A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a

Relapsing-remitting Multiple Sclerosis Clinical Trial

— PRTOECT  

Official title:

Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00771043
• Other study ID #: US 010-07-NAT
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 1, 2008
• Est. completion date: June 1, 2010

Study information

• Verified date: May 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2010
• Est. primary completion date: August 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of RRMS.

• Patients with unilateral AON consistent with Multiple Sclerosis (MS).

• Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset.

• Age 18-55 years.

• Expanded Disability Status Scale (EDSS) 0 to 5.0.

• Understand and sign informed consent.

Exclusion Criteria:

• History or presence of progressive multifocal leukoencephalopathy (PML).

• Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS).

• Immune-compromised in the judgment of the Investigator.

• History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study.

• Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).

• Previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis (ON) with the most recent ON symptom onset being less than 12 months ago.

• Previous treatment with > 1 Disease Modifying Therapy (DMT).

• Previous treatment with investigational products for MS, immunosuppressant or cytotoxic therapy.

• Previous treatment with TYSABRI®

• Women who are not postmenopausal, surgically sterile, or willing to practice contraception.

• Women pregnant, breast feeding, or planning to become pregnant.

• Involved with other study protocol simultaneously without prior approval.

• Determined not suitable for study participation by Investigator and/or Sponsor.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• TYSABRI and AVONEX
TYSABRI and AVONEX treatment per package insert.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.		Between week 4 and weeks 36
Secondary	Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.		Between week 4 and weeks 36