A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil

A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil

Sponsors

Lead Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

Collaborator: Teva Pharmaceuticals USA

Source Pontificia Universidade Católica do Rio Grande do Sul
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 perform an exploratory substudy with advanced MRI using q-space diffusion protocol on a 3-Tesla MRI (GE Signa HDx 3.0T, General Electric, Milwaukee, WI, USA) and a 8-channel head coil to visualize remyelinating brain MS lesions. Normalized leptokurtic diffusion (NLD) data will be acquired using diffusion-weighted echo planar imaging. All MRI scans from this exploratory study will be performed at the Brain Institute of Rio Grande do Sul (BraIns). Only patients with previous brain demyelinating lesions will be included in this exploratory sub-study.

Overall Status Recruiting
Start Date 2017-03-01
Completion Date 2021-03-31
Primary Completion Date 2019-03-31
Study Type Observational
Primary Outcome
Measure Time Frame
Convertion rate to MS 2 years
Secondary Outcome
Measure Time Frame
Clinical features 2 years
epidemiology 2 years
autoantibodies 2 years
treatments 2 years
Enrollment 100
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: anti-aquaporin-4 antibody

Description: Serum anti-aquaporin-4 antibody

Intervention Type: Diagnostic Test

Intervention Name: anti-myelin oligodendrocyte glycoprotein

Description: Serum anti-myelin oligodendrocyte glycoprotein

Other Name: (anti-MOG)

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria: 1. Parents / patient have an understanding, ability and willingness to fully comply with study procedures 2. Parents / patient have the ability to provide voluntary written, signed and dated informed consent to participate in the study 3. Be 6 months - 18 years of age at screening 4. Have clinical evidence of at least 1 attack suggestive of idiopathic inflammatory CNS disorder 5. Have at least one brain MRI with available images (for review) - For the exploratory MRI study, parents / patients have to agree to perform 2 MRI scans (at baseline and at the end of the study). Considering the age of the study subjects, sedation may be required during the acquisition of the MRI. Exclusion Criteria: 1. Current evidence or known history of clinically significant infection including: - Chronic or ongoing active infectious disease requiring long-term systemic treatment such as active hepatitis B or C, HIV or tuberculosis 2. Current malignancy or history of malignancy in the past 5 years 3. Significant concurrent, uncontrolled medical condition that could affect subject's safety or impair the subject's participation in the study. 4. Current participation in any interventional trial. 5. Pregnant or breastfeeding

Gender: All

Minimum Age: 1 Month

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Douglas K Sato Principal Investigator Pontifical Catholic University of Rio Grande do Sul
Overall Contact

Last Name: Douglas K Sato, MD, PhD

Phone: +555133203218

Email: [email protected]

Location
Facility: Status: Contact:
Universidade Federal de Uberlândia | Uberlandia, MG, 38405320, Brazil Not yet recruiting Nivea Morales
Hospital da Restauração de Recife | Recife, PE, 50110900, Brazil Not yet recruiting Maria L Brito
Instituto de Neurologia de Curitiba | Curitiba, PR, 81210310, Brazil Recruiting Henry K Sato
Universidade Federal do Estado do Rio de Janeiro | Rio de Janeiro, RJ, 22290255, Brazil Not yet recruiting Claudia C Vasconcelos
Santa Casa de Misericordia de Porto Alegre | Porto Alegre, RS, 90020090, Brazil Not yet recruiting Marlise C Ribeiro
Pontifical Catholic University of Rio Grande do Sul | Porto Alegre, RS, 9061000, Brazil Recruiting Douglas K Sato
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto / Universidade de São Paulo | Ribeirao Preto, SP, 65470000, Brazil Not yet recruiting Vanessa Marques
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo | Sao Paulo, SP, 05403010, Brazil Recruiting Dagoberto Callegaro
Location Countries

Brazil

Verification Date

2017-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym EMOCEMP
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov

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