Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis

Psoriasis Clinical Trial

Official title:

Exploratory Study on Quality of Life in Patient With Moderate Psoriasis and Moderate Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139918
• Other study ID #: Inno-6017
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: July 23, 2014
• Start date: June 2010
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Innovaderm Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis

Locations

Country	Name	City	State
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	Centre de Recherche Dermatologique du Quebec Metropolitain	Quebec
Canada	Diex Research Sherbrooke east	Sherbrooke	Quebec
Canada	Nexus Clinical Research	St John's	Newfoundland and Labrador
Canada	Clinique Médicale Dr Isabelle Delorme	St-Hyacinthe	Quebec
Canada	Windsor Clinical Research Inc.	Windsor	Ontario
Canada	Winnipeg Clinic Dermatology Research	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Innovaderm Research Inc.	Amgen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Day	No