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

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ClinicalTrials.gov Identifier: NCT01354665
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


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

Study Type : Observational
Actual Enrollment : 567 participants
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.
Study Start Date : May 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Treatment adherence [ Time Frame: 12 months ]
  3. Clinical course of the disease [ Time Frame: 12 months ]
  4. Overall treatment tolerability as measured by rate of adverse events [ Time Frame: 12 months ]


Information from the National Library of Medicine

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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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01354665     History of Changes
Other Study ID Numbers: 15307
BF1012PL ( Other Identifier: NIS Trial Alias )
First Posted: May 17, 2011    Key Record Dates
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