Multiple Sclerosis, Relapsing-RemittingNCT02652091
Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 23 sites in United States.
Trial summary
The primary objective of this study is to assess adherence and persistence to BETASERON therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device). The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Interferon beta-1b (Betaseron, BAY86-5046) and BETACONNECT device
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 23 sitesUnited States
- Study dates
- 5 Feb 2016to 13 Sep 2017
- 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: Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS)
Who may be able to join
- Male and females greater than or equal to 18 years of age
- Diagnosis of RRMS according to revised McDonald Criteria (2010) or (CIS)
- Prescribed BETASERON (note: decision to treat with BETASERON must be made independent of participation in this study)
- Confirmation of insurance coverage for BETASERON treatment
- Access to a personal computer to complete online patient satisfaction survey at Week 6
Who cannot join
- Currently enrolled in a clinical trial or other observational study for Multiple Sclerosis treatment
- Documented substance abuse within the previous 6 months prior to study enrollment
- Any major laboratory value abnormality that the investigator believes would preclude the patient from participating in the study
- Any medical disorder, condition or history that in the opinion of the investigator would impair the patient's ability to participate in or complete the study
- Pregnant or nursing
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Study site
Atlanta, Georgia, 30309-1465
Study site
Bala-Cynwyd, Pennsylvania, 19004
Study site
Boca Raton, Florida, 33428
Study site
Cullman, Alabama, 35058
Study site
Deckerville, Michigan, 48427
Study site
Fairfax, Virginia, 22031
Study site
Foxborough, Massachusetts, 02035
Study site
Franklin, Tennessee, 37064
Study site
Fulton, Maryland, 20759
Study site
Lititz, Pennsylvania, 17543
Study site
Lubbock, Texas, 79430
Study site
Medford, Oregon, 97504
Study site
Medford, Oregon
Study site
Memphis, Tennessee, 38104
Study site
Nashville, Tennessee, 37212
Study site
New Port Richey, Florida, 34653
Study site
Round Rock, Texas, 78681
Study site
St Louis, Missouri, 63131
Study site
Staten Island, New York, 10306
Study site
Stratford, New Jersey, 08084
Study site
Tampa, Florida, 33609
Study site
Teaneck, New Jersey, 07666
Study site
Virginia Beach, Virginia
About this study
The primary objective of this study is to assess adherence and persistence to BETASERON therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).
The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046), BETACONNECT device
- Keywords
- Adherence, Persistence, Patient satisfaction
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaseron, BAY86-5046)Drug
Applied via the BETACONNECT device. Dose as prescribed by physician.
BETACONNECT deviceDevice
Used to apply Betaseron.
| Study group | Role | What they receive |
|---|---|---|
| Interferon beta-1b | Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device. Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046); Device: BETACONNECT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of BETASERON injections as captured by the BETACONNECT device
Measured: At 6 months
Time (days) between BETASERON injections as captured by BETACONNECT device
Measured: At 6 months
Secondary outcomes (1)
Patient reported satisfaction by a questionnaire
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start5 Feb 2016
- Primary completion11 Aug 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652091
- Sponsor's protocol ID
- 17942
- Status last verified
- Sep 2018
- First submitted
- 5 Jan 2016
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT02652091
- Acronym / sponsor ID
- 17942
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Adherence, Persistence, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2016 (actual)
- Primary completion
- 11 Aug 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 11 Jan 2016 (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 objective of this study is to assess adherence and persistence to BETASERON therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).
The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interferon beta-1b | – | Drug: Interferon beta-1b (Betaseron, BAY86-5046), Device: BETACONNECT devicePatients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS)
Key inclusion criteria (5 listed)
- Male and females greater than or equal to 18 years of age
- Diagnosis of RRMS according to revised McDonald Criteria (2010) or (CIS)
- Prescribed BETASERON (note: decision to treat with BETASERON must be made independent of participation in this study)
- Confirmation of insurance coverage for BETASERON treatment
- Access to a personal computer to complete online patient satisfaction survey at Week 6
Key exclusion criteria (5 listed)
- Currently enrolled in a clinical trial or other observational study for Multiple Sclerosis treatment
- Documented substance abuse within the previous 6 months prior to study enrollment
- Any major laboratory value abnormality that the investigator believes would preclude the patient from participating in the study
- Any medical disorder, condition or history that in the opinion of the investigator would impair the patient's ability to participate in or complete the study
- Pregnant or nursing
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 beta-1b (Betaseron, BAY86-5046)Applied via the BETACONNECT device. Dose as prescribed by physician. | Drug | Interferon beta-1b |
| BETACONNECT deviceUsed to apply Betaseron. | Device | Interferon beta-1b |
Primary outcome
Number of BETASERON injections as captured by the BETACONNECT device
Time frame: At 6 months
Time (days) between BETASERON injections as captured by BETACONNECT device
Time frame: At 6 months
1 secondary outcome
Patient reported satisfaction by a questionnaire
Time frame: At 6 weeks
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 6 Sep 2018.
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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
23 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, Relapsing-Remitting, run by Bayer at 23 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 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Number of BETASERON injections as captured by the BETACONNECT device (time frame: At 6 months). The study lists 2 primary outcomes in all. 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 6 Sep 2018.