Clinical Trial: A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil

Brief Summary:

Pediatric Multiple sclerosis (MS) is a chronic inflammatory disease defined by multiple episodes of demyelination of the central nervous system (CNS) separated by time and space as specified in adults not explained by acute disseminated encephalomyelitis (ADEM). Several studies have indicated that at least 5% of MS patients are in the pediatric population, but no prospective study was performed in Brazil. There are particular characteristics of Pediatric MS that differs from the adult population and have been focus of interest in the last years. However, we still lack high evidence data, specially concerning treatment, of this age group.

This is an observational non-interventional multicenter study in pediatric MS patients in which participating subjects will be characterized by their clinical, MRI and immunological features. In this observational study, we will select 8 MS centers in Brazil to recruit at least 100 pediatric patients currently followed on each center with idiopathic inflammatory CNS disorders over a 2-year study period. We will collect retrospective and prospective clinical and MRI data to determine the proportion of patients who fulfill the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for MS,7 especially on those below 10 years where the use of McDonald 2010 criteria is not recommended routinely. Following the inclusion on the study, subjects will be followed for at least 2 years.

All subjects enrolled in this study will have serum collected to test autoantibodies including anti-AQP4 and anti-MOG using cell-based assays with transfected cells.8 Pediatric patients with positive testing for these autoantibodies will be analyzed separately.

Exploratory MRI sub-study In 10 patients recruited at Hospital São Lucas PUCRS, we will

Detailed Summary:
Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

Current Primary Outcome: Convertion rate to MS [ Time Frame: 2 years ]

To evaluate the proportion of patients (below and above 10 years-old) with idiopathic inflammatory CNS disorders converting to pediatric MS in Brazilian MS referral centers.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical features [ Time Frame: 2 years ]
    • To compare the clinical and MRI features between pediatric MS patients with disease onset < 10 and > 10 years
  • epidemiology [ Time Frame: 2 years ]
    • To analyze the influence of latitude, ethnicity and past viral infections on the development of pediatric MS
  • autoantibodies [ Time Frame: 2 years ]
    • To determine the proportion of patients with pediatric MS and other inflammatory demyelinating CNS disorders with autoantibodies (anti-AQP4 and anti-MOG)
  • treatments [ Time Frame: 2 years ]
    • To identify the disease-modifying treatments used in pediatric MS cases by the treating physician and the occurrence of adverse events


Original Secondary Outcome: Same as current

Information By: Pontificia Universidade Católica do Rio Grande do Sul

Dates:
Date Received: March 15, 2017
Date Started: March 1, 2017
Date Completion: March 31, 2021
Last Updated: March 15, 2017
Last Verified: March 2017