Treatment Interruption of Natalizumab

What Was Tested

This registered phase 2 trial tested Glatiramer Acetate for multiple sclerosis.

This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab.

The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks: * when MS symptoms return, and * if other drugs for MS may help control MS symptoms during the natalizumab-interruption period.

It had three arms (groups): natalizumab (active comparator), IV placebo (placebo comparator) and interferon β-1a, glatiramer acetate, or methylprednisolone (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 175 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A diagnosis of a relapsing form of MS. Treatment with natalizumab according to locally approved prescribing information. Other protocol defined inclusion/.

The full record lists 3 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-03 with completion listed for 2011-11.

It ran at 33 sites in United States (20), Germany (7) and Spain (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria (time frame: 28 Weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 175 people with multiple sclerosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.