Clinical trial NCT01084668: Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Chronic
Keywords: moderate to severe chronic plaque psoriasis
adalimumab
Psoriasis Area and Severity Index (PASI)
Disease Life Quality Index (DLQI)
Nail Psoriasis Severity Index (NAPSI)
biologic disease modifying anti-rheumatic drug (BDMARD)
antibodies
monoclonals
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Assign Data Management and Biostatistics GmbH
First posted: 2010-03-10
Enrollment: 46
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: Hospital, Dermatology

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) Score
timeFrame: Inclusion visit (Week 0), Week 4, Week 36, Week 52
measure: Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)
timeFrame: Inclusion visit (Week 0) to Week 52
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI) Score
timeFrame: Inclusion visit (Week 0), Week 4, Week 36, Week 52
measure: Nail Psoriasis Severity Index (NAPSI) Score
timeFrame: Inclusion visit (Week 0), Week 4, Week 36, and Week 52
measure: Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions
timeFrame: From the time of participant consent until 70 days after last dose of study drug
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Site Reference ID/Investigator# 27435
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 27436
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 38445
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 27443
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27442
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27440
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27437
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27439
city: Wels
country: Austria
facility: Site Reference ID/Investigator# 23309
Study officials:
affiliation: Abbott Austria
name: Astrid Dworan-Timler, MD
role: STUDY_DIRECTOR
References: