Observational Study to Determine Impact of Multiple NAb Tests on Treatment Patterns Compared to the Usual Care of MS Patients Receiving High-Dose IFN Therapy - Full Text View

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00336557

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 IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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

Further study details as provided by Teva Pharmaceutical Industries:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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

Enrollment:	1354
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 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.
2 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:

Randomized, controlled, open-label parallel group study. All high-dose IFN patients willing to consent will be given a Binding Antibody (BAb) test and if it is positive (>4 units), a Neutralizing Antibody (NAb) test will also be done. Patients will be randomized to one of two arms:

Regularly Scheduled Nab Testing Arm: Patients will be followed-up for 12 months. At least 2 NAb and BAb tests will be performed during the study.

Usual Care Arm: Patients will be followed-up for 12 months under usual care conditions.

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

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

Show 61 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 Neuroscience ( J. Michael Nicholas, Ph.D., Sr. Director, US Regulatory Affairs )
Study ID Numbers:	PM028
Study First Received:	June 12, 2006
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00336557
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:

High-Dose Interferon
Neutralizing Antibodies

Study placed in the following topic categories:

Antibodies
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Multiple sclerosis
Interferons

Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2009