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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01354665
First Posted: May 17, 2011
Last Update Posted: January 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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 ]

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 ]
  • Treatment adherence [ Time Frame: 12 months ]
  • Clinical course of the disease [ Time Frame: 12 months ]
  • Overall treatment tolerability as measured by rate of adverse events [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354665


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01354665     History of Changes
Other Study ID Numbers: 15307
BF1012PL ( Other Identifier: NIS Trial Alias )
First Submitted: May 16, 2011
First Posted: May 17, 2011
Last Update Posted: January 21, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Depression
Sclerosis
Multiple Sclerosis
Fatigue
Multiple Sclerosis, Relapsing-Remitting
Behavioral Symptoms
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic