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Metformin in Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring psoriatic arthritis, inflammation, metabolic syndrome, metformin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Psoriatic arthritis patients

Exclusion Criteria:

  • other inflammatory conditions

Sites / Locations

  • University of Alexandria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

500 mg metformin

500 mg of placebo tablets

Outcomes

Primary Outcome Measures

ACR20 response

Secondary Outcome Measures

PASI score
Health Assessment Questionnaire
Disability Index (HAQ-DI)
Psoriatic arthritis response criteria (PsARC) score

Full Information

First Posted
July 4, 2014
Last Updated
July 9, 2014
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT02188654
Brief Title
Metformin in Psoriatic Arthritis
Official Title
Metformin: A Valid Add-On Drug in the Treatment of Psoriatic Arthritis-Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
psoriatic arthritis, inflammation, metabolic syndrome, metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
500 mg metformin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 mg of placebo tablets
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
500mg/day retarded formulation of metformin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
500 mg/day of placebo tablets
Primary Outcome Measure Information:
Title
ACR20 response
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
PASI score
Time Frame
24 weeks
Title
Health Assessment Questionnaire
Time Frame
24 weeks
Title
Disability Index (HAQ-DI)
Time Frame
24 weeks
Title
Psoriatic arthritis response criteria (PsARC) score
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Psoriatic arthritis patients Exclusion Criteria: other inflammatory conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Abou-Raya, MD
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alexandria
City
Alexandria
ZIP/Postal Code
00203
Country
Egypt

12. IPD Sharing Statement

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Metformin in Psoriatic Arthritis

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