NCT02188654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

July 4, 2014

Last Update Submit

July 9, 2014

Conditions

Psoriatic Arthritis

Keywords

psoriatic arthritisinflammationmetabolic syndromemetformin

Outcome Measures

Primary Outcomes (1)

  • ACR20 response

    24 weeks

Secondary Outcomes (4)

  • PASI score

    24 weeks

  • Health Assessment Questionnaire

    24 weeks

  • Disability Index (HAQ-DI)

    24 weeks

  • Psoriatic arthritis response criteria (PsARC) score

    24 weeks

Study Arms (2)

Metformin

EXPERIMENTAL

500 mg metformin

Drug: Metformin

Placebo

PLACEBO COMPARATOR

500 mg of placebo tablets

Drug: Placebo

Interventions

MetforminDRUG

500mg/day retarded formulation of metformin

Metformin
PlaceboDRUG

500 mg/day of placebo tablets

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Psoriatic arthritis patients

You may not qualify if:

  • other inflammatory conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alexandria

Alexandria, Alexandria Governorate, 00203, Egypt

Location

MeSH Terms

Conditions

Arthritis, PsoriaticInflammationMetabolic Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Anna Abou-Raya, MD

    University of Alexandria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 11, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

EG(1)