Metformin in Psoriatic Arthritis

Not Applicable

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT02188654
• Lead Sponsor: University of Alexandria

Brief Summary

Psoriatic arthritis (PsA) is a systemic, inflammatory disease. The chronic inflammation in PsA predisposes patients to the metabolic syndrome (MetS). MetS is associated with systemic inflammation and proinflammatory cytokines. Clinical observations and experimental results argue for an anti-inflammatory and immunosuppressant property of MET.

Detailed Description

The chronic inflammatory nature of psoriasis and PsA predisposes patients to cardiovascular diseases and metabolic syndrome (MetS). MetS is associated with systemic inflammation and proinflammatory cytokines.Clinical observations and experimental results argue for an anti-inflammatory and immunosuppressant property of MET.

A randomized placebo-controlled trial was conducted to evaluate the efficacy and safety of metformin as add-on therapy to MTX compared to MTX after 24 weeks in patients with PsA.

The study randomized 56 patients with a diagnosis of PsA . Patients with a history of a cardiovascular event and diabetics were excluded. Body mass index (BMI) and classic cardiovascular risk factors were recorded. Blood samples were analysed for glucose, lipid profile, ESR, hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6) and IL-17. The homeostasis model assessment model for insulin resistance (HOMA-IR) was used. The patients were randomized in a 1:1 ratio to receive 500mg/day retarded formulation of metformin (n=29) or placebo (n=29). Continuation of stable doses of MTX (25mg/week), NSAIDs, and/or corticosteroids (prednisone \<10 mg/day) was permitted. Metformin drug pause on the day of MTX was given. Folic acid supplementation was given to both groups. The primary clinical endpoint was the ACR 20% (ACR20) response at 24 weeks. Secondary endpoints included reduction in PASI score, Health Assessment Questionnaire- Disability Index (HAQ-DI) and Psoriatic arthritis response criteria (PsARC) score.

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Psoriatic arthritis patients

Exclusion Criteria

• other inflammatory conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	500 mg of placebo tablets
Metformin	Metformin	500 mg metformin

Primary Outcome Measures

Name	Time	Method
ACR20 response	24 weeks

Secondary Outcome Measures

Name	Time	Method
PASI score	24 weeks
Health Assessment Questionnaire	24 weeks
Disability Index (HAQ-DI)	24 weeks
Psoriatic arthritis response criteria (PsARC) score	24 weeks

Trial Locations

Locations (1)

University of Alexandria; 🇪🇬 Alexandria, Egypt