PsoriasisNCT01077128
Greek Study of the Quality of Life in Patients With Psoriasis Treated With Adalimumab
An observational study of Psoriasis, run by AbbVie (prior sponsor, Abbott) at 61 sites in Greece.
Trial summary
Primary objective To evaluate the quality of life of Adalimumab treated patients over a period of 12 months Secondary objectives To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical practice and in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 500 participants
- Where
- 61 sitesGreece
- Study dates
- Sep 2009to Sep 2012
- 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: Patients treated with Adalimumab according to routine medical practice from hospital and private physicians.
Who may be able to join
- Patients with moderate to severe chronic plaque psoriasis who are newly prescribed Humira (adalimumab) therapy (have never been treated with adalimumab before) and for whom the treating physician has made the decision that they are eligible for treatment with adalimumab in accordance with the terms of the local marketing authorization
- Patients with moderate to severe chronic plaque psoriasis for whom Adalimumab is indicated and has been prescribed according to the current approved local SPC as long as the first administration of adalimumab is not older than two months and they have not had dose interruptions since the initiation of adalimumab, and the Investigator can provide all the needed source documentation including a completed DLQI questionnaire at the start of Adalimumab treatment.
- Patient age ≥ 18
- Patient is willing to consent to data being collected and provided to Abbott
Who cannot join
- Patients who meet contraindications as outlined in the latest version of the local approved SPC
- Patients who participate in another clinical/observational study
- Patients who are not willing to sign an Informed Consent Form
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
Greece61 sites
Site Reference ID/Investigator# 43746
Agrinio, 301 00
Site Reference ID/Investigator# 30197
Amaliáda
Site Reference ID/Investigator# 30039
Argos, 21200
Site Reference ID/Investigator# 29903
Argyroúpoli
Site Reference ID/Investigator# 29819
Athens, 10673
Site Reference ID/Investigator# 29949
Athens, 11526
Site Reference ID/Investigator# 30804
Athens, 16121
Site Reference ID/Investigator# 30806
Athens, 16121
Site Reference ID/Investigator# 38324
Athens, 16121
Site Reference ID/Investigator# 22385
Athens
Site Reference ID/Investigator# 29826
Athens
Site Reference ID/Investigator# 29966
Athens
Site Reference ID/Investigator# 29991
Athens
Site Reference ID/Investigator# 30106
Athens
Site Reference ID/Investigator# 30107
Athens
Site Reference ID/Investigator# 30181
Athens
Site Reference ID/Investigator# 30470
Athens
Site Reference ID/Investigator# 30086
Chania, Crete, 73136
Site Reference ID/Investigator# 43744
Chania, Crete
Site Reference ID/Investigator# 30794
Crete, 71409
Site Reference ID/Investigator# 29937
Crete
Site Reference ID/Investigator# 29959
Crete
Site Reference ID/Investigator# 29969
Crete
Site Reference ID/Investigator# 38334
Drama
Site Reference ID/Investigator# 30801
Florina, 53100
Site Reference ID/Investigator# 29919
Giannitsá, 58100
Site Reference ID/Investigator# 30202
Giannitsá
Site Reference ID/Investigator# 29970
Glyfada, 16675
Site Reference ID/Investigator# 30013
Glyfada, 16675
Site Reference ID/Investigator# 29823
Glyfada
Site Reference ID/Investigator# 30193
Halandri
Site Reference ID/Investigator# 30083
Kalamaria
Site Reference ID/Investigator# 30143
Kallithea, 17672
Site Reference ID/Investigator# 47262
Katerini, 60100
Site Reference ID/Investigator# 38329
Keratsini
Site Reference ID/Investigator# 30108
Kolonaki, 10675
Site Reference ID/Investigator# 30009
Kosmos
Site Reference ID/Investigator# 38323
Larissa, 41100
Site Reference ID/Investigator# 38340
Larissa
Site Reference ID/Investigator# 29822
Livadeia
Site Reference ID/Investigator# 30180
Makri
Site Reference ID/Investigator# 29834
Mytilene
Site Reference ID/Investigator# 30469
Mytilene
Site Reference ID/Investigator# 38326
N.Heraklion
Site Reference ID/Investigator# 30032
Neapoli
Site Reference ID/Investigator# 30104
Pagkráti, 11634
Site Reference ID/Investigator# 29817
Pátrai
Site Reference ID/Investigator# 29967
Peiraius
Site Reference ID/Investigator# 38327
Peristeri
Site Reference ID/Investigator# 30109
Petralona
Site Reference ID/Investigator# 29824
Smyrni
Site Reference ID/Investigator# 38325
Thessaloniki, 54643
Site Reference ID/Investigator# 30769
Thessaloniki, 564 29
Site Reference ID/Investigator# 30170
Thessaloniki
Site Reference ID/Investigator# 38331
Thessaloniki
Site Reference ID/Investigator# 38332
Thessaloniki
Site Reference ID/Investigator# 38333
Thessaloniki
Site Reference ID/Investigator# 38335
Thessaloniki
Site Reference ID/Investigator# 38337
Thessaloniki
Site Reference ID/Investigator# 30203
Vári, 16672
Site Reference ID/Investigator# 29921
Volos
About this study
Official title: [E S] A Greek, Post-marketing, Observational Study of the quAlity of Life in Patients With Psoriasis Treated With Adalimumab - GOAL Study
Primary objective
- To evaluate the quality of life of Adalimumab treated patients over a period of 12 months
Secondary objectives
- To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical practice and in accordance with the terms of the European marketing authorization.
- To evaluate changes in patients quality of life according to treatment response over a 12-month period
- To observe and assess the long term use and safety of Adalimumab as prescribed by the dermatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization.
Read the detailed description
The aim of this post-marketing observational study in adult patients with moderate to severe chronic plaque psoriasis is to obtain further data on patient's Quality of Life and assess the impact of Adalimumab treatment on patient's quality of life in conditions of day-to-day clinical practice in Greece. This study will further assess the relationship between clinical outcomes and patient-reported outcomes. As this is an observational study, Abbott will not provide the study drug. Humira will be prescribed according to the routine medical practice. The participating physicians are free to determine the appropriate therapy for each patient and make treatment choices as deemed clinically necessary.
The Dermatology Life Quality Index (DLQI) will be used to assess patient quality of life. The Dermatology Life Quality Index (DLQI) total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The Dermatology Life Quality Index (DLQI) has well-established reliability and validity as determined in several studies. Moreover, it is frequently used in clinical trials of psoriasis.
The physician's global assessment of disease severity (PGA) will be used to measure patients' disease status at the time of assessment. It is a 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe).
Complementary, European Quality of Life-5 Dimensions health questionnaire (EQ5D) will be used as a measure of health outcome. This is applicable to a wide range of health conditions and treatments and it provides a simple descriptive profile and a single index value for health status. Health economic data will be collected by using European Quality of Life-5 Dimensions health questionnaire (EQ5D) questionnaire and data regarding patients hospitalisation due to psoriasis. Hospitalisation data will be collected 6 months before the period and throughout the observation period.
Moreover, this study will observe the current medical practice in prescribing Adalimumab in Greece and more detailed data on prescription behavior will be collected. Guidelines have been developed in order to ensure that the new class of therapy (biologic agents) is introduced in a systematic and planned way to achieve the greatest possible benefit to people with psoriasis and to facilitate safe and effective prescribing. However, many issues are not fully addressed, such as recommendation regarding the amount of time for wash out of previous antipsoriatic drugs and combination therapies. Such issues remain at the discretion of the healthcare professional. Since this is an observational study the patient will be treated in accordance with the physician's usual and customary medical practice. Thus, the following information regarding the use of Adalimumab will be collected
- the previous systemic treatment history will be recorded including previous biological therapies that patient received, if any,
- wash out periods prior to initiating Adalimumab therapy, if any
- reasons for stopping previous treatment,
- combination of Adalimumab with other topical or systemic antipsoriatic agents, if applicable
Furthermore, demographic data of patients suffering from psoriasis in Greece will be collected (age, gender, ethnicity) and disease data such as duration of the disease, involvement of nails or joints, geographic distribution of the disease in Greece will be collected.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Quality of life
- Medical subject headings
- Psoriasis
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 |
|---|---|---|
| Patients with psoriasis | All eligible patients with psoriasis treated with Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change of Dermatology Life Quality Index (DLQI) Scores
DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Measured: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)
Secondary outcomes (5)
Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
The Physician's Global Assessment of disease severity (PGA) was used to measure participants' disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores was recorded.
Measured: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician's Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region
The average change in the Dermatology Life Quality Index (DLQI) score during the 12-month study was analyzed by the Physician's Global Assessment of disease severity (PGA) response and also by geographical location of study participants. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life. . In this table, a higher number means a greater improvement in the participants' quality of life.
Measured: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)
EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.
It has two components:
- the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and
- the EQ-5D VAS. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either "problem" or "no problem" with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively.
Measured: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores
EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.
It has two components:
- the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and
- the EQ-5D VAS. EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either "problem" or "no problem" with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively.
Measured: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization
An adverse event (AE) was defined as any untoward medical occurrence in a participant, which did not necessarily have a causal relationship with their treatment. Any worsening of a pre-existing condition or illness was considered an adverse event.
Measured: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionSep 2012
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 PsoriasisStudies 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
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Athina Katsavou, MD, Study chair, AbbVie Pharmaceuticals S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077128
- Sponsor's protocol ID
- P11-984
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2010
- Last updated
- 21 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [E S] A Greek, Post-marketing, Observational Study of the quAlity of Life in Patients With Psoriasis Treated With Adalimumab - GOAL Study
- ClinicalTrials.gov ID
- NCT01077128
- Acronym / sponsor ID
- P11-984
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Posted 21 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective
- To evaluate the quality of life of Adalimumab treated patients over a period of 12 months
Secondary objectives
- To evaluate the long-term efficacy of Adalimumab in patients with moderate to severe chronic plaque psoriasis as prescribed by the dermatologists in day-to-day clinical practice and in accordance with the terms of the European marketing authorization.
- To evaluate changes in patients quality of life according to treatment response over a 12-month period
- To observe and assess the long term use and safety of Adalimumab as prescribed by the dermatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization.
Detailed description
The aim of this post-marketing observational study in adult patients with moderate to severe chronic plaque psoriasis is to obtain further data on patient's Quality of Life and assess the impact of Adalimumab treatment on patient's quality of life in conditions of day-to-day clinical practice in Greece. This study will further assess the relationship between clinical outcomes and patient-reported outcomes. As this is an observational study, Abbott will not provide the study drug. Humira will be prescribed according to the routine medical practice. The participating physicians are free to determine the appropriate therapy for each patient and make treatment choices as deemed clinically necessary.
The Dermatology Life Quality Index (DLQI) will be used to assess patient quality of life. The Dermatology Life Quality Index (DLQI) total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The Dermatology Life Quality Index (DLQI) has well-established reliability and validity as determined in several studies. Moreover, it is frequently used in clinical trials of psoriasis.
The physician's global assessment of disease severity (PGA) will be used to measure patients' disease status at the time of assessment. It is a 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe).
Complementary, European Quality of Life-5 Dimensions health questionnaire (EQ5D) will be used as a measure of health outcome. This is applicable to a wide range of health conditions and treatments and it provides a simple descriptive profile and a single index value for health status. Health economic data will be collected by using European Quality of Life-5 Dimensions health questionnaire (EQ5D) questionnaire and data regarding patients hospitalisation due to psoriasis. Hospitalisation data will be collected 6 months before the period and throughout the observation period.
Moreover, this study will observe the current medical practice in prescribing Adalimumab in Greece and more detailed data on prescription behavior will be collected. Guidelines have been developed in order to ensure that the new class of therapy (biologic agents) is introduced in a systematic and planned way to achieve the greatest possible benefit to people with psoriasis and to facilitate safe and effective prescribing. However, many issues are not fully addressed, such as recommendation regarding the amount of time for wash out of previous antipsoriatic drugs and combination therapies. Such issues remain at the discretion of the healthcare professional. Since this is an observational study the patient will be treated in accordance with the physician's usual and customary medical practice. Thus, the following information regarding the use of Adalimumab will be collected
- the previous systemic treatment history will be recorded including previous biological therapies that patient received, if any,
- wash out periods prior to initiating Adalimumab therapy, if any
- reasons for stopping previous treatment,
- combination of Adalimumab with other topical or systemic antipsoriatic agents, if applicable
Furthermore, demographic data of patients suffering from psoriasis in Greece will be collected (age, gender, ethnicity) and disease data such as duration of the disease, involvement of nails or joints, geographic distribution of the disease in Greece will be collected.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with psoriasis | – | –All eligible patients with psoriasis treated with Adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Adalimumab according to routine medical practice from hospital and private physicians.
Key inclusion criteria (4 listed)
- Patients with moderate to severe chronic plaque psoriasis who are newly prescribed Humira (adalimumab) therapy (have never been treated with adalimumab before) and for whom the treating physician has made the decision that they are eligible for treatment with adalimumab in accordance with the terms of the local marketing authorization
- Patients with moderate to severe chronic plaque psoriasis for whom Adalimumab is indicated and has been prescribed according to the current approved local SPC as long as the first administration of adalimumab is not older than two months and they have not had dose interruptions since the initiation of adalimumab, and the Investigator can provide all the needed source documentation including a completed DLQI questionnaire at the start of Adalimumab treatment.
- Patient age ≥ 18
- 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 local approved SPC
- Patients who participate in another clinical/observational study
- Patients who are not willing to sign an Informed Consent Form
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
Mean Change of Dermatology Life Quality Index (DLQI) Scores
Time frame: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)
DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
5 secondary outcomes
Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician's Global Assessment of Disease Severity (PGA) Scores
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician's Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Percentage of Patients Reporting "No Problem" on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization
Time frame: 12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Athina Katsavou, MD study chair
AbbVie Pharmaceuticals S.A.
61 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, run by AbbVie (prior sponsor, Abbott) at 61 sites in Greece.
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 4 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 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Greece. 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 21 Feb 2014). 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?
Mean Change of Dermatology Life Quality Index (DLQI) Scores (time frame: 12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)). 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 21 Feb 2014.