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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00336557
First received: June 12, 2006
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Multiple Sclerosis
Procedure: NAbs testing
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The nature of any therapy/management change in each arm [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Reason for change in therapy/management [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 1230
Study Start Date: July 2006
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336557

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

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00336557     History of Changes
Other Study ID Numbers: PM028
Study First Received: June 12, 2006
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014