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

AbbVie

Status: Terminated

Conditions: Moderate to Severe Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT01156532

P12-261

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Adalimumab Treatment in Participants with Psoriasis

Description:

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.