Multiple SclerosisSTARTNCT00461396
Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron
An observational study of Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 19 sites in United States.
Trial summary
The primary aim of this study is to evaluate the impact of titration, analgesics, and 12 month telephone follow-up period from the B.E.T.A nurse program upon adherence to treatment with Betaseron in patients with a first clinical demyelinating event suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Interferon-1beta (Betaseron, BAY86-5046)
- How many people
- 104 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2007to Nov 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Community sample
Who may be able to join
- Have no cognitive impairment that may prevent patient from completing questionnaires, as assessed by examining physicians during screening
- Diagnosis of early (<1 year since onset) RRMS, or a first clinical episode suggestive of demyelinating disease (not explained by other conditions) within the last 90 days prior to screening
- Presence of at least 2 typical MS lesions by brain MRI
- Kurtzke Expanded Disability Status Scale (EDSS) score of 0 - 4.0
- Willing to enroll into the MS Pathways support program and by doing so agree to be trained, and have follow-up phone calls, by a B.E.T.A. nurse
Who cannot join
- Any disease other than multiple sclerosis that would better explain the patient's neurological signs and symptoms
- Complete transverse myelitis or simultaneous onset of optic neuritis
- Diagnosis of Primary progressive MS, secondary Progressive MS, relapsing progressive MS or a diagnosis of relapsing remitting MS for greater than 12 months
- Clinically significant heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled heart failure
- History of severe, uncontrolled, or untreated depression, attempted suicide or suicidal ideation
- Uncontrolled seizure disorder
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- History or hypergammaglobulinemia
- Known hypersensitivity to IFNB-1b or other human proteins including albumin
- Known allergy to Gadolinium-DTPA documented prior to study entry
- Known general hypersensitivity to all analgesic / antiinflammatory agents (NSAIDs)
- Participation in any MS clinical study within the past six months
- Pre-treatment with any of the following substances prior to study enrollment within said time period:
- At any time: any IFN, glatiramer acetate (Copaxone), total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (i.e. anti-CD4, anti-CD52 (alemtuzumab), anti-VLA4 (natalizumab), mitoxantrone, cyclophosphamide, azathioprine, IVIG, cyclosporine A, methotrexate, or any other immunomodulating or immunosuppressive agent including other recombinant or non-recombinant cytokines
- 3 months prior to study entry: any other treatment known to be used for putative or experimental MS treatment. Any presumed immunomodulating agent (e.g. statins) not described in this protocol
- History of alcohol or substance abuse (within the past 5 years)
- Inability or unwillingness to administer subcutaneous injections either by self or by caregiver
- Clinically significant hepatic, renal, or bone marrow dysfunction as defined by any of the following laboratory evaluations:
- Hepatic dysfunction: AST (SGOT) > 3x the upper limit of normal or total bilirubin > 2x upper limit of normal
- Renal dysfunction: creatinine > 1.8 mg/dl
- Bone marrow dysfunction: Hb < 8.5 g/dl, WBC < 2.5x10^9/L, or platelet count < 125x10^9/L
- Patients participating in the exploratory substudy should be excluded if they meet any of the following:
- Known history of chronic glaucoma, ocular hypertension, ischemic optic neuropathy, temporal arteritis, pseudopapilledema, retinitis pigmentosa, traumatic optic neuropathy, toxic optic neuropathy, pernicious anemia, or Leber's hereditary optic neuritis
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Many Locations, Alabama
Study site
Many Locations, Arizona
Study site
Many Locations, Delaware
Study site
Many Locations, District of Columbia
Study site
Many Locations, Florida
Study site
Many Locations, Georgia
Study site
Many Locations, Illinois
Study site
Many Locations, Iowa
Study site
Many Locations, Louisiana
Study site
Many Locations, Maine
Study site
Many Locations, Minnesota
Study site
Many Locations, Missouri
Study site
Many Locations, New Jersey
Study site
Many Locations, New York
Study site
Many Locations, North Carolina
Study site
Many Locations, Ohio
Study site
Many Locations, Pennsylvania
Study site
Many Locations, Tennessee
Study site
Many Locations, West Virginia
About this study
Official title: Open-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 Months
- The primary aim of this study is to evaluate the impact of titration, analgesics, and 12 month telephone follow-up period from the B.E.T.A nurse program upon adherence to treatment with Betaseron in patients with a first clinical demyelinating event suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12 months
- Secondary outcomes include analysis of the following parameters: progression of clinical severity by the expanded disability status scale (EDSS score), health related quality of life (HrQoL), and safety.
- Exploratory outcomes include changes over time in cytokine and neurotrophic factor production by immune cells and visual function as assessed by visual examination, OCT measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire (NEI-VFQ-25) with 10-item supplement.
- Being tested
- Interferon-1beta (Betaseron, BAY86-5046)
- Keywords
- Relapsing-Remitting Multiple Sclerosis, First demyelinating event, MRI features consistent with MS
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-1beta (Betaseron, BAY86-5046)Drug
Male and females, 18 to 50 years of age, after a first clinical demyelinating event suggestive of multiple sclerosis or with onset of RRMS within the past 12 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Interferon-1beta (Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment
Measured: 12 months
Secondary outcomes (4)
Extended Disability Status Scale (EDSS)
Measured: 12 months
Functional Assessment in Multiple Sclerosis (FAMS)
Measured: 12 months
Cytokine and neurotrophic factor production
Measured: 12 months
Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionNov 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.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461396
- Sponsor's protocol ID
- 14465
- Other IDs
- 311501, BF0713US
- Acronym
- START
- Status last verified
- Apr 2011
- First submitted
- 17 Apr 2007
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 Months
- ClinicalTrials.gov ID
- NCT00461396
- Acronym / sponsor ID
- START / 14465
- Keywords
- Relapsing-Remitting Multiple Sclerosis, First demyelinating event, MRI features consistent with MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Apr 2007 (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.
- The primary aim of this study is to evaluate the impact of titration, analgesics, and 12 month telephone follow-up period from the B.E.T.A nurse program upon adherence to treatment with Betaseron in patients with a first clinical demyelinating event suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12 months
- Secondary outcomes include analysis of the following parameters: progression of clinical severity by the expanded disability status scale (EDSS score), health related quality of life (HrQoL), and safety.
- Exploratory outcomes include changes over time in cytokine and neurotrophic factor production by immune cells and visual function as assessed by visual examination, OCT measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire (NEI-VFQ-25) with 10-item supplement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Interferon-1beta (Betaseron, BAY86-5046) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (5 listed)
- Have no cognitive impairment that may prevent patient from completing questionnaires, as assessed by examining physicians during screening
- Diagnosis of early (<1 year since onset) RRMS, or a first clinical episode suggestive of demyelinating disease (not explained by other conditions) within the last 90 days prior to screening
- Presence of at least 2 typical MS lesions by brain MRI
- Kurtzke Expanded Disability Status Scale (EDSS) score of 0 - 4.0
- Willing to enroll into the MS Pathways support program and by doing so agree to be trained, and have follow-up phone calls, by a B.E.T.A. nurse
Key exclusion criteria (22 listed)
- Any disease other than multiple sclerosis that would better explain the patient's neurological signs and symptoms
- Complete transverse myelitis or simultaneous onset of optic neuritis
- Diagnosis of Primary progressive MS, secondary Progressive MS, relapsing progressive MS or a diagnosis of relapsing remitting MS for greater than 12 months
- Clinically significant heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled heart failure
- History of severe, uncontrolled, or untreated depression, attempted suicide or suicidal ideation
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 |
|---|---|---|
| Interferon-1beta (Betaseron, BAY86-5046)Male and females, 18 to 50 years of age, after a first clinical demyelinating event suggestive of multiple sclerosis or with onset of RRMS within the past 12 months | Drug | Group 1 |
Primary outcome
Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment
Time frame: 12 months
4 secondary outcomes
Extended Disability Status Scale (EDSS)
Time frame: 12 months
Functional Assessment in Multiple Sclerosis (FAMS)
Time frame: 12 months
Cytokine and neurotrophic factor production
Time frame: 12 months
Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire)
Time frame: 18 months
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 8 Apr 2011.
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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.
Bayer Study Director study director
Bayer
19 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 and Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 19 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 5 inclusion and 22 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 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment (time frame: 12 months). 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 8 Apr 2011.