Multiple SclerosisADHERENCENCT03408093
Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
An observational study of Multiple Sclerosis, run by Bayer.
Trial summary
The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b (Betaseron, BAY86-5046)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2009to 30 Mar 2010
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included patients who had been on interferon beta-1b for more than 6 months and who agreed to participate in this study.
Who may be able to join
- Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b
Who cannot join
- -
About this study
Official title: Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046)
- Keywords
- Interferon beta-1b (INFb-1b), Multiple Sclerosis (MS), Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS), Clinically isolated syndrome (CIS)
- Medical subject headings
- Multiple Sclerosis
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
Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.
| Study group | Role | What they receive |
|---|---|---|
| Interferon beta-1b | Patients with CIS, RRMS or SPMS who had more than 6 months in treatment Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test
Measured: Four weeks just before baseline visit
Secondary outcomes (9)
Demographic data
Age, sex, marital status, education level, employment status
Measured: At baseline
Number of patients with MS diagnosis
Measured: At baseline
Age at first episode and at diagnosis
Measured: At baseline
Time since last relapse
Measured: At baseline
Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team
Measured: At baseline
Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS
The EDSS quantifies the disability in eight functional systems (FS) and allows neurologists to assign a level of Functional System in each of them caused by multiple sclerosis.
Measured: At baseline
Number of patients with adverse events during the last month
Measured: Four weeks just before baseline visit
Clinical setting characteristics like existence of MS unit
The existence of Multiple Sclerosis Unit was evaluated bearing in mind if the hospital had or had not available a Multiple Sclerosis Unit into the hospital Neurology Department.
Measured: At baseline
Time on INFb-1b therapy
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start3 Feb 2009
- Primary completion30 Mar 2010
- Study completion30 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 120 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
- NCT03408093
- Sponsor's protocol ID
- 2008/01880
- Other IDs
- 2008
- Acronym
- ADHERENCE
- Status last verified
- Jun 2018
- First submitted
- 8 Jan 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandez O, Aguera E, Izquierdo G, Millan-Pascual J, Ramio I Torrenta L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farres J; Group on Adherence to IFNb-1b in Spain. Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLoS One. 2012;7(5):e35600. doi: 10.1371/journal.pone.0035600. Epub 2012 May 16.
PubMed 22615737
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
- ClinicalTrials.gov ID
- NCT03408093
- Acronym / sponsor ID
- ADHERENCE / 2008/01880
- Conditions
- Multiple Sclerosis
- Keywords
- Interferon beta-1b (INFb-1b), Multiple Sclerosis (MS), Relapsing-remitting MS (RRMS), Secondary progressive MS (SPMS), Clinically isolated syndrome (CIS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2009 (actual)
- Primary completion
- 30 Mar 2010 (actual)
- Study completion
- 30 Mar 2010 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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 the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interferon beta-1b | – | Drug: Interferon beta-1b (Betaseron, BAY86-5046)Patients with CIS, RRMS or SPMS who had more than 6 months in treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included patients who had been on interferon beta-1b for more than 6 months and who agreed to participate in this study.
Key inclusion criteria (1 listed)
- Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b
Key exclusion criteria (1 listed)
- -
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)Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml. | Drug | Interferon beta-1b |
Primary outcome
Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test
Time frame: Four weeks just before baseline visit
9 secondary outcomes
Demographic data
Time frame: At baseline
Number of patients with MS diagnosis
Time frame: At baseline
Age at first episode and at diagnosis
Time frame: At baseline
Time since last relapse
Time frame: At baseline
Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team
Time frame: At baseline
Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS
Time frame: At baseline
Number of patients with adverse events during the last month
Time frame: Four weeks just before baseline visit
Clinical setting characteristics like existence of MS unit
Time frame: At baseline
Time on INFb-1b therapy
Time frame: At baseline
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 21 Jun 2018.
- Results publication: PubMed 22615737Fernandez O, Aguera E, Izquierdo G, Millan-Pascual J, Ramio I Torrenta L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farres J; Group on Adherence to IFNb-1b in Spain. Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLoS One. 2012;7(5):e35600. doi: 10.1371/journal.pone.0035600. Epub 2012 May 16.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Bayer.
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 1 inclusion and 1 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test (time frame: Four weeks just before baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03408093, which also lists 1 linked publication.
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 21 Jun 2018.