A multicentre, single arm, open-label, phase IV study to evaluate the
A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
Proportion of subjects developing NAbs at week 48.
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
Inclusion: To be eligible for inclusion into this study, each subject must fulfil the following criteria within 28 days prior to Study Day 0: Exclusion: 1. Prior Interferon beta therapy (either beta-1b or beta-1a).
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 the trial is to compare the immunogenicity of Rebif® (clone 484-39), by examining the proportion of subjects developing NAbs in subjects newly exposed to Rebif® (clone 484-39), to historical data on incidence of NAbs development for Rebif® from Serono Phase III clinical trials after 48 weeks of therapy. Data pooled from multiple studies in MS, using a dose of 44mcg tiw, has shown that the proportion of patients who have persistent NAb at 12 months is 20% and which falls to 18% by 24 months.
Loading reviews and guidelines…
Related trials
- Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting
Phase 3 · Not yet recruiting
Still running
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting
Still running
- Discontinuation of first-line disease modifying treatment (DMT) in lon
Phase 4 · Stopped early
Stopped
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY
Running, not recruiting
Still running
- Study to Investigate Pregnancy Outcomes in Female Participants Exposed
Completed
Paper found, not read
- A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017
Phase 3 · Running, not recruiting
Still running
History
Started
Sept 2004