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CompletedNCT03408093ADHERENCEUpdated Jun 21, 2018

Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b

An observational study in Multiple Sclerosis, sponsored by Bayer. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-06-21.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 37 studies in Multiple Sclerosis by Bayer — none open to participants now, 1 under way, none of them phase 3. Multiple Sclerosis · Bayer.

Enrollment
16th of 28
120 · median 145
Started
2009
with 3 others
Observational
28 of 37
none open now
Registered
33rd of 37
by date

Among the 37 studies in Multiple Sclerosis by Bayer, this one is the 16th largest by enrollment of the 28 observational ones that give a count, is one of 4 that started in 2009, is one of 28 observational ones, and was the 33rd registered.

Multiple Sclerosis

3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

None of the 37 studies in Multiple Sclerosis by Bayer is open now. The open studies under Multiple Sclerosis, anywhere →

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 37 studies in Multiple Sclerosis by Bayer as a file.
02

Study 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.

03

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Interferon beta-1b (INFb-1b)
  • Multiple Sclerosis (MS)
  • Relapsing-remitting MS (RRMS)
  • Secondary progressive MS (SPMS)
  • Clinically isolated syndrome (CIS)
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • Interferon beta-1b

    Patients with CIS, RRMS or SPMS who had more than 6 months in treatment

    Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Interventions

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Demographic data

    Age, sex, marital status, education level, employment status

    Time frame: At baseline

  2. Number of patients with MS diagnosis

    Time frame: At baseline

  3. Age at first episode and at diagnosis

    Time frame: At baseline

  4. Time since last relapse

    Time frame: At baseline

  5. Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team

    Time frame: At baseline

  6. 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.

    Time frame: At baseline

  7. Number of patients with adverse events during the last month

    Time frame: Four weeks just before baseline visit

  8. 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.

    Time frame: At baseline

  9. Time on INFb-1b therapy

    Time frame: At baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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. Erratum In: PLoS One. 2012;7(6). doi:10.1371/annotation/35c70f05-8483-4310-aa2a-4665f4842129. Aguera, Javier [corrected Aguera, Eduardo]; Millan-Pascual, Javier [corrected to Millan-Pascual, Jorge]Argente, Javier [correced to Argente, Joaquin]. PubMed 22615737 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2009 to primary completion in Mar 2010, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2018
First posted
Jan 23, 2018
StartActual
Feb 3, 2009
Primary completionActual
Mar 30, 2010
CompletionActual
Mar 30, 2010
Last update
Jun 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03408093
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Feb 3, 2009
Primary completion
Mar 30, 2010
Completion
Mar 30, 2010
Last update
Jun 21, 2018

Study contacts

Bayer Study Director
study director · Bayer

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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