria

• Participants should not be enrolled if they cannot be treated in accordance with the local product label
• Participants enrolled into another study or clinical trial
• History of hepatitis B infection
• 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 tuberculosis infection before initiating adalimumab treatment or latent tuberculosis infection not able to take complete prophylactic treatment
• Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method
• Use of another anti-tumoral necrosis factor previously
• History of congestive heart failure
• Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects participants to an unacceptable risk
• Participants with active infection including chronic or localized infections until infections are controlled
• History of sensitivity to latex
• Participants who will receive concomitant phototherapy and systemic therapy during adalimumab therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Uribe, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 35783

Lima, , Peru

Site Reference ID/Investigator# 56700

Lima, , Peru

Site Reference ID/Investigator# 43147

Trujillo, , Peru

Countries

Peru

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P12-261

Identifier Type: -

Identifier Source: org_study_id