Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pontificia Universidade Católica do Rio Grande do Sul
With
Teva Pharmaceuticals USA
Age
0–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil
