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

NCT02472717 | Withdrawn Phase 2

• 1 other identifier: U1111-1150-8501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis; Psoriasis; Impaired Glucose Tolerance; Type 2 Diabetes

Keywords

liraglutide, GLP-1 receptor agonists

Outcome Measures

Primary Outcomes (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

  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 Outcomes (5)

• 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

  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

  Baseline to 12 weeks

Other Outcomes (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

  Baseline to 12 weeks

Study Arms (2)

Interventional arm

EXPERIMENTAL

liraglutide 0.6mg sc daily for 1 week, 1.2mg sc daily for 11 weeks

Drug: liraglutide

Placebo arm

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

liraglutide DRUG

Liraglutide 0.6mg sc daily for 1 week, 1.2mg sc daily for 11 weeks

Also known as: Victoza

Interventional arm

Placebo OTHER

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

Placebo arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Toronto Western Hospital, The Centre for Prognosis Studies in the Rheumatic Diseases (CPSRD), University of Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis; Glucose Intolerance; Diabetes Mellitus, Type 2

Interventions

Liraglutide

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; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 16, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 17, 2017

Record last verified: 2015-06

Locations

CA (1)