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Monoclonal Antibodies
Natalizumab for Multiple Sclerosis
Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 2: baseline (week 108) up to week 180
Awards & highlights
Summary
This trial is evaluating the efficacy of natalizumab extended interval dosing (EID) in participants who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The trial will also evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of EID in participants who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.
Eligible Conditions
- Multiple Sclerosis, Relapsing-Remitting
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part 2: baseline (week 108) up to week 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 2: baseline (week 108) up to week 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Mean Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72
Secondary study objectives
Part 1: Annualized Relapse Rate at Week 72
Part 1: Mean Number of New Gadolinium (Gd) Enhancing Lesions at Weeks 24, 48, and 72
Part 1: Mean Number of New T1 Hypointense Lesions at Weeks 24, 48, and 72
+12 moreSide effects data
From 2011 Phase 4 trial • 19 Patients • NCT0114405244%
Injection site reaction
33%
Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Interferon-beta-1b
Natalizumab
Trial Design
5Treatment groups
Experimental Treatment
Group I: Part 2: Run-in Period: IV Q6WExperimental Treatment1 Intervention
Participants who completed Part 1 or were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 72 through Week 102.
Group II: Part 2: Crossover Period: SC Q6W, then IV Q6WExperimental Treatment1 Intervention
Participants who completed run-in period of Part 2 were randomized to receive natalizumab 300 mg SC injection Q6W from Week 108 through Week 126 followed by natalizumab 300 mg IV infusion Q6W from Week 132 through Week 150 along with a single dose of natalizumab 300 mg SC injection or IV infusion as per participant's choice at Week 156.
Group III: Part 2: Crossover Period: IV Q6W, then SC Q6WExperimental Treatment1 Intervention
Participants who completed run-in period of Part 2 were randomized to receive natalizumab 300 mg IV infusion Q6W from Week 108 through Week 126 followed by natalizumab 300 mg subcutaneous (SC) injection Q6W from Week 132 through Week 150 along with a single dose of natalizumab 300 mg SC injection or IV infusion as per participant's choice at Week 156.
Group IV: Part 1: IV Q6WExperimental Treatment1 Intervention
Participants received natalizumab 300 mg IV infusion once Q6W up to Week 72.
Group V: Part 1: IV Q4WExperimental Treatment1 Intervention
Participants received natalizumab 300 mg intravenous (IV) infusion once Q4W up to Week 72.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natalizumab
FDA approved
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Who is running the clinical trial?
BiogenLead Sponsor
643 Previous Clinical Trials
466,634 Total Patients Enrolled
226 Trials studying Multiple Sclerosis
141,423 Patients Enrolled for Multiple Sclerosis
Medical DirectorStudy DirectorBiogen
2,859 Previous Clinical Trials
8,081,544 Total Patients Enrolled
136 Trials studying Multiple Sclerosis
125,614 Patients Enrolled for Multiple Sclerosis
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