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

July 23, 2014 updated by: Innovaderm Research Inc.

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

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4X7
        • Centre De Recherche Dermatologique Du Quebec Metropolitain
    • Alberta
      • Calgary, Alberta, Canada, T2S3B3
        • Kirk Barber Research
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Winnipeg Clinic Dermatology Research
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Nexus Clinical Research
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1V6
        • Dermatrials Research
      • Markham, Ontario, Canada, L3P 1A8
        • Lynderm Research Inc.
      • Windsor, Ontario, Canada, N8W 5L7
        • Windsor Clinical Research Inc.
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research Inc.
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Diex Research Sherbrooke east
      • St-Hyacinthe, Quebec, Canada, J2S 6L6
        • Clinique Médicale Dr Isabelle Delorme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 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

This is where you will find people and organizations involved with this study.

Sponsor

Innovaderm Research Inc.

Collaborators

Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

July 1, 2014

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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