Natalizumab Subcutaneous Immunogenicity and Safety Study
A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Sponsor's decision.
This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Proportion of participants with persistent anti-natalizumab antibodies
48 weeks
The proportion of subjects with persistent anti-natalizumab antibodies over 48 weeks. Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit.
Other measures (6)
Proportion of participants with transient anti-natalizumab antibodies
48 weeks
Proportion of participants with post-injection adverse events (AEs)
48 weeks
SafetyProportion of participants with clinical relapse
48 weeks
RelapsesMRI lesionsProportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.
48 weeks
MRI lesionsProportion of Participants that experience Adverse Events and Serious Adverse Events
up to 56 weeks
Safety• The proportion of subjects with transient anti-natalizumab antibodies over 48 weeks.
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 6.5
Show the full criteria
Inclusion criteria
Key Inclusion Criteria: * Must have documented diagnosis of RMS at screening. * Must fall within the therapeutic indications stated in the locally approved label for natalizumab. * Must have an EDSS score from 0 to 6.5, inclusive. Key Exclusion Criteria: * Any prior use of natalizumab. * Positive for anti-natalizumab antibodies at screening. * Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening. 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 evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.
Loading reviews and guidelines…
Related trials
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting
Still running
- A Study Utilising Data From European Union (EU) National Multiple Scle
Running, not recruiting
Still running
- A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated M
Stopped early
Stopped
- A Study to Investigate the Radiological Onset of Action After Treatmen
Phase 4 · Stopped early
Stopped
- The 'Wearing Off' Effect of DMT
Completed
No results found
- A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacody
Phase 3 · Stopped early
Stopped: not working
History
Started
Dec 2014
Main results due
Jun 2015
Finished
Jun 2015