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Natalizumab Re-Initiation of Dosing

An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation
CompletedPhase 3Relapsing MSNCT00306592

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Natalizumab

    Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor

Results by group

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)

Baseline through Week 48

GroupValueIntervalNumber analysed
300 mg Natalizumab IV Monthly826 participants1094
300 mg Natalizumab IV Monthly487 participants1094
300 mg Natalizumab IV Monthly66 participants1094
300 mg Natalizumab IV Monthly161 participants1094
300 mg Natalizumab IV Monthly61 participants1094
300 mg Natalizumab IV Monthly5 participants1094
300 mg Natalizumab IV Monthly24 participants1094
300 mg Natalizumab IV Monthly24 participants1094

Number of Participants With Hypersensitivity-related Adverse Events

Baseline through Week 48

GroupValueIntervalNumber analysed
300 mg Natalizumab IV Monthly8 participants1094

Number of Participants With Antibodies to Natalizumab

Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)

GroupValueIntervalNumber analysed
300 mg Natalizumab IV Monthly1004 participants1043
300 mg Natalizumab IV Monthly15 participants1043
300 mg Natalizumab IV Monthly8 participants1043
300 mg Natalizumab IV Monthly16 participants1043

300 mg Natalizumab IV Monthly

1004

300 mg Natalizumab IV Monthly

15

300 mg Natalizumab IV Monthly

8

300 mg Natalizumab IV Monthly

16

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
300 mg Natalizumab IV Monthly109461 (5.6%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)

    Baseline through Week 48

    Safety

  • Number of Participants With Hypersensitivity-related Adverse Events

    Baseline through Week 48

    Safety

  • Number of Participants With Antibodies to Natalizumab

    Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)

    How the body handles the medicine

Who could take part

Relapsing MS · 18 and over

Inclusion Criteria: * MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging [MRI] scan) * Considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 [NCT000276172] may be used) * Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Considered by the investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment * History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies * Other protocol-defined exclusion criteria may apply

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.

Papers

Loading reviews and guidelines…

Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Mar 2006

    2. Main results due

      Dec 2007

    3. Finished

      Feb 2008

    4. Results posted

      Jan 2010

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