An interventional study of Metformin and Placebo in Psoriatic Arthritis, sponsored by University of Alexandria. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-11.
Sponsored by University of Alexandria · Not applicable, Interventional, and Treatment
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 56 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of Alexandria is the lead sponsor of 57 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
500 mg metformin
Drug: Metformin
500 mg of placebo tablets
Drug: Placebo
500mg/day retarded formulation of metformin
500 mg/day of placebo tablets
ACR20 response
Time frame: 24 weeks
PASI score
Time frame: 24 weeks
Health Assessment Questionnaire
Time frame: 24 weeks
Disability Index (HAQ-DI)
Time frame: 24 weeks
Psoriatic arthritis response criteria (PsARC) score
Time frame: 24 weeks
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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University of Alexandria