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NCT Number: NCT00336557

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Phoenix Neurological Associates, LTD, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NAbs testing

Procedure

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

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. The nature of any therapy/management change in each arm

    Time frame: 1 year

  2. Reason for change in therapy/management

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 13, 2006
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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