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

NCT01139918 | Completed

• 1 other identifier: Inno-6017
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 10

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 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.

Conditions

Psoriatic Arthritis; Psoriasis

Keywords

psoriatic arthritis; psoriasis; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Amgen: collaborator

Study Sites (10)

Kirk Barber Research

Calgary, Alberta, T2S3B3, Canada

Location

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1V6, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1A8, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Clinique Médicale Dr Isabelle Delorme

Saint-Hyacinthe, Quebec, J2S 6L6, Canada

Location

Diex Research Sherbrooke east

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

CA (10)