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Trial record 10 of 396 for:    LIRAGLUTIDE

Psoriatic Arthritis Treated With Liraglutide Therapy: a QUality of Life and Efficacy Study (PLAQUE)

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ClinicalTrials.gov Identifier: NCT02472717
Recruitment Status : Withdrawn
First Posted : June 16, 2015
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
Exploratory, double-blind randomized, placebo-controlled, Phase II study to evaluate the effect(s) of short-term administration of liraglutide, a GLP-1R (glucagon-like peptide-1 receptor) agonist on joint and skin inflammation in patients with active Psoriatic Arthritis.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Psoriasis Impaired Glucose Tolerance Type 2 Diabetes Drug: liraglutide Other: Placebo Phase 2

Detailed Description:

The primary purpose of this study is to determine whether short-term (12-week) administration of the GLP-1R agonist, liraglutide, will improve joint and skin swelling in patients with active Psoriatic Arthritis compared to placebo.

Background: Psoriatic Arthritis is a systemic inflammatory T-cell disorder affecting the joints and spine, and is associated with an elevated risk for Type 2 Diabetes and Cardiovascular Disease. In addition to classical effects on glycemic-lowering, GLP-1R agonists are anti-diabetes agents which also have anti-inflammatory properties that may be clinically useful for patients with inflammatory diseases, particularly those with co-morbid metabolic disease. While a few small exploratory studies in patients with psoriasis have demonstrated that GLP-1R agonists reduce the severity of skin plaques, dedicated prospective, randomized mechanistic studies evaluating potential mechanisms by which GLP-1R agonists exert anti-inflammatory action(s) in humans with inflammatory disease is lacking.

Objectives: Primary objective is to evaluate the clinical efficacy of short-term liraglutide (GLP-1R agonist) administration on the severity of joint and skin inflammation in patients with active Psoriatic Arthritis. Secondary objectives are to determine whether short-term liraglutide administration in patients with active psoriatic arthritis will 1) modify the degree of impaired glucose tolerance, underlying b-cell function and cardiovascular risk factor profiles, 2) improve patient-centered outcomes such as quality of life and functionality, 3) modify specific sub-populations of T-cells and affect their differentiation and activation, and 4) modify activation of circulating immune cells, pro-inflammatory cytokines, and hormones.

Design: Double-blind, randomized, placebo-controlled trial, Phase II.

Patient population: 34 patients between with active Psoriatic Arthritis meeting CASPAR (ClASsification criteria for Psoriatic ARthritis).

Intervention: Participants will be randomized (1:1) to liraglutide (1.2 mg sc daily) or to placebo (sc daily) for 12 weeks.

Endpoints: The primary endpoint of this study will be the proportion of patients who experience a 20% ACR (American College of Rheumatology) improvement response following liraglutide therapy as compared to placebo.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Psoriatic Arthritis Treated With Liraglutide. The PLAQUE Study: Psoriatic Arthritis Treated With Liraglutide Therapy: a QUality of Life and Efficacy Study
Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: Interventional arm
liraglutide 0.6mg sc daily for 1 week, 1.2mg sc daily for 11 weeks
Drug: liraglutide
Liraglutide 0.6mg sc daily for 1 week, 1.2mg sc daily for 11 weeks
Other Name: Victoza

Placebo Comparator: Placebo arm
Placebo sc daily for 12 weeks, volume titration at week 2 to mirror liraglutide arm
Other: Placebo
Placebo sc daily for 12 weeks, volume titration at week 2 to mirror liraglutide arm




Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline to 12 weeks, liraglutide 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).


Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline to 12 weeks ]
  2. 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 [ Time Frame: Baseline to 12 weeks ]
  3. 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 [ Time Frame: Baseline to 12 weeks ]
  4. 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 [ Time Frame: Baseline to 12 weeks ]
    Cardiovascular disease risk factors (Systolic blood pressure, cholesterol profiles, CRP, body weight, waist circumference)

  5. The effect(s) of liraglutide on the enumeration of circulating T-cell subpopulations, and on activation of circulating T-cell subpopulations [ Time Frame: Baseline to 12 weeks ]
    Multi-parameter phospho flow cytometry analysis of T-cell differentiation and activation of peripheral blood


Other Outcome Measures:
  1. 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 [ Time Frame: Baseline to 12 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with active psoriatic arthritis (3 tender and swollen joints) meeting CASPAR study group criteria

Exclusion Criteria:

  • BMI > 35 kg/m2
  • Uncontrolled diabetes, HbA1c > 10.5%
  • Current biological treatment for any inflammatory disorder within the past three months
  • renal dysfunction (eGFR < 50 ml/min/1.73m or macroalbuminuria >300mg)
  • hepatic dysfunction (AST (aspartate aminotransferase), ALT (alanine aminotransferase), Total bilirubin > 3 times upper limit of normal)
  • history of pancreatitis or personal or family history of medullary thyroid cancer, c-cell hyperplasia, or MEN-2 syndrome
  • current pregnancy or current breast feeding
  • use of DPP-4 (dipeptidyl peptidase-4 inhibitor) or GLP-1 receptor agonist within 2 months (washout is permitted)
  • drug or alcohol dependence
  • resting tachycardia > 100 bpm or conduction abnormalities associated with tachycardia
  • current enrollment in any other clinical trial
  • symptomatic gastroparesis
  • concomitant serious medical conditions
  • all medication for the treatment of Psoriatic Arthritis such as MTX (methotrexate) < 25 mg, LFN (leflunomide) < 20 mg, and NSAIDs (non-steroidal anti-inflammatory drugs) will have been used at stable doses for at least 4 weeks, having been initiated at least 3 months prior to study start (8 weeks before screening, 4 weeks before baseline) for MTX and LFN and at least 4 weeks for NSAIDs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472717


Locations
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Canada, Ontario
Toronto Western Hospital, The Centre for Prognosis Studies in the Rheumatic Diseases (CPSRD), University of Toronto
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Novo Nordisk A/S

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02472717     History of Changes
Other Study ID Numbers: U1111-1150-8501
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: June 2015
Keywords provided by University Health Network, Toronto:
liraglutide, GLP-1 receptor agonists
Additional relevant MeSH terms:
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Liraglutide
Arthritis
Arthritis, Psoriatic
Psoriasis
Glucose Intolerance
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists