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Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928967
First Posted: June 26, 2009
Last Update Posted: October 9, 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
To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event

Condition Intervention
Multiple Sclerosis Drug: Interferon beta-1b, (Betaseron BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Evolution of the Daily Life score: Analysis of variance for repeated measurements. [ Time Frame: After 1, 3, 6, 9 and 12 months ]

Secondary Outcome Measures:
  • Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements [ Time Frame: Over 12 months ]
  • Correlation coefficient with quality of life scales [ Time Frame: Over 12 months ]
  • Kinetics of treatment discontinuation: Kaplan Meier [ Time Frame: Over 12 months ]
  • Rate of treatment continuation [ Time Frame: After 12 months ]

Biospecimen Retention:   None Retained
n.a.

Enrollment: 67
Study Start Date: May 2007
Study Completion Date: November 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b, (Betaseron BAY86-5046)
The cohort included is described in section 8.5 (inclusion criteria)

  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:   Non-Probability Sample
Study Population
Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria.The choice of treatment must be clearly dissociated from the decision to include the patient in the study.
Criteria

Inclusion Criteria:

  • Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria
  • The choice of treatment must be clearly dissociated from the decision to include the patient in the study.
  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): NCT00928967


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00928967     History of Changes
Other Study ID Numbers: 14168
Daily Life Study ( Other Identifier: company internal )
BF0610FR ( Other Identifier: company internal )
First Submitted: June 23, 2009
First Posted: June 26, 2009
Last Update Posted: October 9, 2015
Last Verified: October 2015

Keywords provided by Bayer:
Multiple Sclerosis
Quality of life

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