Prospective, Multicenter Non Interventional Study to Eval... | NCT01076595

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

NCT01076595

Sponsor

Bayer

Status

Completed

Last Update Posted

Jul 3, 2015Estimated

Enrollment

73Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BF0910FR	Other Identifier	company internal

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Nov 2013Actual

Completion Date

Jul 2014Actual

First Submitted Date

Feb 25, 2010

First Submission Date that Met QC Criteria

Feb 25, 2010

First Posted Date

Feb 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2015

Last Update Posted Date

Jul 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon beta-1b (Betaseron, BAY86-5046)	Drug	Betaferon 250 microgram	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)		24 months

Secondary Outcomes

Measure	Description	Time Frame
Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)		6 months, 12 months, 24 months
Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)		6 months, 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contraindications and warning of the respective Summary of Product Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D012008	Recurrence

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068576	Interferon beta-1b

Ancestor Terms

ID	Term
D016899	Interferon-beta
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines

Browse Leaves

Not provided

Browse Branches

Not provided