Retinal Nerve Fiber Layer (RNFL) as measured by Optical Coherence Tomography (OCT) to Depict axonal loss in Early RRMS treated with difFEreNt dosage of subCutaneous IFN bEta 1a - DEFENCE

Phase 1

• Conditions: Patients with RR-MS diagnosis; MedDRA version: 9.1Level: LLTClassification code 10063399

• Registration Number: EUCTR2009-015007-97-IT
• Lead Sponsor: DR. ENRICO MONTANARI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

oRR-MS diagnosis according to the revised Mc Donald criteria
oRRMS diagnosis within 2 years
oPatients of both sexes, aged 18-50 years
oPatients DMDs treatment na?ve
oPatients valid informed consent to take part in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

oPrimary or secondary progressive MS
oPatients with previous DMD treatment courses
oPatients receiving oral or parenteral steroid or ACTH courses within the 30 days preceding visit 1 (prior to enrolment)
oPatients unwilling to comply with study requirements
oContra-indications for IFN-β1a treatment as defined in the SmPC or hypersensitivity to any components of formulation
oSuffer of dementia (DSM IV criteria) with a SIDAM score <33
oSuffer of major medical or psychiatric illness
oPrevious history of NORB
oContra-indications for tropicamide: patients with a narrow angle between the iris and cornea; closed angle glaucoma; hypersensitivity to tropicamide or any excipients of the formulation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified