Clinical trial NCT01156532: Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
Official title: Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Moderate to Severe Psoriasis
Keywords: adalimumab therapy
Psoriasis
observational study
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-07-05
Enrollment: 30
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: Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.

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.


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

Primary outcomes:
measure: Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
timeFrame: Baseline to Week 16
measure: Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
measure: Adherence to Adalimumab Treatment
timeFrame: up to 16 weeks
measure: Mean Psoriasis Area and Severity Index (PASI) Score Over Time
timeFrame: Baseline, Week 4, Week 8, Week 16
measure: Mean Dermatology Life Quality Index (DLQI) Score Over Time
timeFrame: Baseline, Week 4, Week 8, Week 16
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Site Reference ID/Investigator# 35783
city: Lima
country: Peru
facility: Site Reference ID/Investigator# 56700
city: Trujillo
country: Peru
facility: Site Reference ID/Investigator# 43147
Study officials:
affiliation: AbbVie
name: Manuel Uribe, MD
role: STUDY_DIRECTOR
References: