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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Innovaderm Research Inc.
ClinicalTrials.gov Identifier:
NCT01139918
First received: June 7, 2010
Last updated: July 23, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Innovaderm Research Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 105
Study Start Date: June 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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 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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139918

Locations
Canada, Alberta
Kirk Barber Research
Calgary, Alberta, Canada, T2S3B3
Canada, Manitoba
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Newfoundland and Labrador
Nexus Clinical Research
St John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
Dermatrials Research
Hamilton, Ontario, Canada, L8N 1V6
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1A8
Windsor Clinical Research Inc.
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Diex Research Sherbrooke east
Sherbrooke, Quebec, Canada, J1H 1Z1
Clinique Médicale Dr Isabelle Delorme
St-Hyacinthe, Quebec, Canada, J2S 6L6
Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Innovaderm Research Inc.
Amgen
Investigators
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: July 23, 2014
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 August 01, 2014