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

NCT00771043 | Withdrawn Phase 4

• 1 other identifier: US 010-07-NAT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.

  Between week 4 and weeks 36

Secondary Outcomes (1)

• Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.

  Between week 4 and weeks 36

Study Arms (2)

TYSABRI

EXPERIMENTAL

Drug: TYSABRI and AVONEX

AVONEX

EXPERIMENTAL

Drug: TYSABRI and AVONEX

Interventions

TYSABRI and AVONEX DRUG

TYSABRI and AVONEX treatment per package insert.

AVONEX; TYSABRI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Natalizumab; Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 10, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: June 1, 2010
• Last Updated: June 3, 2024

Record last verified: 2024-05