check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

15307

ClinicalTrials.gov Identifier:

NCT01354665

EudraCT Number:

Not Available

EU CT Number:

Not Available
Depression and fatigue in MS patients treated with Betaferon.

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

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



  • - Patients previously treated with any immunomodulatory drug

Trial summary

Enrollment Goal
567
Trial Dates
May 2010 - June 2013
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Poland

Primary Outcome

  • Changes of fatigue score over time
    date_rangeTime Frame:
    short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
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    Safety Issue:
    No

Secondary Outcome

  • Changes of depression score over time
    date_rangeTime Frame:
    short-term, mid-term and long-term changes will be assessed: 3 months vs. baseline, 6 months vs. baseline and 12 months vs. baseline
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    Safety Issue:
    No
  • Treatment adherence
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    No
  • Clinical course of the disease
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    No
  • Overall treatment tolerability as measured by rate of adverse events
    date_rangeTime Frame:
    12 months
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    Safety Issue:
    Yes

Trial design

The short-term effect of immunomodulatory treatment with interferon beta-1b (Betaferon) on fatigue and depression in first-time treated patients with relapsing-remitting multiple sclerosis.
Trial Type
Observational
Intervention Type
Biological/Vaccine
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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