Exploratory Study of the Safety, Tolerability and Efficacy of Multiple
A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis
What it found
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
Placebo
- IV Placebo
- SC Placebo
Results by group
Cumulative Number of Combined Unique Active Lesions
Up to Week 60
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Randomized Period: Natalizumab 300 mg IV Every 4 Weeks | 0.23 lesions | 1.262 (Standard Deviation) | 52 |
| Randomized Period: Natalizumab 300 mg SC Every 4 Weeks | 0.02 lesions | 0.151 (Standard Deviation) | 44 |
| Randomized Period: Natalizumab 300 mg IV Every 12 Weeks | 3.84 lesions | 8.054 (Standard Deviation) | 45 |
| Randomized Period: Natalizumab 300 mg SC Every 12 Weeks | 3.08 lesions | 8.216 (Standard Deviation) | 50 |
| Randomized Period: Natalizumab 150 mg IV Every 12 Weeks | 6.09 lesions | 15.424 (Standard Deviation) | 35 |
| Randomized Period: Natalizumab 150 mg SC Every 12 Weeks | 6.44 lesions | 11.285 (Standard Deviation) | 32 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Randomized Period: Natalizumab 300 mg IV Every 4 Weeks | 54 | 7 (13.0%) | |
| Randomized Period: Natalizumab 300 mg SC Every 4 Weeks | 45 | 4 (8.9%) | |
| Randomized Period: Natalizumab 300 mg IV Every 12 Weeks | 52 | 4 (7.7%) | |
| Randomized Period: Natalizumab 300 mg SC Every 12 Weeks | 53 | 3 (5.7%) | |
| Randomized Period: Natalizumab 150 mg IV Every 12 Weeks | 47 | 4 (8.5%) | |
| Randomized Period: Natalizumab 150 mg SC Every 12 Weeks | 38 | 1 (2.6%) | |
| Open-label Period: Natalizumab 300 mg IV Every 4 Weeks | 44 | 0 (0.0%) | |
| Open-label Period: Natalizumab 300 mg SC Every 4 Weeks | 35 | 1 (2.9%) | |
| Open-label Period: Natalizumab 300 mg IV Every 12 Weeks | 42 | 0 (0.0%) | |
| Open-label Period: Natalizumab 300 mg SC Every 12 Weeks | 42 | 1 (2.4%) | |
| Open-label Period: Natalizumab 150 mg IV Every 12 Weeks | 42 | 1 (2.4%) | |
| Open-label Period: Natalizumab 150 mg SC Every 12 Weeks | 32 | 2 (6.3%) |
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
Cumulative Number of Combined Unique Active Lesions
Up to Week 60
MRI lesionsCumulative number of combined unique active lesions (sum of the number of new Gd enhancing and new or newly enlarging T2 hyperintense lesions not associated with Gd enhancement on T1 weighted scans) based on brain MRI scans.
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: * Ability to provide written informed consent * Subjects of childbearing potential must practice effective contraception during the study * A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) * Free of MS relapse for 12 months prior to randomization * Treatment with natalizumab for a minimum of 12 months immediately prior to randomization. * In the 12 months prior to commencing natalizumab, subject must have experienced a minimal level of disease activity as defined by 2 or more documented clinical relapses OR 1 relapse and documented MRI activity, defined by the presence of at least 1 Gd enhancing lesion on MRI, unrelated to the relapse. Key Exclusion Criteria: * Known history of Human Immunodeficiency Virus (HIV), hepatitis C and/or hepatitis B virus * Positive for anti-natalizumab antibodies at screening * MRI positive for Gd-enhancing lesions at study entry * Subjects for whom MRI is contraindicated * History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease * History of malignant disease, including solid tumors and hematologic malignancies (with the exception of cured basal cell and squamous cell carcinomas of the skin) * History of transplantation or any anti-rejection therapy * History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug * A clinically significant infectious illness within 30 days prior to screening or progressive multifocal leukoencephalopathy (PML) or other opportunistic infections at any time * Signs or symptoms suggestive of any serious infection, based on medical history, physical examination or laboratory testing NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).
Papers
Results
A randomized study of natalizumab dosing regimens for relapsing-remitting multiple sclerosis.Mult Scler · 2021
Loading reviews and guidelines…
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History
Started
Aug 2011
Main results due
Apr 2014
Finished
Oct 2014
Results posted
Jul 2015