Multiple SclerosisNCT00336557
Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy
An observational study of Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 49 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- NAbs testing
- Type of treatment
- Surgery or procedure
- How many people
- 1,230 participants
- Where
- 49 sitesUnited States
- Study dates
- Jul 2006to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have been on high-dose Interferon (IFN) for 1 to 4 years
Who may be able to join
- Willing to provide informed consent.
- Male or female, 18 years of age or older, with a diagnosis of MS.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Abington Neurological Associates
Abington, Pennsylvania, 19001
Neurology Associates of Albany, P.C.
Albany, New York, 12208
Asheville Neurology Specialist, PA
Asheville, North Carolina, 28806
Medical College of Georgia Augusta MS Center
Augusta, Georgia, 30912
Creighton University Department of Neurology
Bellvue, Nebraska, 68123
East Bay Physicians Medical Group
Berkley, California, 94705
NeuroCare Center
Canton, Ohio, 44718
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, 80910
Columbia Center for Neurology and MS
Columbia, Missouri, 65201
Neurology Specialists, Inc
Dayton, Ohio, 45408
Neurology Associates of Monroe County
East Stroudsburg, Pennsylvania, 18301
Colorado Neurosurgery
Engelwood, Colorado, 80113
North Shore Clinical Associates
Erie, Pennsylvania, 16507
The Emery Neuroscience Center
Fort Lauderdale, Florida, 33308
Neuro-Pain Medical Center
Fresno, California, 93710
Fullerton Neurology and Headache Center
Fullerton, California, 92835
Mid-South Physicians
Germantown, Tennessee, 38138
Advanced Neurology Specialist
Great Falls, Montana, 59405
East Carolina Neurology
Greenville, North Carolina, 27834
Alliance for Neuro Research, LLC Absher Neurology
Greenville, North Carolina, 29615
Neurology Associates
Hopedale, Massachusetts, 01747
Lahey Clinic
Lexinton, Massachusetts, 02124
University of Southern California
Los Angeles, California, 90033
Dean Health System
Madison, Wisconsin, 53715
Neurology Associates, PA
Maitland, Florida, 32751
Mankato Clinic
Mankato, Minnesota, 56001
Medford Neurological Clinic,Inc
Medford, Oregon, 97504
The Neuroscience Center of Northern NJ
Morristown, New Jersey, 07960
Collier Neurologic Specialitsts
Naples, Florida, 34102
NYU Hospital for Join Diseases, MS Center
New York, New York, 10003
Comprehensive MS Care Clinic at South Shore Neurology
Patchogue, New York, 11772
Phoenix Neurological Associates, LTD
Phoenix, Arizona, 85006
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Rochester Multiple Sclerosis Center
Rochester, New York, 14642
Central Texas Neurology
Round Rock, Texas, 78681
University of California, Davis
Sacramento, California, 95817
Michigan Neurology Associates
Saint Clair Shores, Michigan, 48080
Central Carolina Neurology & Sleep
Salisbury, North Carolina, 28144
Rocky Mountain Multiple Sclerosis Clinic
Salt Lake City, Utah, 84103
Neurology Clinic of Marin
San Anselmo, California, 94960
Neurology Center of San Antonio, P.A.
San Antonio, Texas, 78212
Neurology Center of San Antonio
San Antonio, Texas, 78232
South Shores Neurology Associates, INC
South Weymouth, Massachusetts, 02190
St John's Mercy Medical Center
St Louis, Missouri, 63141
Axiom Clinical Research of Florida
Tampa, Florida, 33609
University of South Florida
Tampa, Florida, 33612
Oak Clinic
Uniontown, Ohio, 44685
Carle Clinic Association
Urbana, Illinois, 61801
NeuroHealth, INC
Warwick, Rhode Island, 02886
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- NAbs testing
- Keywords
- High-Dose Interferon, Neutralizing Antibodies
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAbs testingProcedure or surgery
blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: NAbs testing | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm
Measured: 1 year
Secondary outcomes (2)
The nature of any therapy/management change in each arm
Measured: 1 year
Reason for change in therapy/management
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Glenski, PharmD, Study chair, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336557
- Sponsor's protocol ID
- PM028
- Status last verified
- Oct 2013
- First submitted
- 12 Jun 2006
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00336557
- Acronym / sponsor ID
- PM028
- Conditions
- Multiple Sclerosis
- Keywords
- High-Dose Interferon, Neutralizing Antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regularly Scheduled NAb Testing Arm | – | Procedure: NAbs testingSubjects 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have been on high-dose Interferon (IFN) for 1 to 4 years
Key inclusion criteria (2 listed)
- Willing to provide informed consent.
- Male or female, 18 years of age or older, with a diagnosis of MS.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAbs testingblood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test. | Procedure or surgery | Regularly Scheduled NAb Testing Arm |
Primary outcome
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
2 secondary outcomes
The nature of any therapy/management change in each arm
Time frame: 1 year
Reason for change in therapy/management
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Glenski, PharmD study chair
Teva Neuroscience, Inc.
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 49 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.