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

NCT ID: NCT01084668

Last Updated: 2012-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-04-30

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.

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

Study Design

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

Study Groups

Adalimumab

Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure

No interventions assigned to this group

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

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

Sponsors

Assign Data Management and Biostatistics GmbH

OTHER

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid Dworan-Timler, MD

Role: STUDY_DIRECTOR

Abbott Austria

Locations

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# 27442

Vienna, , Austria

Site Reference ID/Investigator# 27440

Vienna, , Austria

Site Reference ID/Investigator# 27437

Vienna, , Austria

Site Reference ID/Investigator# 27439

Vienna, , Austria

Site Reference ID/Investigator# 23309

Wels, , Austria

Countries

Austria

Other Identifiers

P10-708

Identifier Type: -

Identifier Source: org_study_id