Psoriasis ChronicQUALITYNCT01084668
Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs
An observational study of Psoriasis Chronic, run by Abbott at 9 sites in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Chronic
- How many people
- 46 participants
- Where
- 9 sitesAustria
- Study dates
- Nov 2008to Apr 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital, Dermatology
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Austria9 sites
Site Reference ID/Investigator# 27435
Feldkirch, 6807
Site Reference ID/Investigator# 27436
Graz, 8010
Site Reference ID/Investigator# 38445
Graz, 8036
Site Reference ID/Investigator# 27443
Linz, 4020
Site Reference ID/Investigator# 27442
Vienna, 1030
Site Reference ID/Investigator# 27440
Vienna, 1130
Site Reference ID/Investigator# 27437
Vienna, 1160
Site Reference ID/Investigator# 27439
Vienna, A-1090
Site Reference ID/Investigator# 23309
Wels, 4600
About this study
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)
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Inclusion visit (Week 0), Week 4, Week 36, Week 52
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).
Measured: Inclusion visit (Week 0) to Week 52
Secondary outcomes (3)
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).
Measured: Inclusion visit (Week 0), Week 4, Week 36, Week 52
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).
Measured: Inclusion visit (Week 0), Week 4, Week 36, and Week 52
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.
Measured: From the time of participant consent until 70 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startNov 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriasis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assign Data Management and Biostatistics GmbH
- Responsible party
- Sponsor
- Investigators
- Astrid Dworan-Timler, MD, Study director, Abbott Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084668
- Sponsor's protocol ID
- P10-708
- Acronym
- QUALITY
- Status last verified
- Jun 2012
- First submitted
- 28 Feb 2010
- Last updated
- 29 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01084668
- Acronym / sponsor ID
- QUALITY / P10-708
- 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 type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Assign Data Management and Biostatistics GmbH
- Study start
- Nov 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 30 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | – | –Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital, Dermatology
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psoriasis Area and Severity Index (PASI) Score
Time frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52
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
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).
3 secondary outcomes
Dermatology Life Quality Index (DLQI) Score
Time frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52
Nail Psoriasis Severity Index (NAPSI) Score
Time frame: Inclusion visit (Week 0), Week 4, Week 36, and Week 52
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Psoriasis Chronic
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Dworan-Timler, MD study director
Abbott Austria
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Chronic, run by Abbott at 9 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) Score (time frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.