Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs

Psoriasis Chronic Clinical Trial

— QUALITY  

Official title:

A Post-marketing Observational Study of the Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic DMARDs Over a Period of 1 Year (QUALITY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084668
• Other study ID #: P10-708
• Status: Completed
• Phase: N/A
• First received: February 28, 2010
• Last updated: June 25, 2012
• Start date: November 2008
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial Summary

The aim of this post-marketing observational study (PMOS) was to obtain further data on long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical use in participants with moderate to severe chronic plaque psoriasis after unsustainable clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There are few data so far showing the effects of switching from other BDMARDs to adalimumab in patients with moderate to severe chronic plaque psoriasis. This study was designed to evaluate the long-term effectiveness of adalimumab in participants with moderate to severe chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants previously treated with efalizumab, infliximab, or etanercept and who either never achieved satisfactory response, achieved satisfactory response initially but lost it over time, or discontinued treatment due to intolerance/side effect(s) or other reasons, for example after regular stop of etanercept.

Description:

This was a non-interventional PMOS conducted in a prospective, single-country, multicenter format to assess the quality of life of psoriasis patients taking adalimumab as prescribed by their physician in accordance with the terms of the local marketing authorization with regard to dose, population, and indication. The prescription of adalimumab was clearly separated from the decision to include the participant in this study. No procedures other than standard of care were to have been performed. Visits were non-interventional and timing of participant appointments was left to each physician. After therapy initiation, visits occurred over 12 months usually close to Weeks 4, 12, 24, 36, and 52 for a total of 6 visits (Visits 1 through 6 including Screening). Because participant visits were left to the physician, participant failure to meet the suggested visit weeks did not constitute a breach of the protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients for whom adalimumab therapy is indicated and has been prescribed according to the product label

• Patients aged 18 years and older

• Unsatisfactory response to prior BDMARDS (efalizumab, infliximab, etanercept) in patients with moderate to severe chronic plaque psoriasis or achievement of satisfactory response initially, but loss over time or discontinuation of treatment due to intolerance/side effects(s) or other reasons e.g. restart after regular stop of etanercept

• Patients must fulfill Austrian Treatment Recommendations for use of BDMARD in psoriasis (chest X-ray and purified protein derivative [PPD] skin test negative for tuberculosis)

• Patient is willing to consent to data being collected and provided to Abbott

• Patient must be able and willing to self-administer Pen injections or have a qualified person available to administer Pen injections

Exclusion Criteria:

• Patients who meet contraindications as outlined in the latest version of the Humira-Pen Summary of Product Characteristics (SPC)

• Patients who do not meet the criteria for the use of BDMARDs of the Austrian Treatment Recommendations

• Patients participating in another study or clinical trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Chronic

Locations

Country	Name	City	State
Austria	Site Reference ID/Investigator# 27435	Feldkirch
Austria	Site Reference ID/Investigator# 27436	Graz
Austria	Site Reference ID/Investigator# 38445	Graz
Austria	Site Reference ID/Investigator# 27443	Linz
Austria	Site Reference ID/Investigator# 27437	Vienna
Austria	Site Reference ID/Investigator# 27439	Vienna
Austria	Site Reference ID/Investigator# 27440	Vienna
Austria	Site Reference ID/Investigator# 27442	Vienna
Austria	Site Reference ID/Investigator# 23309	Wels

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Assign Data Management and Biostatistics GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index (PASI) Score	Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).	Inclusion visit (Week 0), Week 4, Week 36, Week 52	No
Primary	Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)	PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).	Inclusion visit (Week 0) to Week 52	No
Secondary	Dermatology Life Quality Index (DLQI) Score	Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).	Inclusion visit (Week 0), Week 4, Week 36, Week 52	No
Secondary	Nail Psoriasis Severity Index (NAPSI) Score	The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).	Inclusion visit (Week 0), Week 4, Week 36, and Week 52	No
Secondary	Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions	Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.	From the time of participant consent until 70 days after last dose of study drug	Yes