Overview

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

Status:
Withdrawn
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Health Network, Toronto
Collaborator:
Novo Nordisk A/S
Treatments:
Liraglutide
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