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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01354665
First received: May 16, 2011
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

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: 252
Study Start Date: May 2010
Study Completion Date: May 2012
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
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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Sp. z o.o. A. Jerozolimskie 158, Warsaw 02-326, Poland
ClinicalTrials.gov Identifier: NCT01354665     History of Changes
Other Study ID Numbers: 15307, BF1012PL
Study First Received: May 16, 2011
Last Updated: October 11, 2012
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:
Depression
Depressive Disorder
Fatigue
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 23, 2013