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Multiple SclerosisSEPLUSNCT01076595

Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period

An observational study of Multiple Sclerosis, run by Bayer at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program 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?
Interferon beta-1b (Betaseron, BAY86-5046)
How many people
73 participants
Where
1 siteFrance
Study dates
May 2010to Jul 2014
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: Outpatients

Who may be able to join

  • Male or female >/= 18 years old
  • Outpatient with a confirmed diagnosis of Recurrent-Remittent multiple sclerosis or patients at high risk of developing multiple sclerosis after a first demyelinating clinical event
  • Patient who initiated Betaferon as described by SmPC less than 2 months ago. The decision of physician is clearly separated from the decision to include the patient in the study
  • Treatment naïve patients before the initiation of Betaferon
  • OR Patients having interrupted Betaferon for more than 6 months before to start again
  • OR Patients receiving a disease modifying drug (DMD) other than Betaferon
  • Patient with EDSS score < 4
  • Patients approved and signed an inform consent and approved the collect of their data

Who cannot join

  • Contraindications and warning of the respective Summary of Product Characteristics

Trial locations and contacts

1 site in 1 country.

France1 site

  • Study site

    Many Locations

Other trials in France

About this study

Official title: Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program

The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program

Being tested
Interferon beta-1b (Betaseron, BAY86-5046)
Keywords
Multiple sclerosis, BetaPlus program, Recurrent/remittent multiple sclerosis patients, Adherence to treatment regimen
Medical subject headings
Multiple Sclerosis, Recurrence

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

    Betaferon 250 microgram

Study groups in NCT01076595
Study groupRoleWhat they receive
Group 1Not described
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.

  1. The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)

    Measured: 24 months

Secondary outcomes (10)

  1. Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)

    Measured: 6 months, 12 months, 24 months

  2. Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)

    Measured: 6 months, 12 months

  3. Rate of patients with prematurely study discontinuation

    Measured: 0-6 months, 6-12 months, 12-18 months, 18-24 months

  4. Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections)

    Measured: 24 months

  5. Tolerability of Betaferon injections (rate and number of injections)

    Measured: 24 months

  6. Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])

    Measured: 24 months

  7. Fatigue (mean total score of FSS [Fatigue Severity scale])

    Measured: 24 months

  8. Progression of clinical Condition( annual rate of Relapses)

    Measured: 24 months

  9. Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study

    Measured: 24 months

  10. Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionNov 2013
  4. Study completionJul 2014

Resources

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
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01076595
Sponsor's protocol ID
15098
Other IDs
BF0910FR
Acronym
SEPLUS
Status last verified
Jul 2015
First submitted
25 Feb 2010
Last updated
3 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Bayer at 1 site in France.

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 8 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months) (time frame: 24 months). 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 NCT01076595.

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 3 Jul 2015.

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SEPLUS Clinical Trial NCT01076595 | AzTrials