NCT04832399

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2013

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

9.9 years

First QC Date

March 16, 2021

Last Update Submit

February 2, 2024

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

  • Overall Disease-Free Status at Month 12

    Month 12

  • Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year

    Month 12

  • Annualized Relapse Rate at Month 12 in Comparison to the Previous Year

    Month 12

Secondary Outcomes (11)

  • Overall Disease-Free Status at Months 24, 36 and 48

    Months 24, 36 and 48

  • Clinical Disease-free Status Every 6 Months

    Every 6 months (Up to 48 months)

  • Annualized Relapse Rate (ARR)

    Months 12, 24, 36 and 48

  • Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained)

    Months 12, 24, 36 and 48

  • MRI measures: T2, T1, T1 with Gadolinium (Gd)

    Months 12, 24, 36 and 48

  • +6 more secondary outcomes

Study Arms (1)

Natalizumab

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

Drug: Natalizumab

Interventions

NatalizumabDRUG

As described in the treatment arm.

Also known as: Tysabri, BG00002
Natalizumab

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research Site

Amadora, 2720-276, Portugal

Location

Research Site

Angra do Heroísmo, 9700-049, Portugal

Location

Research Site

Aveiro, 3810-164, Portugal

Location

Research Site

Braga, 4710-243, Portugal

Location

Research Site

Coimbra, 3004-561, Portugal

Location

Research Site

Faro, 8000-386, Portugal

Location

Research Site

Funchal, 9000-177, Portugal

Location

Research Site

Guimarães, 4835-044, Portugal

Location

Research Site

Leiria, 2410-197, Portugal

Location

Research Site

Lisbon, 1649-028, Portugal

Location

Research Site

Loures, 2674-514, Portugal

Location

Research Site

Matosinhos Municipality, 4450-021, Portugal

Location

Research Site

Penafiel, 4564-007, Portugal

Location

Research Site

Porto, 4200-319, Portugal

Location

Research Site

Santa Maria da Feira, 4520-220, Portugal

Location

Research Site

Setúbal, 2910-446, Portugal

Location

Research Site

Viana do Castelo, 4904-858, Portugal

Location

Research Site

Vila Nova de Gaia, 4434-502, Portugal

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

April 5, 2021

Study Start

November 12, 2013

Primary Completion

October 2, 2023

Study Completion

October 2, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations

PT(18)