Metformin in Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT02188654

Recruitment Status : Completed

First Posted : July 11, 2014

Last Update Posted : July 11, 2014

Sponsor:

Information provided by (Responsible Party):

Anna Abou-Raya, University of Alexandria

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriatic Arthritis	Drug: Metformin Drug: Placebo	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	56 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Metformin: A Valid Add-On Drug in the Treatment of Psoriatic Arthritis-Randomized Controlled Trial
Study Start Date :	September 2013
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	April 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Psoriatic arthritis

MedlinePlus related topics: Arthritis Psoriatic Arthritis

Drug Information available for: Metformin Metformin hydrochloride

Genetic and Rare Diseases Information Center resources: Spondylarthropathy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Metformin 500 mg metformin	Drug: Metformin 500mg/day retarded formulation of metformin
Placebo Comparator: Placebo 500 mg of placebo tablets	Drug: Placebo 500 mg/day of placebo tablets

Outcome Measures

Primary Outcome Measures :

ACR20 response [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Psoriatic arthritis patients

Exclusion Criteria:

other inflammatory conditions

Contacts and Locations

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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): NCT02188654

Locations

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Egypt
University of Alexandria
Alexandria, Egypt, 00203

Sponsors and Collaborators

University of Alexandria

Investigators

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Principal Investigator:	Anna Abou-Raya, MD	University of Alexandria

More Information

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Responsible Party:	Anna Abou-Raya, MD, University of Alexandria
ClinicalTrials.gov Identifier:	NCT02188654
Other Study ID Numbers:	alexmed12671416
First Posted:	July 11, 2014 Key Record Dates
Last Update Posted:	July 11, 2014
Last Verified:	July 2014

Keywords provided by Anna Abou-Raya, University of Alexandria:


psoriatic arthritis inflammation metabolic syndrome metformin

Additional relevant MeSH terms:

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Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases	Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs

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