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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015007-97-IT

Enrollment

144

Registered

2009-10-01

Start date

2010-02-16

Completion date

Unknown

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with RR-MS diagnosis MedDRA version: 9.1 Level: LLT Classification code 10063399

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: Interferon beta-1a Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 44- Pharmaceutical Form: Soluti

Eligibility

Sex/Gender

All

Inclusion criteria

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

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-&#946;1a 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate whether Retinal Nerve Fiber Layer (RNFL) as measured by Optical Coherence Tomography (OCT) is able to show IFN beta 1a dose-response axonal loss in early RRMS patients.;Secondary Objective: to evaluate the relationship between RNFL findings and clinical, conventional MRI, and NPS test measurements;Primary end point(s): Evaluate RNFL thickness changes in early RRMS patients treated with two different dosages of IFN beta 1a at 12 and 24 months of treatment	—

Measure

Time frame

Main Objective: To demonstrate whether Retinal Nerve Fiber Layer (RNFL) as measured by Optical Coherence Tomography (OCT) is able to show IFN beta 1a dose-response axonal loss in early RRMS patients.;Secondary Objective: to evaluate the relationship between RNFL findings and clinical, conventional MRI, and NPS test measurements;Primary end point(s): Evaluate RNFL thickness changes in early RRMS patients treated with two different dosages of IFN beta 1a at 12 and 24 months of treatment

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026