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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336557
• Other study ID #: PM028
• Status: Completed
• Phase: Phase 4
• First received: June 12, 2006
• Last updated: October 29, 2013
• Start date: July 2006
• Est. completion date: July 2009

Study information

• Verified date: October 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Procedure:
• NAbs testing
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.

Locations

Country	Name	City	State
United States	Abington Neurological Associates	Abington	Pennsylvania
United States	Neurology Associates of Albany, P.C.	Albany	New York
United States	Asheville Neurology Specialist, PA	Asheville	North Carolina
United States	Medical College of Georgia Augusta MS Center	Augusta	Georgia
United States	Creighton University Department of Neurology	Bellvue	Nebraska
United States	East Bay Physicians Medical Group	Berkley	California
United States	NeuroCare Center	Canton	Ohio
United States	Colorado Springs Neurological Associates, PC	Colorado Springs	Colorado
United States	Columbia Center for Neurology and MS	Columbia	Missouri
United States	Neurology Specialists, Inc	Dayton	Ohio
United States	Neurology Associates of Monroe County	East Stroudsburg	Pennsylvania
United States	Colorado Neurosurgery	Engelwood	Colorado
United States	North Shore Clinical Associates	Erie	Pennsylvania
United States	Neuro-Pain Medical Center	Fresno	California
United States	The Emery Neuroscience Center	Ft. Lauderdale	Florida
United States	Fullerton Neurology and Headache Center	Fullerton	California
United States	Mid-South Physicians	Germantown	Tennessee
United States	Advanced Neurology Specialist	Great Falls	Montana
United States	Alliance for Neuro Research, LLC Absher Neurology	Greenville	North Carolina
United States	East Carolina Neurology	Greenville	North Carolina
United States	Neurology Associates	Hopedale	Massachusetts
United States	Lahey Clinic	Lexinton	Massachusetts
United States	University of Southern California	Los Angeles	California
United States	Dean Health System	Madison	Wisconsin
United States	Neurology Associates, PA	Maitland	Florida
United States	Mankato Clinic	Mankato	Minnesota
United States	Medford Neurological Clinic,Inc	Medford	Oregon
United States	The Neuroscience Center of Northern NJ	Morristown	New Jersey
United States	Collier Neurologic Specialitsts	Naples	Florida
United States	NYU Hospital for Join Diseases, MS Center	New York	New York
United States	Comprehensive MS Care Clinic at South Shore Neurology	Patchogue	New York
United States	Phoenix Neurological Associates, LTD	Phoenix	Arizona
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Rochester Multiple Sclerosis Center	Rochester	New York
United States	Central Texas Neurology	Round Rock	Texas
United States	University of California, Davis	Sacramento	California
United States	Central Carolina Neurology & Sleep	Salisbury	North Carolina
United States	Rocky Mountain Multiple Sclerosis Clinic	Salt Lake City	Utah
United States	Neurology Clinic of Marin	San Anselmo	California
United States	Neurology Center of San Antonio	San Antonio	Texas
United States	Neurology Center of San Antonio, P.A.	San Antonio	Texas
United States	South Shores Neurology Associates, INC	South Weymouth	Massachusetts
United States	Michigan Neurology Associates	St Clair Shores	Michigan
United States	St John's Mercy Medical Center	St Louis	Missouri
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Oak Clinic	Uniontown	Ohio
United States	Carle Clinic Association	Urbana	Illinois
United States	NeuroHealth, INC	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm		1 year	No
Secondary	The nature of any therapy/management change in each arm		1 year	No
Secondary	Reason for change in therapy/management		1 year	No