Depression and Fatigue in MS Patients Treated With Betaferon. (FADO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01354665
First received: May 16, 2011
Last updated: January 19, 2015
Last verified: January 2015
  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.


Condition Intervention
Multiple Sclerosis
Biological: Interferon beta-1b (Betaferon, BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Changes of fatigue score over time [ Time 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of depression score over time [ Time 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 ] [ Designated as safety issue: No ]
  • Treatment adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical course of the disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall treatment tolerability as measured by rate of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 567
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Biological: Interferon beta-1b (Betaferon, BAY86-5046)
Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients previously treated with any immunomodulatory drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354665

Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01354665     History of Changes
Other Study ID Numbers: 15307, BF1012PL
Study First Received: May 16, 2011
Last Updated: January 19, 2015
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
Multiple sclerosis
Interferon beta-1b
Fatigue
Depression

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Interferon beta-1b
Interferon-beta
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 25, 2015