Psoriatic ArthritisNCT01139918
Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis
An observational study of Psoriatic Arthritis and Psoriasis, run by Innovaderm Research Inc. at 10 sites in Canada.
Trial summary
This exploratory study will be used to identify questions that will be part of a new QoL questionnaire for patients with psoriasis and psoriatic arthritis and to determine the sample size needed for its validation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis, Psoriasis
- How many people
- 105 participants
- Where
- 10 sitesCanada
- Study dates
- Jun 2010to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Study popululation description: Patients suffering from either: moderate psoriatic arthritis and moderate psoriasis, mild psoriatic arthritis and moderate psoriasis or moderate psoriatic arthritis and mild psoriasis, known from dermatologists participating in the study.
Who may be able to join
- Patient with plaque psoriasis and psoriatic arthritis with either:
- Moderate psoriatic arthritis and moderate psoriasis defined as: [psoriatic arthritis with either 3-7 joints showing signs of synovitis OR a BASDAI of 2-4] AND [between 3 to less than 10% of the body surface area involved with psoriasis] (COHORT A) OR
- Mild psoriatic arthritis and Moderate psoriasis defined as: [psoriatic arthritis with either 1-2 joints showing signs of synovitis OR a BASDAI greater than 0 but less than 2] AND [between 3 to less than 10% of the body surface area involved with psoriasis] (COHORT B) OR
- Moderate psoriatic arthritis and Mild psoriasis defined as: [psoriatic arthritis with either 3-7 joints showing signs of synovitis OR a BASDAI of 2-4] AND [more than 0 but less than 3% of the body surface area involved with psoriasis] (COHORT C)
- Patient is between 18 years and older.
- Patient is capable of reading and understanding French or English questionnaires.
- Patient is capable of giving informed consent.
Who cannot join
- Patient has presence of eythrodermic, pustular or guttate psoriasis.
- Patient has another non psoriatic arthropathy (such as osteoarthritis) that could have a significant impact of QoL related to psoriatic arthritis
- Patient has another non psoriatic dermatosis that could have a significant impact on QoL related to psoriasis
- Patient has any other co-morbidity with a severity that could have a significant impact on QoL
- Patient has had a significant flare-up of psoriasis or psoriatic arthritis within 90 days of Day 0
- Patient has received investigational drugs within four weeks prior to Day 0
Show all 10Show fewer
- Patient has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy within the four weeks prior to Day 0. Methotrexate, sulphasalazine and leflunomide are allowed during the study as long as patient has been on a stable dose within 90 days of Day 0.
- Patient has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0
- Patient has used biologics (such etanercept, adalimumab, infliximab, abatacept, ustekinumab) within 180 days of Day 0
- Patient is currently pregnant or lactating.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Kirk Barber Research
Calgary, Alberta, T2S3B3
Dermatrials Research
Hamilton, Ontario, L8N 1V6
Lynderm Research Inc.
Markham, Ontario, L3P 1A8
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, G1V 4X7
Clinique Médicale Dr Isabelle Delorme
Saint-Hyacinthe, Quebec, J2S 6L6
Diex Research Sherbrooke east
Sherbrooke, Quebec, J1H 1Z1
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2
About this study
This exploratory study will be used to identify questions that will be part of a new QoL questionnaire for patients with psoriasis and psoriatic arthritis and to determine the sample size needed for its validation. The new questionnaire will be a global QoL questionnaire which will take into account the impact of both psoriasis and psoriatic arthritis on QoL.
STUDY OBJECTIVES
- To evaluate the influence of psoriasis and psoriatic arthritis on patient's answers to QoL questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36.
- To identify an equal number of questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36 where answers are mostly influenced either by psoriatic arthritis or by psoriasis.
Read the detailed description
This study will recruit three cohorts of 40 patients each: moderate psoriatic arthritis and moderate psoriasis, mild psoriatic arthritis and moderate psoriasis, moderate psoriatic arthritis and mild psoriasis. Eligible patients will fill the following questionnaires: Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire (HAQ), EQ-5D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) and 36-Item Short Form Health Survey Questionnaire (SF-36). In addition, each patient will be asked on a 4 point Likert scale how much their answer to each question is related to the impact of their skin disease or their psoriatic arthritis.
- Conditions
- Psoriatic Arthritis, Psoriasis
- Keywords
- psoriatic arthritis, psoriasis, Quality of life
- Medical subject headings
- Arthritis, Psoriatic, 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 |
|---|---|---|
| Cohort A | 40 patients with moderate psoriatic arthritis and moderate psoriasis | |
| Cohort B | 40 patients with mild psoriatic arthritis and moderate psoriasis | |
| Cohort C | 40 patients with moderate psoriatic arthritis and mild psoriasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
There is no primary outcome in this study. See objectives.
There is no primary outcome in this study. Patients with psoriatic arthritis and psoriasis answer questionnaires on one occasion.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139918
- Sponsor's protocol ID
- Inno-6017
- Status last verified
- Jul 2014
- First submitted
- 7 Jun 2010
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT01139918
- Acronym / sponsor ID
- Inno-6017
- Conditions
- Psoriatic Arthritis, Psoriasis
- Keywords
- psoriatic arthritis, psoriasis, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Amgen
- Study start
- Jun 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory study will be used to identify questions that will be part of a new QoL questionnaire for patients with psoriasis and psoriatic arthritis and to determine the sample size needed for its validation. The new questionnaire will be a global QoL questionnaire which will take into account the impact of both psoriasis and psoriatic arthritis on QoL.
STUDY OBJECTIVES
- To evaluate the influence of psoriasis and psoriatic arthritis on patient's answers to QoL questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36.
- To identify an equal number of questions from DLQI, HAQ, EQ-5D, FACIT-fatigue and SF-36 where answers are mostly influenced either by psoriatic arthritis or by psoriasis.
Detailed description
This study will recruit three cohorts of 40 patients each: moderate psoriatic arthritis and moderate psoriasis, mild psoriatic arthritis and moderate psoriasis, moderate psoriatic arthritis and mild psoriasis. Eligible patients will fill the following questionnaires: Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire (HAQ), EQ-5D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) and 36-Item Short Form Health Survey Questionnaire (SF-36). In addition, each patient will be asked on a 4 point Likert scale how much their answer to each question is related to the impact of their skin disease or their psoriatic arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –40 patients with moderate psoriatic arthritis and moderate psoriasis |
| Cohort B | – | –40 patients with mild psoriatic arthritis and moderate psoriasis |
| Cohort C | – | –40 patients with moderate psoriatic arthritis and mild psoriasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study popululation description: Patients suffering from either: moderate psoriatic arthritis and moderate psoriasis, mild psoriatic arthritis and moderate psoriasis or moderate psoriatic arthritis and mild psoriasis, known from dermatologists participating in the study.
Key inclusion criteria (7 listed)
- Patient with plaque psoriasis and psoriatic arthritis with either:
- Patient is between 18 years and older.
- Patient is capable of reading and understanding French or English questionnaires.
- Patient is capable of giving informed consent.
Key exclusion criteria (10 listed)
- Patient has presence of eythrodermic, pustular or guttate psoriasis.
- Patient has another non psoriatic arthropathy (such as osteoarthritis) that could have a significant impact of QoL related to psoriatic arthritis
- Patient has another non psoriatic dermatosis that could have a significant impact on QoL related to psoriasis
- Patient has any other co-morbidity with a severity that could have a significant impact on QoL
- Patient has had a significant flare-up of psoriasis or psoriatic arthritis within 90 days of Day 0
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
There is no primary outcome in this study. See objectives.
Time frame: 1 Day
There is no primary outcome in this study. Patients with psoriatic arthritis and psoriasis answer questionnaires on one occasion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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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.
Robert Bissonnette, MD principal investigator
Innovaderm Research Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis and Psoriasis, run by Innovaderm Research Inc. at 10 sites in Canada.
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 7 inclusion and 10 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
There is no primary outcome in this study. See objectives. (time frame: 1 Day). 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 24 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.