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

This study has been completed.
Sponsor:
Collaborator:
Assign Data Management and Biostatistics GmbH
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01084668
First received: February 28, 2010
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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.


Condition
Psoriasis Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52 ] [ Designated as safety issue: No ]
    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).

  • Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75) [ Time Frame: Inclusion visit (Week 0) to Week 52 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Dermatology Life Quality Index (DLQI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52 ] [ Designated as safety issue: No ]
    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).

  • Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, and Week 52 ] [ Designated as safety issue: No ]
    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).

  • Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions [ Time Frame: From the time of participant consent until 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 46
Study Start Date: November 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adalimumab
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital, Dermatology

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084668

Locations
Austria
Site Reference ID/Investigator# 27435
Feldkirch, Austria, 6807
Site Reference ID/Investigator# 27436
Graz, Austria, 8010
Site Reference ID/Investigator# 38445
Graz, Austria, 8036
Site Reference ID/Investigator# 27443
Linz, Austria, 4020
Site Reference ID/Investigator# 27442
Vienna, Austria, 1030
Site Reference ID/Investigator# 27439
Vienna, Austria, A-1090
Site Reference ID/Investigator# 27437
Vienna, Austria, 1160
Site Reference ID/Investigator# 27440
Vienna, Austria, 1130
Site Reference ID/Investigator# 23309
Wels, Austria, 4600
Sponsors and Collaborators
Abbott
Assign Data Management and Biostatistics GmbH
Investigators
Study Director: Astrid Dworan-Timler, MD Abbott Austria
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01084668     History of Changes
Other Study ID Numbers: P10-708
Study First Received: February 28, 2010
Results First Received: April 26, 2012
Last Updated: June 25, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Abbott:
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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014