Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy

A Randomized, Controlled, Open-Label Parallel Group Study to Evaluate the Effect of Regularly Scheduled Neutralizing Antibody Testing on Treatment Patterns Versus Usual Care in High-Dose Interferon Treated Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00336557

Enrollment

1230

Registered

2006-06-13

Start date

2006-07-31

Completion date

2009-07-31

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

High-Dose Interferon, Neutralizing Antibodies

Brief summary

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Detailed description

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Interventions

PROCEDURENAbs testing

blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Willing to provide informed consent. * Male or female, 18 years of age or older, with a diagnosis of MS.

Exclusion criteria

* Has been on oral or parenteral corticosteroid therapy within the two weeks prior to the Baseline Visit. * Has been treated with immunoglobulins (IgG) or plasmapheresis within the last six months. * Has any condition which the investigator or nurse feels may interfere with participation in the study or with assessments for the full duration of the study. * Previously participated in this study. * Has received an experimental drug in the last thirty (30) days.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm	1 year

Secondary

Measure	Time frame
The nature of any therapy/management change in each arm	1 year
Reason for change in therapy/management	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026