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A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil (EMOCEMP)

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ClinicalTrials.gov Identifier: NCT03087136
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Multiple Sclerosis Diagnostic Test: anti-aquaporin-4 antibody Diagnostic Test: anti-myelin oligodendrocyte glycoprotein

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: anti-aquaporin-4 antibody
    Serum anti-aquaporin-4 antibody
  • Diagnostic Test: anti-myelin oligodendrocyte glycoprotein
    Serum anti-myelin oligodendrocyte glycoprotein
    Other Name: (anti-MOG)


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical features [ Time Frame: 2 years ]
    • To compare the clinical and MRI features between pediatric MS patients with disease onset < 10 and > 10 years

  2. epidemiology [ Time Frame: 2 years ]
    • To analyze the influence of latitude, ethnicity and past viral infections on the development of pediatric MS

  3. 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)

  4. 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



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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, 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.

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

Information from the National Library of Medicine

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): NCT03087136


Contacts
Contact: Douglas K Sato, MD, PhD +555133203218 douglas.sato@pucrs.br

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

Responsible Party: Pontificia Universidade Católica do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03087136     History of Changes
Other Study ID Numbers: 61080516.4.1001.5336
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pontificia Universidade Católica do Rio Grande do Sul:
multiple sclerosis
pediatric

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Krestin
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents