Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis
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Purpose
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.
| Condition |
|---|
|
Psoriatic Arthritis Psoriasis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis |
- There is no primary outcome in this study. See objectives. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]There is no primary outcome in this study. Patients with psoriatic arthritis and psoriasis answer questionnaires on one occasion.
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| Contact: Murielle Tremoy, M.Sc. | (514) 521 4285 ext 238 | mtremoy@innovaderm.ca |
| Contact: Annie Levesque, M.Sc. | (514) 521 4285 ext 222 | alevesque@innovaderm.ca |
| Canada, Alberta | |
| Kirk Barber Research | Recruiting |
| Calgary, Alberta, Canada, T2S3B3 | |
| Contact: Kirk Barber, MD 403-299-5821 kirk@kirkbarber.ca | |
| Contact: Arjuni Seevaratnam 403-299-5821 arjuni@kirkbarber.ca | |
| Principal Investigator: Kirk Barber, MD | |
| Sub-Investigator: Maysan Abu-Hakima, MD | |
| Canada, Manitoba | |
| Winnipeg Clinic Dermatology Research | Recruiting |
| Winnipeg, Manitoba, Canada, R3C 0N2 | |
| Contact: Kathy Peters 204-957-3390 wcderm@mts.net | |
| Principal Investigator: Richard P Haydey, MD | |
| Sub-Investigator: Tarek Afifi, MD | |
| Sub-Investigator: Robert W Mouton, MD | |
| Sub-Investigator: Victoria K Taraska, MD | |
| Sub-Investigator: Rachelle S Van De Velde, MD | |
| Canada, Newfoundland and Labrador | |
| Nexus Clinical Research | Recruiting |
| St John's, Newfoundland and Labrador, Canada, A1A 5E8 | |
| Contact: Ian DR Landells, MD 709 726 3386 landells@nexusresearch.com | |
| Principal Investigator: Ian DR Landells, MD | |
| Sub-Investigator: Majed Khraishi, MD | |
| Canada, Ontario | |
| Dermatrials Research | Recruiting |
| Hamilton, Ontario, Canada, L8N 1V6 | |
| Contact: Ronald Vender, MD 905 524 0012 drvender@dermatrials.com | |
| Principal Investigator: Ronald B Vender, MD | |
| Sub-Investigator: Francis R Murphy, MD | |
| Sub-Investigator: William Bensen, MD | |
| Lynderm Research Inc. | Recruiting |
| Markham, Ontario, Canada, L3P 1A8 | |
| Contact: Charles W Lynde, MD 905 471 8011 derma@lynderma.com | |
| Principal Investigator: Charles W Lynde, MD | |
| Sub-Investigator: Francesca Cheung, MD | |
| Sub-Investigator: Joanne Lewtas, MD | |
| Sub-Investigator: Calvin Goodman, MD | |
| Windsor Clinical Research Inc. | Completed |
| Windsor, Ontario, Canada, N8W 5L7 | |
| Canada, Quebec | |
| Innovaderm Research Inc. | Recruiting |
| Montreal, Quebec, Canada, H2K 4L5 | |
| Contact: Mukelda Castor 514 521-4285 ext 267 mcastor@innovaderm.ca | |
| Principal Investigator: Robert Bissonnette, MD | |
| Sub-Investigator: Chantal Bolduc, MD | |
| Sub-Investigator: Catherine Maari, MD | |
| Sub-Investigator: Simon Nigen, MD | |
| Sub-Investigator: Boulos Haraoui, MD | |
| Diex Research Sherbrooke east | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Contact: Jean-François Lessard 819.346.2887 ext 236 jflessard@diex.ca | |
| Principal Investigator: Louise Loranger, MD | |
| Sub-Investigator: Monique Camerlain, MD | |
| Clinique Médicale Dr Isabelle Delorme | Recruiting |
| St-Hyacinthe, Quebec, Canada, J2S 6L6 | |
| Contact: Isabelle Delorme, MD (450) 771 7070 docteure@dreisabelledelorme.com | |
| Contact: Frederic Couture, Nurse (450) 771 7070 recherche@dreisabelledelorme.com | |
| Principal Investigator: Isabelle Delorme, MD | |
| Sub-Investigator: Boulos Haraoui, MD | |
| Canada | |
| Centre de Recherche Dermatologique du Quebec Metropolitain | Recruiting |
| Quebec, Canada, G1V 4X7 | |
| Contact: Yves Poulin, MD 418 650 0777 crdq@bellnet.ca | |
| Principal Investigator: Yves Poulin, MD | |
| Sub-Investigator: Louis Bessette, MD | |
| Principal Investigator: | Robert Bissonnette, MD | Innovaderm Research Inc. |
More Information
No publications provided
| Responsible Party: | Innovaderm Research Inc. |
| ClinicalTrials.gov Identifier: | NCT01139918 History of Changes |
| Other Study ID Numbers: | Inno-6017 |
| Study First Received: | June 7, 2010 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Innovaderm Research Inc.:
|
psoriatic arthritis psoriasis Quality of life |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Psoriasis Joint Diseases Musculoskeletal Diseases Spondylarthropathies |
Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013