NCT01354665

Brief Summary

This study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of Betaferon treatment on symptoms alterations. The study is conducted in routine practice setting hence no interference with standard care takes place. Pharmacologic treatments of MS-fatigue and depression will also be recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
567

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

3.1 years

First QC Date

May 16, 2011

Last Update Submit

January 19, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisInterferon beta-1bFatigueDepression

Outcome Measures

Primary Outcomes (1)

  • Changes of fatigue score over time

    short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline

Secondary Outcomes (4)

  • Changes of depression score over time

    short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline

  • Treatment adherence

    12 months

  • Clinical course of the disease

    12 months

  • Overall treatment tolerability as measured by rate of adverse events

    12 months

Study Arms (1)

Group 1

Biological: Interferon beta-1b (Betaferon, BAY86-5046)

Interventions

Interferon beta-1b (Betaferon, BAY86-5046)BIOLOGICAL

Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with relapsing form of multiple sclerosis treated with Betaferon under routine practice setting.

You may qualify if:

  • Relapsing-remitting multiple sclerosis
  • Age 18+
  • Patients initiating Betaferon treatment

You may not qualify if:

  • Patients previously treated with any immunomodulatory drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Poland

Location

MeSH Terms

Conditions

Multiple SclerosisFatigueDepression

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 17, 2011

Study Start

May 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

PL(1)