Clinical trial NCT00336557: Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: High-Dose Interferon
Neutralizing Antibodies
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-13
Enrollment: 1230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have been on high-dose Interferon (IFN) for 1 to 4 years

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.

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 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.

Primary outcomes:
measure: Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm
timeFrame: 1 year
Secondary outcomes:
measure: The nature of any therapy/management change in each arm
timeFrame: 1 year
measure: Reason for change in therapy/management
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Neurological Associates, LTD
state: Arizona
city: Berkley
country: United States
facility: East Bay Physicians Medical Group
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Fullerton
country: United States
facility: Fullerton Neurology and Headache Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Anselmo
country: United States
facility: Neurology Clinic of Marin
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates, PC
state: Colorado
city: Engelwood
country: United States
facility: Colorado Neurosurgery
state: Colorado
city: Ft. Lauderdale
country: United States
facility: The Emery Neuroscience Center
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, PA
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialitsts
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia Augusta MS Center
state: Georgia
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Hopedale
country: United States
facility: Neurology Associates
state: Massachusetts
city: Lexinton
country: United States
facility: Lahey Clinic
state: Massachusetts
city: South Weymouth
country: United States
facility: South Shores Neurology Associates, INC
state: Massachusetts
city: St Clair Shores
country: United States
facility: Michigan Neurology Associates
state: Michigan
city: Mankato
country: United States
facility: Mankato Clinic
state: Minnesota
city: Columbia
country: United States
facility: Columbia Center for Neurology and MS
state: Missouri
city: St Louis
country: United States
facility: St John's Mercy Medical Center
state: Missouri
city: Great Falls
country: United States
facility: Advanced Neurology Specialist
state: Montana
city: Bellvue
country: United States
facility: Creighton University Department of Neurology
state: Nebraska
city: Morristown
country: United States
facility: The Neuroscience Center of Northern NJ
state: New Jersey
city: Albany
country: United States
facility: Neurology Associates of Albany, P.C.
state: New York
city: New York
country: United States
facility: NYU Hospital for Join Diseases, MS Center
state: New York
city: Patchogue
country: United States
facility: Comprehensive MS Care Clinic at South Shore Neurology
state: New York
city: Rochester
country: United States
facility: Rochester Multiple Sclerosis Center
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialist, PA
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Neurology
state: North Carolina
city: Greenville
country: United States
facility: Alliance for Neuro Research, LLC Absher Neurology
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Salisbury
country: United States
facility: Central Carolina Neurology & Sleep
state: North Carolina
city: Canton
country: United States
facility: NeuroCare Center
state: Ohio
city: Dayton
country: United States
facility: Neurology Specialists, Inc
state: Ohio
city: Uniontown
country: United States
facility: Oak Clinic
state: Ohio
city: Medford
country: United States
facility: Medford Neurological Clinic,Inc
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Neurology Associates of Monroe County
state: Pennsylvania
city: Erie
country: United States
facility: North Shore Clinical Associates
state: Pennsylvania
city: Warwick
country: United States
facility: NeuroHealth, INC
state: Rhode Island
city: Germantown
country: United States
facility: Mid-South Physicians
state: Tennessee
city: Round Rock
country: United States
facility: Central Texas Neurology
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio, P.A.
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Multiple Sclerosis Clinic
state: Utah
city: Madison
country: United States
facility: Dean Health System
state: Wisconsin
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Stephen Glenski, PharmD
role: STUDY_CHAIR
References: