Status:
COMPLETED
Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis
Lead Sponsor:
Innovaderm Research Inc.
Collaborating Sponsors:
Amgen
Conditions:
Psoriatic Arthritis
Psoriasis
Eligibility:
All Genders
18+ years
Brief 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 i...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01139918
Start Date
June 1 2010
End Date
July 1 2014
Last Update
July 24 2014
Active Locations (10)
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1
Kirk Barber Research
Calgary, Alberta, Canada, T2S3B3
2
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, Canada, R3C 0N2
3
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
4
Dermatrials Research
Hamilton, Ontario, Canada, L8N 1V6