- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01139918
Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Quebec, Canada, G1V 4X7
- Centre de Recherche Dermatologique Du Quebec Metropolitain
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Alberta
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Calgary, Alberta, Canada, T2S3B3
- Kirk Barber Research
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
- Winnipeg Clinic Dermatology Research
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Canada, A1A 5E8
- Nexus Clinical Research
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Ontario
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Hamilton, Ontario, Canada, L8N 1V6
- Dermatrials Research
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Markham, Ontario, Canada, L3P 1A8
- Lynderm Research Inc.
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Windsor, Ontario, Canada, N8W 5L7
- Windsor Clinical Research Inc.
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Quebec
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Montreal, Quebec, Canada, H2K 4L5
- Innovaderm Research Inc.
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Sherbrooke, Quebec, Canada, J1H 1Z1
- Diex Research Sherbrooke east
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St-Hyacinthe, Quebec, Canada, J2S 6L6
- Clinique Médicale Dr Isabelle Delorme
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort A
40 patients with moderate psoriatic arthritis and moderate psoriasis
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Cohort B
40 patients with mild psoriatic arthritis and moderate psoriasis
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Cohort C
40 patients with moderate psoriatic arthritis and mild psoriasis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 Day
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Inno-6017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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