| Trial ID: | L4254 |
| Source ID: | NCT02472717
|
| Associated Drug: |
Liraglutide
|
| Title: |
Psoriatic Arthritis Treated With Liraglutide Therapy: a QUality of Life and Efficacy Study
|
| Acronym: |
PLAQUE
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Psoriatic Arthritis|Psoriasis|Impaired Glucose Tolerance|Type 2 Diabetes
|
| Interventions: |
DRUG: liraglutide|OTHER: Placebo
|
| Outcome Measures: |
Primary: The change in the proportion of patients achieving an ACR 20% improvement response in patients with psoriatic arthritis receiving liraglutide for 12 weeks compared to placebo, Proportion of patients achieving an ACR (American College of Rheumatology) 20% improvement response. ACR 20 is a composite rheumatological endpoint which includes swollen joint count, tender joint count, pain, physician global assessment, patient global assessment, HAQ (health assessment questionnaire), CRP (c reactive protein)., Baseline to 12 weeks, liraglutide compared to placebo | Secondary: The change in the psoriasis area and severity index (PASI) in patients with psoriatic arthritis receiving liraglutide for 12 weeks compared to those receiving placebo, Baseline to 12 weeks|The change in quality of life measured by validated quality of life questionnaires in patients with psoriatic arthritis receiving liraglutide for 12 weeks compared to those receiving placebo, Baseline to 12 weeks|The change in glucose tolerance in patients with psoriatic arthritis with glucose intolerance at baseline who receive liraglutide for 12 weeks compared to those receiving placebo, Baseline to 12 weeks|The effect(s) of liraglutide on cardiovascular disease risk factors in patients with psoriatic arthritis receiving liraglutide for 12 weeks compared to those receiving placebo, Cardiovascular disease risk factors (Systolic blood pressure, cholesterol profiles, CRP, body weight, waist circumference), Baseline to 12 weeks|The effect(s) of liraglutide on the enumeration of circulating T-cell subpopulations, and on activation of circulating T-cell subpopulations, Multi-parameter phospho flow cytometry analysis of T-cell differentiation and activation of peripheral blood, Baseline to 12 weeks | Other: The effect of liraglutide on levels of infiltrating dermal T cells and cytokines in psoriatic skin plaques from patients with psoriatic arthritis receiving liraglutide therapy for 12 weeks compared to those receiving placebo, Baseline to 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Health Network, Toronto | Collaborators: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-05
|
| Completion Date: |
2016-10
|
| Results First Posted: |
|
| Last Update Posted: |
2017-07-17
|
| Locations: |
Toronto Western Hospital, The Centre for Prognosis Studies in the Rheumatic Diseases (CPSRD), University of Toronto, Toronto, Ontario, M5T 2S8, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02472717
|
