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

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ClinicalTrials.gov Identifier: NCT00336557
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

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.

Condition or disease Intervention/treatment
Multiple Sclerosis Procedure: NAbs testing

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.

Study Type : Observational
Actual Enrollment : 1230 participants
Observational Model: Case Control
Time Perspective: Prospective
Official 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
Study Start Date : July 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Regularly Scheduled NAb Testing Arm
Subjects will be scheduled for 5 study visits over the course of 12 months and any NAbs test results will be available to the investigator during the study.
Procedure: NAbs testing
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
Usual Care Arm
Subjects will be scheduled for 2 study visits over the course of 12 months and any NAbs test results will be unknown by the investigator until the conclusion of the subject's study participation.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who have been on high-dose Interferon (IFN) for 1 to 4 years
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336557


  Show 49 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Chair: Stephen Glenski, PharmD Teva Neuroscience, Inc.

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00336557     History of Changes
Other Study ID Numbers: PM028
First Posted: June 13, 2006    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Teva Pharmaceutical Industries:
High-Dose Interferon
Neutralizing Antibodies

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Antibodies, Blocking
Interferons
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents