Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants (TYPIFI)

Biogen

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Natalizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04832399

PRT-TYS-12-10409

Details and patient eligibility

About

The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS).

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Documented diagnosis of Relapsing Remitting Multiple Sclerosis (McDonald 2010 Criteria).
• EDSS ≤ 3.0.
• Must fulfill Tysabri indication (relapse and MRI criteria).
• Decision to start treatment with Natalizumab must precede enrollment.
• Up to four natalizumab infusions.

Key Exclusion Criteria:

• Any prior treatment with Natalizumab.
• Prior imunossupressive treatment (Mitoxantrone, Azathioprine, Methotrexate, Cyclophosphamide, Mycophenolate, Cladribine, Rituximab).
• Contraindications to treatment with Natalizumab.
• History of Progressive Multifocal Leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
• Immunocompromised at the time of enrollment. Known active malignancies.
• Inability to comply with study requirements.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

60 participants in 1 patient group

Natalizumab

Description:

Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks.

Treatment:

Drug: Natalizumab